Clinical Evaluation Report HF-400

Clinical Evaluation Report of HF-400
SAAKSHI MEDTECH AND PANELS LIMITED DOC ID: HF 400/CED/01
(Erstwhile known as Saakshi Machine and Tools Pvt Ltd) Date: 07/08/2023.Rev. 0
1. INTRODUCTION
1.1 Purpose
Clinical Evaluation is a methodologically sound ongoing assessment of clinical performance

and safety of Medical devices. During the clinical evaluation procedure collection, appraisal
and analyses of clinical data pertaining to a medical device or equivalent devices is
completed. The clinical evaluation is based on an objective and critical analysis of available
data relevant to the intended purpose of a medical device including both pre-clinical and
clinical data. Its purpose is to assure conformity to the requirements of the device under
evaluation using the device according to manufacturers Instruction for use (IfU)[R1] and is
part of the technical documentation. The results of the clinical evaluation performed on HF-
400 and the clinical evidence on which the evaluation is based are documented within this
report.
1.2 SCOPE:
The clinical evaluation documented in this report is based on scientific literature currently
available on the listed devices and predicate or equivalent devices.
Table 1 Device Details

Device Name HF 400
Device Classification Class “C” as per IMDR-2017
Manufacturer Name SAAKSHI MEDTECH AND PANELS
LIMITED (Erstwhile known as
Saakshi Machine and Tools Pvt Ltd)
Manufacturer Address El-22 “ J” Block, MIDC, Bhosari,
Pune, Maharashtra,
India-411026
Email Id: aniket.l@smtpl.co
Website: www.smtpl.co
Phone: 02039854401/7709151631
Table 2 Device, Components and Accessories.

Name Details
HF 400 System The HF 400 system consists of a
Tube stand with X-ray tube, a
Multiposition table, a generator
with generator console. Refer to
Technical Data in the IFU [R1].
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PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍
Accessories Register 1. Patient Abdomen Binder

2. Patient Grip Handles
3. Patient Footrest
2. Device Description
2.1 General Device Description of HF-400
The HF 400 system consists of a Tube stand with X-ray tube, a Multiposition table, a generator
with generator console.
The Multiposition table is an X-ray Table used for the x-ray examinations from head to toe. It
allows exposures to fulfill the clinical applications for all standard radiological diagnostics for
Example, thorax, lungs, abdomen, extremities, spine, skull, and hip on lying, sitting, standing
patient as well as free exposures. Its installation, service, and user-friendly design always
ensure efficient operation of the unit.
The basic unit consists of a patient table with a tabletop and a Bucky cabinet as well as a
guided tube stand for holding X-ray tube, Collimator, and control arm. The Brake Pedal on
the table base close to the floor is used for releasing the mechanical locks and helps in tilting
the table both in clock and anticlockwise direction which allows fast and easy patient
positioning. The table is equipped with lateral profile rails to accommodate accessories. The
Bucky cabinet is moved manually under the tabletop in the longitudinal direction and
stopped by mechanical locks. The Bucky tray lock is opened using the handle on the front
side of the Bucky cabinet. The tube stand for the X-ray tube support arm and tube unit moves
in the rail parallel to the table's longitudinal axis.
The X-ray tube unit with Collimator and control arm for the tube stand is attached to the
swivelling tube support arm. It is moved vertically and rotated about the longitudinal axis of
the tube support arm. These movement possibilities allow vertical, horizontal, or oblique
beam projections. Each position is locked manually.
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Unit Overview
3
Table 3 Unit overview

No. Details
1 Multiposition table (Manually Operated)
2 Profile rails to accommodate accessories
3 Table top
4 Bucky unit (Backside)
5 Base of the tube stand with rails
6 Tube stand
7 X-ray tube unit
8 Collimator (Manually Operated)
4
Table 4 Unit Overview (Part2)

No. Details
9 Handle for patient table
10 Scale for SID measurement
11 Vertical Carriage
12 Brake Pedal
13 Tube support arm (Telescopic for in out movement for alignment
with table bucky and free cassette exposures)
For the details on operating of different elements of the system, please refer to use manual
of the system [R1].
For the details on preparation of the system and operator, please refer to user manual of the
system [R1].
For the details on workflow to obtain radiographs, please refer to user manual of the system
[R1].
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Functional Diagram:
Figure 1 Functional Diagram with cable details

2.2 Design Configuration:
The device consists of several components that can be combined to form an X-ray system.
Following are list of system components:
Standard Version
 Multiposition table and floor to ceiling mounted tube stand
 X-ray Generator, PXR-321B(32KW) Including OP Console
 X-ray tube with Collimator
 Static balancer 50 KVA
2.3 Intended purpose of the device:

2.3.1 Intended use:
The HF 400 system is intended for taking X-ray examinations which can be coupled with any
other solutions for a medical diagnosis of various human diseases or injuries.
Clinical Applications
The HF 400 system can be used for routine X-ray examinations on patients in the standing,
seated or lying positions.
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This includes standard radiography procedures such as:

 X-ray examinations of the skeleton including skull, ribs, spine, pelvis, upper
extremities, lower extremities, etc.
 X-ray examinations of the lung or chest
 X-ray examinations of soft tissue such as abdomen
 Trauma cases
The examinations are known in medical routine and are described in medical literature.
System is operated only in accordance with the safety procedures and operating instructions
given in the system manual [R1].
2.3.2 Radiation Safety
Prior to patient examination the personnel / Staff must brief the patient on contra-
indications and precautions to be taken against radiation.
 Special consideration must be given to the protection of the embryo or fetus during
radiological examination or treatment of women known to be pregnant.
 Sensitive body organs (e.g: Lens of eye, gonads) must be shielded whenever they are
likely to be exposed to the working beam.
 Acute skin burns & Hair loss (patients)
 Chronic radiation injury (staff).
Due to the nature of X-ray procedures the patient is exposed to a radiation and adverse
health effects exist and are well known. Therefore the responsible radiologist must assess
risks and benefits and identify relevant contraindications depending on example on available
alternative diagnosis technologies.
2.3.3 Warnings and Precautions
In Saakshi Medtech and Panels Ltd, Products are all designed to meet stringent safety
standards. However, all medical electrical equipment requires proper operation and
maintenance, particularly with regard to human safety. It is vital that user read, note, and
where applicable strictly observe all DANGER notices and safety markings on the HF 400
system. It is vital that you follow strictly all safety directions under the heading SAFETY and
all WARNINGS and CAUTIONS throughout this manual, to help ensure the safety of both
patients and operators before attempting to use the equipment for any patient examination.
User should note the Important safety directions as mentioned in User manual of the system
[R1].
2.3.4 Intended user

The ‘user’ is considered to be a person with authority over the equipment; ‘operators’ are
those persons who actually handle the equipment.
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Before attempting to operate the equipment, User/ Operator must read this manual
thoroughly, paying particular attention to all WARNINGS, CAUTIONS and NOTES incorporated
in it. User/Operator must pay special attention to all the information given and procedures
described in Section 2, ‘Safety’ of the Manual [R1].
Operators of the HF 400 system must have received adequate training on its safe and
effective use before attempting to operate the equipment described in this manual. Training
requirements for this type of device will vary from country to country. It is for users to make
sure that operators receive adequate training in accordance with local laws or regulations
which have the force of law if you require further information about training in the use of
this equipment, please contact Saakshi Medtech and panels Limited.
2.3.5 Clinical benefits:

Plain radiography can provide detailed information to diagnose, plan treatment and evaluate
many conditions in adults and children.
2.3.6 Compatibility
Equipment described in this manual should not be used in combination with other
equipment or components unless such other equipment or components are expressly
recognized as compatible by Saakshi. Such changes and/or additions must comply with all
applicable laws and regulations that have the force of law within the jurisdiction(s)
concerned, and with best engineering practice. Changes and/or additions to the equipment
that are carried out by persons without the appropriate training and/or using unapproved
spare parts may lead to the warranty being voided. As with all complex technical equipment,
maintenance by persons not appropriately qualified and/or using unapproved spare parts
carries serious risks of damage to the equipment and of personal injury.
2.3.7 Device Development plan
The device has been manufactured according to the Quality Management Manual of Saakshi
[R2]. The scope of the Quality management system is “DESIGN, MANUFACTURING & SUPPLY
OF X-RAY EQUIPMENT”. The quality system manual is certified according to ISO 13485:2016.
Furthermore, the device is developed according to following Standards:
 IS 7620
 IEC 60601-1
 IEC 60601-2-54
 AERB (Manufaturing License and Product type Approval)
 CDSCO (Test License - Form MD-130
 ISO 14971
 ISO/IEC 17025:2017
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The HF 400 system is not considered as novel technology and are purely based on well
established diagnostic X-ray imaging technologies. The risk management activities were
adequate to determine the safe development and maintenance of the medical device.
Hereby the CER report is based on the pre-clinical data and literature review of the device
and /or predicate/equivalent devices (Described in Chapter 4).
3. Risk Management
The risk management process is integral part of the QMS of Saakshi Medtech[R2]. The risk
management process is performed as per the international standard ISO 14971. It is the
process that is required for the safe development and maintenance of all medical devices.
The following risk management documentation is applicable:
Document Reference
Risk Management Plan F/MR/15,Rev/Date:-
00/01/12/2021
Risk Management and control F/MR/08A Rev :-00Date:-20-12-21
Risk Management Summary / F/MR/16 Date: 01/12/2021
Report
3.1 Conclusions of Risk Management
This Risk Management Summary and Report serves as a high-level summary of the risk
management activities, as described in the Risk Management Plan (RMP), that have been
followed and completed for the HF-400.
Overall residual risks are acceptable. They have met the risk acceptance criteria as defined in
the RM Plan.
46 hazardous situations were assessed in the product Risk Assessment document. The
summary of hazards prior to, and after the implementation of all the mitigation's are
provided below.
Risk Pre-Mitigation Hazards Post-Mitigation Hazards

Acceptability
Minor Serious Major Critic Minor Serious Major Critica
al l
Acceptable 5 0 3 0 11 6 24 5
Risk Mitigation 0 6 27 0 0 0 0 0
Required
Unacceptable 0 0 0 5 0 0 0 0
After mitigation, there are no unacceptable risk in the device.
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Risk Benefit Analysis and Overall Residual Risk Summary
As per the Standard ISO 14971, the benefit of the device is to achieve the intended clinical
performance. Based upon the risk assessment and objective evidence, the device is meeting
the intended uses as described below:
a. The benefit of any diagnostic imaging device is that it provides a visual means to determine
a patient’s anatomical condition. It allows for visual confirmation and hence, when
necessary, a guidance for treatment, for the intended uses. Diagnostic imaging introduces
little or no significant risk to a patient when trained and experienced clinicians use them.
b. The benefit analysis against individual and overall residual risk is evaluated following the
standard ISO 14971 and accordingly conducting the Product Risk Assessment. It is further
supported by more detailed engineering documents, such as engineering specifications and
V&V. There are no new unmitigated risks due to the combined effects of identified
hazardous situations and their mitigation's.
c. Experts from different functions (Engineering, Quality, Manufacturing, Service etc.)
participated, reviewed, and approved the risk management files. Labeling with proper
information for safety and the disclosure of residual risks has been reviewed and approved.
The combined risk for the product is deemed acceptable.
d. Clinical Evaluation demonstrates the safety and clinical performance as shown in the Clinical
Evaluation Report and related documents.
e. All the hazards/hazardous situations and associated risks have been evaluated; mitigated
and documented. The effectiveness of the risk control measures was determined to reduce
each residual risk to an acceptable level. Individual risks identified in the risk processes are
documented in the Risk Assessment document. The product risk management team
determined there are no unacceptable residual risks.
All Design reviews have been successfully conducted. Review and approval of the design has
been achieved through the design control procedure, to ensure the proper product design
and implementation. It is concluded by the Risk Management project team that the product's
benefit associated with the intended use outweighs the individual and overall/combined
residual risks. Hence, the product’s overall residual risk is acceptable for the intended use.
Disclosure of Residual Risks/Side-Effects
There were no risks identified in the the risk management process that requires escalation
to the clinical evaluation in order to support the requirements related to safety or side
effects.
The product user manual discloses the X-Ray as a residual risk that is inherent with the use
of X-Ray technology. It is disclosed to Users, so they can make proper decisions regarding
the use of the device and to take appropriate protective actions. It corresponds to Hazardous
situation ID HZ-02,03,04,05,08,09,10,11&13 [R5] .
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4. Equivalence
Clinical data to support safety and performance of the device under evaluation can be derived from equivalent devices.
6.1 Equivalent devices:
The following devices are considered equivalent to the devices listed in this report:
 BPL HRAD 32, BPL

 Model - MX 32 HF Medion Health care
 MULTIX Impact Siemens HealthCare
The analysis and conclusions were identified in below table as:
 Same: No difference in characteristics between products

 Similar: No Clinical significant difference in the performance and safety of the device would be triggered by the differences between the device under
evaluation and the device presumed to be equivalent
 Different: Difference in characteristics between products does not meet the definition of similar
HF-400 BPL HRAD 32 Model - MX 32 HF MULTIX Impact Analysis and

Conclusion
Manufacturer Saakshi Medtech and BPL Medical Medion Health care Siemens
Panels Limited technologies HealthCare
(Erstwhile SAAKSHI
MACHINE AND TOOLS
PVT.LTD.)
Clinical Characteristics
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Intended use The HF 400 system is BPL’s fixed X-ray MX 32 HF is intendedMultix Imapact is Same: No difference in
intended for taking X- system is designed to for taking X-rayintended for taking characteristics
ray examinations address imaging examinations whichX-ray examinations between products
which can be coupled needs in all clinical can be coupled withwhich can be
with any other settings. It enables any other solutions forcoupled with any
solutions for a medical imaging of skull, a medical diagnosis ofother solutions for
diagnosis of various chest, extremities, various humana medical diagnosis
human diseases or spine and abdomen, diseases or injuries. of various human
injuries. and choice of diseases or injuries.
diagnostic bucky
tables.
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Clinical The HF 400 system can The BPL HRAD 32 The MX HF32 systemMultix Impact Same: No difference in
Applications be used for routine X- system can be used can be used for routinesystem can be used characteristics
ray examinations on for routine X-ray X-ray examinations onfor routine X-ray between products
patients in the examinations on patients in theexaminations on
standing, seated or patients in the standing, seated orpatients in the
lying positions. This standing, seated or lying positions. Thisstanding, seated or
includes standard lying positions. This includes standardlying positions. This
radiography includes standard radiography includes standard
procedures such as:  radiography procedures such as: radiography
X-ray examinations of procedures such as:  X-ray examinations ofprocedures such as:
the skeleton including X-ray examinations the skeleton including X-ray
skull, ribs, spine, of the skeleton skull, ribs, spine,examinations of the
pelvis, upper including skull, ribs, pelvis, upperskeleton including
extremities, lower spine, pelvis, upper extremities, lowerskull, ribs, spine,
extremities, etc.  X- extremities, lower extremities, etc.  X-pelvis, upper
ray examinations of extremities, etc.  X- ray examinations ofextremities, lower
the lung or chest  X- ray examinations of the lung or chest  X-extremities, etc. 
ray examinations of the lung or chest  X- ray examinations ofX-ray examinations
soft tissue such as ray examinations of soft tissue such asof the lung or chest
abdomen  Trauma soft tissue such as abdomen  Trauma X-ray
cases abdomen  Trauma cases examinations of
cases soft tissue such as
abdomen  Trauma
cases
Technical Characteristics
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Type of High Frequency, 32 High Frequency, 32 High Frequency, 32 kWHigh Frequency, 55 Similar: No Clinical
Generator : kW kW kW significant difference
in the performance
and safety of the
device would be
triggered by the
differences between
the device under
evaluation and the
device presumed to be
equivalent
Type of Control Digital Digital Digital Digital Same: No difference in

Console characteristics
between products
Input Supply 200-240V, 50/60 Hz 1 230 V, 50 Hz 1 Phase 230 V, 50 Hz, 1 Phase 220-240 V, 50/60 Same: No difference in
Phase Hz, 1 and 3 pase characteristics
between products
Power Output 32kW 32 kW 32 kW 55 kW Similar: No Clinical

significant difference
in the performance
and safety of the
device would be
triggered by the
differences between
the device under
evaluation and the
14
equivalent
Maximum kV 125 kV 125 kV 125 kV 150 kV Similar: No Clinical
Output :- significant difference
in the performance
and safety of the
device would be
triggered by the
differences between
the device under
evaluation and the
equivalent
Maximum mA 400 mA 400 mA 400 mA 550 mA Similar: No Clinical
Output :- significant difference
in the performance
and safety of the
device would be
triggered by the
differences between
the device under
evaluation and the
equivalent
Maximum 10 Sec 10 Sec 10 Sec 15 Sec Similar: No Clinical
Timer :- significant difference
in the performance
and safety of the
device would be
triggered by the
15
differences between
the device under
evaluation and the
equivalent
No. Of X-Ray Single Single Single Single Same: No difference in
Tube :- characteristics
between products
Patient Table :- Manual Multiposition Manual Manual Multiposition Automatic table Similar: No Clinical
Multiposition floating significant difference
in the performance
and safety of the
device would be
triggered by the
differences between
the device under
evaluation and the
equivalent
Cassette All cassettes with a All cassettes with a All cassettes with aAll cassettes with a Same: No difference in
format of up to 5" x 7" format of up to 5" x format of up to 5" x 7"format of up to 5" x characteristics
to 14" x 17" either 7" to 14" x 17" either to 14" x 17" either7" to 14" x 17" between products
upright (portrait) or upright (portrait) or upright (portrait) oreither upright
sideways (landscape). sideways (landscape) sideways (landscape) (portrait) or
sideways
(landscape)
Environmental Operation Operation Operation Operation Same: No difference in
Conditions: Temperature: +10 °C Temperature: +10 °C Temperature: +10 °C toTemperature: +10 characteristics
to + 40 °C; Operation to + 40 °C; Operation + 40 °C; Operation°C to + 40 °C; between products
16
Relative Humidity: Relative Humidity: Relative Humidity: 30%Operation Relative

30% to 75% non- 30% to 75% non- to 75% non-Humidity: 30% to
condensing; condensing; condensing; Operation75% non-
Operation Operation Atmospheric Pressure:condensing;
Atmospheric Pressure: Atmospheric 500 to 1060 hPa Operation
500 to 1060 hPa Pressure: 500 to Atmospheric
1060 hPa Pressure: 500 to
1060 hPa
List of IS 7620 IS 7620 IS 7620 IS 7620 Similar: No Clinical
standards and IEC 60601-1 AERB AERB IEC 60601-1 significant difference
regulatory IEC 60601-2 CDSCO CDSCO IEC 60601-2 in the performance
requirements AERB AERB and safety of the
CDSCO CDSCO device would be
triggered by the
differences between
the device under
evaluation and the
equivalent.
Biological Characteris
17
Patient Body Only the surfaces of Only the surfaces of Only the surfaces ofOnly the surfaces of Same: No difference in
Contact the X-ray system will the X-ray system will the X-ray system willthe X-ray system characteristics
come in contact with come in contact with come in contact withwill come in contact between products
patient body. patient body. patient body. with patient body.
Considering above table it s is obvious that the selected equivalent devices are directly compared with the medical device under consideration.
18
DOC ID: HF 400 CED/01
Clinical Evaluation Report of HF-400 Date: 05-Aug-2023
SAAKSHI MEDTECH AND PANELS LIMITED
(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)
5. Data Selection and considerations

In order to present a clinical evaluation, all data generated and held by manufacturer with relation to the devices have been considered in the clinical
safety and performance assessment. This includes all the following:
 Pre clinical data

 Literature and published reports
Each data set has been appraised and weighted for relevance and contributing to confirming compliance with requirements. A detailed description
of literature search protocol as well as the appraisal and weighing criteria are detailed in below chapters.
The clinical evaluation was based on the following elements
Data type Description Justification Data Source

Preclinical Verification Provides SOP for Installation & Testing (SOP/TESTING/HF-
Data Testing data data related 400/01) is reviewed and verified for inhouse
and to device intallation & FQC testing for each and every unit.
Validation safety and
Testing Data performance IEC Test reports- IEC 60601-1, IEC 60601-2-54
IFU user manual is available (F/DOC/35) Standard

operating procedure for Radiation Protection and
Safety is available (SOP/TESTING/HF-400/02),
Radiation tube housing leakage test is done and
available in FQC (SMTPL/FQC/HF 400/01),

Radiation protective accessories is Tested,

Radiological output Test is done and point
available in FQC (SMTPL/FQC/HF 400/01), All
radiation related test is performed by traind per
who is qualify from Bhabha Atomic Research
Centre (QA-DXE Course)
Scientific Articles Scientific The search protocol and reports will be
literature published in literature documented in separate document and referred to
scientific provides in the CER
journals current
clinical data
that has
been peer
reviewed
Adverse Adverse Adverse CDSCO and MAUDE Database, the results will be
event data events of events are documented in the below chapters
equivalent real world
devices market
experience
data

6. Summary and appraisal of clinical data
6.1 Verfication and Validation activities

SOP for Installation & Testing (SOP/TESTING/HF-400/01) is reviewed and verified for in house intallation & FQC testing for each and every unit.
IFU user manual is available (F/DOC/35) Standard operating procedure for Radiation Protection and Safety is available (SOP/TESTING/HF-400/02),
Radiation tube housing leakage test is done and available in FQC (SMTPL/FQC/HF 400/01), Radiation protective accessories is Tested, Radiological
output Test is done and point available in FQC (SMTPL/FQC/HF 400/01), All radiation related test is performed by trained person who is qualify from
Bhabha Atomic Research Centre (QA-DXE Course).
Following are reports of Design verification and validation activities of HF- 400:
R6. Design Output Verification HF 400 SMTPL/DV/HF 400/01

R7. Product Regulatory Test cum Validation Report F/T/-O/01
REV/Date: 00/01/02/2023
R8. BIS Certification Marks Licence BIS License no: CM/l-
3963176
R8. Atomic Energy Regulatory Board, Government of Doc No. 23-TA-945236
India Product Type Approval: Issuance Date:
26/05/2023 and Expiry Date:26/05/2026
The above documents provides verification and validation of both performance and safety of the device under evaluation.

6.2 Internal Vigilance Data

There are no complaints, CAPAs or SCARs yet associated with the device HF-400.
6.3 State of the art
. The device has been manufactured according to the Quality Management Manual of Saakshi [R2]. The scope of the Quality management
system is “DESIGN, MANUFACTURING & SUPPLY OF X-RAY EQUIPMENT”. The quality system manual is certified according to ISO 13485:2016.
Furthermore, the device is developed according to following Standards:
 IS 7620
 IEC 60601-1
 IEC 60601-2-54
 AERB (Manufacturing License & Product type Approval)
 CDSCO
 ISO 14971
The HF 400 system is not considered as novel technology and are purely based on well established diagnostic X-ray imaging technologies.
Radiography with X-ray devices, based on comparable technology is established for medical diagnosis of various human diseases or injuries for mor
than 50 years. A review of the current knowledge/the state of the art is needed for the proper conduct of the appraisal and analysis of the clinical data
of the device under evaluation and the equivalent device. The data used within this section is based on a clinical practice guideline/parameter and
technical standards. This record covers identification of medical fields concerned to include relevant medical conditions and alternative treatments.
Furthermore, it identifies and analyses currently available devices that target the same conditions and populations.
The chosen sources of information and data for the state of the art report are the American College of Radiology’s (ACR) Practice Parameters and
ACR Appropriateness Criteria documents, which are published by ACR on their website (https://www.acr.org/Clinical-Resources/Practice-Parameters-
and-Technical-Standards/Practice-Parameters-by-Modality) and (https://acsearch.acr.org/list), respectively.
Through the description of particular training, abilities, and procedures, the ACR Practise Parameters and Technical Standards enhance the safe and

efficient use of diagnostic and therapeutic radiography.
Practise Parameters outline the required behaviour in particular clinical practise settings. They are based on reviews of recent research, professional
judgement, comments from public forums, and formal consensus. Practise Parameters may be changed in accordance with unique circumstances
and available resources because they are not meant to be legal standards of care or behaviour.
The Commission on Quality and Safety, the ACR Board of Chancellors, the ACR Council Steering Committee, and the ACR Council all had to give
their approval before any practise parameter or technical standard, which serves as a statement of policy by the College, could be implemented.
To promote the field of radiology and raise the standard of care provided to patients across the country, the American College of Radiology will on
occasion define new practise criteria and technical requirements for radiologic practise. On their fifth anniversary or earlier, if indicated, existing
practise guidelines and technical standards shall be examined for adjustment or renewal, as needed.
The ACR collaborated with societies in each of the sub-specialty fields to create the Practise Performance documents. The following Societies
collaborated with the ACR in the production of the Practise Parameters documents:
• the American Society of Emergency Radiology (ASER),

• the Society of Computed Body Tomography and Magnetic Resonance (SCBT-MR),
• the Society for Pediatric Radiology (SPR),
• the American Society of Neuroradiology (ASNR)
• the North American Society of Cardiovascular Imaging (NASCI)
• the Society of Thoracic Radiology (STR)
• the Society of Skeletal Radiology (SSR)
• the American Society of Spine Radiology (ASSR),

• the American Association of Physicists in Medicine (AAPM),

• the Society of Abdominal Radiology (SAR)
The ACR Appropriateness Criteria® (AC) are evidence-based guidelines to assist referring physicians and other providers in making the most
appropriate imaging or treatment decision for a specific clinical condition. Employing these guidelines helps providers enhance quality of care and
contribute to the most efficacious use of radiology.
Rationale of choosing the data source

ACR Select covers over 1,000 individual imaging CPT codes and contains over 15,000 individual Appropriate Use Criteria covering all of medical
imaging, and has been adapted by medical professionals across the globe including India. The American College of Radiology produced the
recommendations that served as the foundation for the ESR iGuide over a 25-year period, drawing on the knowledge of thousands of volunteer doctors
who served on 12 expert panels to evaluate approximately 6,500 peer-reviewed papers.
The ACR has published, for public access, on their website under Clinical Resources, Practice Parameters by Modality: https://www.acr.org/Clinical-
Resources/Practice-Parameters-and-Technical-Standards/Practice-Parameters-by-Modality
The ACR has published Practice and performance Parameter guidance documents for different body areas for radiography as an imaging modality.
The Practice parameters are based on analysis of current literature, expert opinion, open forum commentary and formal consensus.
For these reasons, we decided to use information from the American College of Radiology.
Moreover, X-ray Radiography provides images of human internal organs this has no differences irrespective to populations across the globe.
Therefore, the data source choosen is considered appropriate for evaluation of HF-400 device, manufactured in India.
6.3.1 Background
Radiography is a tried-and-true technique that assesses human anatomy and disease using variations in X-ray attenuation. The objectives are to
verify the existence or absence of illness, ascertain its aetiology, and, where clinically justified, track its progression. Radiation exposure should be
kept to a minimum while the investigation is carried out using a radiation dose that maximizes image diagnostic data. To ensure the safety of the

examination, it should only be carried out under the direction of a doctor who has received the required radiation protection training.
6.3.2 Technology
Radiography is a projectional x-ray-based technology that is frequently used in modern medicine to acquire images quickly for a wide range of reasons.
Radiography makes use of variations in electron density to provide contrast between various tissues, including bone. Although far less sensitive than
dual X-ray absorptiometry, x-rays may nevertheless identify demineralized bone.
6.3.3 Radiation Safety in Imaging

Keeping radiation exposure to staff and society at large "as low as reasonably achievable" (ALARA) and ensuring that radiation doses to specific
patients are appropriate while taking into account the potential risk from radiation exposure and the diagnostic image quality required to achieve are
two things that radiologists, medical physicists, registered radiologist assistants, radiologic technologists, and all supervising physicians have a
responsibility for safety in the workplace. The fundamentals of both occupational and public radiation protection must be understood by all individuals
who operate with ionising radiation.
Every time it makes sense, imaging equipment's automated dosage reduction solutions should be applied. In the absence of such technology, suitable
manual approaches ought to be applied. Facilities that provide radiography should be mindful of radiation exposure to children and follow patient-
appropriate, size-based guidelines, as those recommended by Image Gently or AERB.
6.3.4 Alternative imaging modalities to radiography: CT, Ultrasound and MRI

This section provides a description of the different medical imaging modalities beside radiography, such as CT, ultrasound and MRI and a brief
comparison of those imaging modalities.

Computed Tomography (CT)

Computed tomography is a cross-sectional x-ray technology that creates a cross-sectional picture using a tomographic method and computer
processing. Although CT has a lesser resolution than radiography, it is far more sensitive to minute variations in electron density and produces
images with noticeably better contrast. A typical clinical scanner is used to conduct quantitative CT (QCT), which is very precise in identifying the
tissue density in a specific area of interest. However, compared to dual X-ray absorptiometry, radiation exposure is significantly higher.
Ultrasound
Diagnostic ultrasonography is a non-ionizing radiation tool that creates picture contrast and contour by using the differential absorption of sound waves
by various tissues. Sound waves are used in quantitative ultrasonography of the calcaneus to assess bone health characteristics. Bone structure and
density attenuate sound waves. It has been demonstrated that higher attenuation occurs with increasing structural complexity. Contrarily, osteoporotic
bone exhibits slower velocities. The outpatient environment has made use of the compact, reasonably priced ultrasound machines. Quantitative
ultrasonography does not, however, evaluate bone mineral density, thus it may not be appropriate to use the World Health Organization's (WHO)
definition of osteoporosis.
Magnetic resonance imaging (MRI)
A powerful magnetic field is used in magnetic resonance imaging (MRI), a non-ionizing radiation technique, to produce pictures. Hydrogen protons
are excited by a radiofrequency pulse, and when they return to equilibrium, their microenvironment determines how quickly they do so. This results in
tissue contrast because protons in fat recover from an excited state more quickly than those in water. The method is incredibly sensitive to minute
variations in water and proton content, making it simple to identify pathologic conditions like edoema in vivo. MRI is less of a screening tool for most
clinical conditions and more of a targeted problem-solving tool because the imaging process is rather slow, the target region of interest is often tiny,
and the equipment is costly. Some implanted devices and metallic foreign entities are common MRI contraindications.

Comparison of the imaging modalities
When MRI cannot be used because of claustrophobia, technical difficulties (such as patient size), safety concerns (such as pacemaker), or when MRI
is insufficient to distinguish congenital anomalies (such as diastematomyelia), radiography is advised. Alternative imaging techniques that do not
subject the patient to ionising radiation include MRI and ultrasound. The brain, spine, and musculoskeletal system respond well to magnetic resonance
imaging. If the region of clinical interest is reachable by the ultrasonic probe from the skin surface, ultrasonography is also effective for imaging the
non-bony components of the musculoskeletal system, soft tissues, and vascular structures.
When radiography or CT would otherwise subject the patient to pelvic radiation, ultrasound is especially helpful for children and women who are of
childbearing age. This is especially crucial during pregnancy. MRI is the best modality for evaluating pregnant patients due to its excellent
representation of a wide variety of disease processes and safety due to the absence of radiation.
Although ultrasonography is a similarly safe imaging technique, it is less accurate at showing maternal acute illness processes outside of the uterus
and adnexa and is unable to offer a topographical view of the entire body. In addition to showing complicated congenital disorders, MRI is a crucial
supplement to ultrasonography. In comparison to CT, radiography exposes the patient to less radiation.
Additionally, MRI can be thought of as a substitute for CT in some patient populations, such as pregnant women (noncontrast MRI), children, and
those who have had several prior CT scans. Ultrasonography is the first-choice imaging modality where ionising radiation is a particular concern.
6.3.5 Comparision of the imaging modalities according to anatomical locations based on ACR appropriateness Criteria®
The purpose of this section is to examine the suitability of various imaging modalities for various reasons based on anatomical locations, including

radiography, CT, MRI, and ultrasound.
Chest and thorax
Neoplasm staging may benefit from chest radiography. As part of normal restaging or when there is a clinical suspicion of disease return or progression,
chest radiography should not take the place of chest CT, nevertheless. Studies indicate that, despite the chest radiograph's limited sensitivity, which
may miss 50% of rib fractures, failure to find fractures does not always affect how patients are managed or how their cases turn out in straightforward
situations. The chest radiograph may pick up consequences like pneumothorax, hemothorax, flail chest, or contusion that are more significant than
the rib fractures itself.
Although it is often employed for injury evaluation in the context of severe trauma, CT is more sensitive than radiography for the diagnosis of rib
fractures. For patients with high-mechanism traumatic chest trauma, chest radiography and chest CT/CT angiography are complimentary first-line
imaging modalities.
Abdomen
A radiograph could be used to support that conclusion or to yield other conclusions, such as the identification of a palpable tumour and intestinal
blockage. Nevertheless, radiography is advised in certain situations following CT, MRI, and ultrasound. Due to its nonionizing nature, ultrasonography
may be useful for diagnosing paediatric patients with palpable masses and necrotizing enterocolitis. MRI will come next if the ultrasound result is
unclear. Immediate cross-sectional imaging, especially CT, should be taken into account in individuals for whom a high clinical suspicion is present.
Along with FAST scanning and kidney-ureter-bladder abdominal radiography, examination with chest radiographs is frequently necessary for
hemodynamically unstable patients presenting with acute abdominal injuries.
Urinary tract

A restricted excretory urography may be recommended in some situations for the pregnant or potentially pregnant patient presenting with acute
abdominal discomfort. A restricted excretory urography could be preferred over a low-dose CT or MR.
The suggested imaging procedures for a suspected lower urinary tract damage resulting from blunt abdominal, pelvic, or perineal trauma are X-ray
retrograde cystography or pelvic CT with bladder contrast (CT cystography).
Noncontrast CT is frequently carried out when urolithiasis or renal colic is suspected. When it comes to identifying stones, finding signs of ureteral
blockage, and other possible causes of flank discomfort, it is quite accurate. Radiation exposure to the patient is noncontrast CT's main drawback.
The combination of abdomen and pelvis radiography and ultrasound may be a suitable and lower-radiation option for the detection of clinically relevant
stones in patients with known urolithiasis and/or a presentation typical for renal colic. MRI is a great technique for assessing hydronephrosis but has
a limited capacity to find tiny stones.
Plain radiography of the abdomen and pelvis may be helpful in individuals who have a history of kidney stones to examine stone size and location as
well as stone passage. However, during the first examination of hematuria, plain radiography of the abdomen and pelvis as well as catheter
arteriography of the kidneys are not employed as first line imaging modalities. Most individuals with gross or chronic microhematuria need a CT
urogram for urinary tract imaging.
Although MRI is a superior method for examining the renal parenchyma for masses and other abnormalities, CT urography and excretory urography
are superior to it for detecting tiny stones and urothelial diseases. Ultrasound is beneficial for locating renal calculi and renal masses in radiation-
sensitive groups, such as youngsters and women who are pregnant or child-bearing age. The initial suggested imaging modalities for a suspected
lower urinary tract damage resulting from forceful trauma to the lower abdomen or pelvis are pelvic CT with bladder contrast (CT cystography) or X-
ray retrograde cystography.

Gynecology
In order to assess the ovaries, uterus, fallopian tubes, and adnexa, transvaginal ultrasound is helpful. Additionally, it is inexpensive, easily accessible,
and free of ionising radiation. Both pelvic ultrasonography and MRI can be helpful in identifying endometriosis in women who have a history of the
condition or a clinical suspicion of it. When doing an infertility workup on these ladies, hysterosalpingography is also suitable. It is the type of imaging
that is most frequently used for women who may have tubal blockage. The poor soft-tissue contrast resolution of the uterus makes it difficult to
characterise the uterine architecture, making CT largely unwarranted for gynecologic operations like assessing vaginal haemorrhage.
Spine
The first line of imaging for assessing the spine and the preferred imaging method for children under the age of 14 has traditionally been radiography.
The preferred method for examining individuals suspected of having a spinal cord injury or experiencing cord compression, as well as for examining
patients who are obtunded, is magnetic resonance imaging (MRI).
Bone
The radiographic skeletal survey is the primary imaging test for identifying fractures in the field of paediatric trauma. The best initial test for assessment
is radiography in cases of acute hip pain with a suspected fracture. The function of US is not yet obvious, although second-line modalities like bone
scintigraphy and CT are. The primary and most common imaging modality used to assess shoulder arthroplasty, traumatic shoulder discomfort, and
acute wrist, hand, or finger injuries is radiography.
When compared to radiography, CT is more effective in identifying fracture patterns. However, radiographs are favoured over CT for first examination
because they may identify the main issues in the initial assessment of shoulder trauma—displaced fractures and shoulder malalignment. However,
MRI, which is regarded as being better than CT in this instance, is the best method for evaluating soft-tissue injuries, including meniscal injuries,
chondral surface injuries, and ligamentous disruption.

6.3.6 Detailed Indications for radiography according to ACR Appropriateness Criteria

Making the most suitable imaging or therapy decisions for a particular clinical condition is made easier with the help of the ACR Appropriateness
Criteria®. The appropriateness rate is divided into three categories in the ACR Practise Parameter:
"Usually appropriate": when the advantages of a therapy or treatment exceed the dangers or negative effects.
"May be appropriate" if the evidence is conflicting or unclear, the risks and benefits are ambiguous or uncertain, the individual ratings from the panel
rating are widely scattered, or there are unique circumstances or subpopulations that could affect the risks or benefits that are included in the variant.
"Usually not appropriate" means that the risks of the operation or therapy outweigh its advantages.
According to the ACR Appropriateness Criteria®, radiography is "Usually appropriate," "May be appropriate," or "Usually not appropriate" in the
different applications and indications listed below, along with any related contraindications. Consult the ACR Appropriateness Criteria® for more
information in detail.
The table below lists the various areas of application and indications for radiography, when it is considered as “Usually appropriate”, “May be
appropriate” or “Usually not appropriate” according to the ACR Appropriateness Criteria®, and any contraindications associated with the procedure.
For detailed information, refer to the ACR Appropriateness Criteria®
Please refer to appendix Table for details.
6.3.7. Considerations for certain populations Pediatric

It is especially crucial to design radiography tests to reduce exposure while yet delivering diagnostically sound examinations for children since they
are more susceptible than adults to the effects of ionising radiation. Radiography should occasionally be replaced with nonionizing imaging procedures
like ultrasound and MRI when suitable. There are several benefits of radiography over MRI, including the availability of CT scans, their superior spatial
resolution, their quicker examination times, their reduced need for sedation, and the absence of MRI-related contraindications.

Digital radiography should be carried out with the least amount of radiation exposure to the patient possible while yet meeting picture quality standards,
as is the case with all imaging tests using ionising radiation. Because they are more susceptible to ionising radiation than adults, paediatric patients
require specific care when being imaged.
The likelihood of unacceptably high quantum noise is increased, nevertheless, when exposure is reduced without first evaluating image quality.
Additionally, the degree to which the digital system is optimised for paediatric imaging and the type of the specific illness being detected determine
the required reduction in exposure to the image receptor. It is crucial that the technician put up persistent commitment and effort to reduce exposure
in paediatric imaging. Digital radiography poses particular difficulties for imaging paediatric patients. The size of patients might range from a newborn
to a young adult, necessitating the use of a variety of radiographic method elements. Due to the smaller body components, paediatric imaging requires
a greater level of spatial resolution.
The clinical application of AEC in paediatric patients presents extra difficulties since the tiny size of the paediatric organs may only partially cover the
AEC cells, artificially reducing the radiography exposure.
Pregnant or Potentially Pregnant Adolescents and Women

Medical imaging procedures that expose pregnant or potentially pregnant patients to radiation and how these patients should be managed are
complicated subjects. It is understandable that patients, their families, radiologists, doctors, and other medical professionals who refer patients for
imaging treatments or conduct imaging in their own offices are worried about potential radiation damage to the growing embryo and foetus.
The possible hazards to a pregnant patient who refuses to undergo a necessary imaging treatment due to unwarranted or excessive radiation anxiety
are also a cause for worry. Clearly, to appropriately care for the sick or wounded pregnant patient, an appropriate benefit/risk viewpoint is required.
Many routine imaging techniques do not need pregnancy confirmation. However, in some circumstances, the clinical history should be sought to
determine the pregnancy status before carrying out ionising imaging tests that might expose the conceptus.
Generally speaking, the pregnancy status is not required for x-ray-based exams that do not expose the pelvic or gravid uterus directly to the x-ray
beam.

A. Chest radiography during the first and second trimesters is one of these investigations, although it is not the only one.
B. Extremity radiography or CT (except from the abdomen or pelvis, with the hip conceivably an exception).
C. Any diagnostic head-or neck-related exam
D. Mammography
Here are several tests that might not need to confirm whether a woman is pregnant:
a. Abdominal or pelvic interventional fluoroscopic procedures
b. Diagnostic pelvic or abdominal angiography
c. Hysterosalpingography
d. Abdomen or pelvis standard-dose CT regimens
e. Diagnostic Nuclear Medicine PET/CT
The radiologist or nuclear medicine doctor should consult a qualified medical physicist to estimate the absorbed dose to the conceptus from the
diagnostic or interventional procedures, either prospectively or retrospectively, when managing a pregnant patient who may have received a high dose
of radiation. The radiologist should also seek the qualified medical physicist's advice on ways to fairly reduce risk.
There has been a claim that there is "no safe level" of radiation exposure since some radiation impacts (stochastic effects) lack a generally accepted
threshold. "No safe level" is a broad generalisation that is frequently used without supporting scientific data and should only be used when an activity
or intervention has no value. When the advantages of an activity vastly outweigh the risks, it is not relevant.
Furthermore, because of the radioactivity of our planet, certain regions have higher levels of background radiation than others. More people than
others are exposed to ambient radiation that is present naturally. This includes those who often fly by air and those who reside at high altitudes. These
actions are seen to be advantageous to their way of life. Due to the additional radiation that arises, neither of these conditions is seen to be naturally
hazardous.

The term "safe" should always be used in the context of benefit vs risk, whether it is used in a clinical or nonclinical situation. Taking the proper steps
to reduce the risk to a level that is well-justified by the reward is the key to safety. The degree of medical value should outweigh the carefully controlled
levels of risk in order to maintain a high standard of safety, especially when imaging patients who might be pregnant.
6.3.8. Conclusion
The evidence presented here demonstrates that radiography is a modality that is state-of-the-art for diagnostic imaging and that it is deemed to be
"Usually Appropriate" according to the ACR Appropriateness Criteria® for a number of indications, suggesting that the benefits of undergoing the
procedure or treatment outweigh the risks or harms. The use of radiography for imaging has no strict limitations. Prior to doing radiography, like with
any operations, the relative advantages and hazards of the procedure should be assessed. To reduce patient hazards, such as radiation exposure,
appropriate measures should be implemented.
6.4 Scientific literature data

The search protocol, Search workbook and search report is documented in a separate document.
The literature search report documents the protocol, appraisal and results of literature search to identify the clinical data that is not held by the
manufacturer but may assist in clinical evaluation of safety and performance of HF-400 System. This document provides the record of literature
search performed, evaluation of methods used, verification of the results and parameters for the search to be reproduced.
Following are the results of literature review:
152:
A published study by Zeng GL et, al. Titled “Anterior Talofibular Ligament All-Inside Arthroscopic Reconstruction with InternalBrace™ for Chronic
Lateral Ankle Instability” has used SIEMENS MULTIX Impact for radiographic evaluation in their study of retrospective evaluation of feasibility and
safety of InternalBrace™ reconstruction treatment of anterior talofibular ligament under total arthroscopy for CLAI patients, and analyzed its clinical
effects , clinical data of 108 patients randomly selected in the Dongguan Hospital of Traditional Chinese Medicine, over a period of 2 years. Inclusion
criteria were: age 19–58 years, repeated painful ankle sprains and failure to respond to conservative treatment for 6 months, unstable walking, and
limited sensorimotor function. Following radiographs of Leg, Foot and ankle were taken using Multix impact. All-inside ATFL reconstruction with an
InternalBrace™ under arthroscopy has significant superiority in ankle stability after surgery which allows early rehabilitation, and can restore the
ankle function and satisfy the need for sports function in Chronic Lateral Ankle Instability.
156:
Yan R et al , in their study titled “ One-Stage Closed Intramedullary Nailing for Delayed Femoral Fracture in Multiple Injured Patients.”, which was a
retrospective study conducted on delayed femoral shaft fracture , where multiple injured patients aged from 18 to 60 years with delayed femoral
fracture and treated by one-stage internal fixation technique, were included. They have used Siemens, MULTIX Impact, for pre operative evaluation
of the fracture site. This study aimed to investigate: (i) whether the closed reduction can be acquired by the unilateral extendable external fixator
in delayed femoral fracture; (ii) whether the one-stage closed intramedullary nailing can be carried out effectively for patients; (iii) the clinical effects
and functional recovery of this technique. Their results showed that: (i) the unilateral extendable external fixator could provide sufficient mechanical
distraction strength for the shortened delayed femoral fractures; (ii) the fixator-assisted nailing technique could achieve good closed reduction for
most cases; (iii) the one-stage protocol could promote the fracture union and have low complication rate with satisfactory functional recovery. They
conclude that one-stage fixator-assisted nailing provides a minimally invasive strategy for most of the patients safely and restores the extremity
length, thus it is a useful and effective technique.
157:
A study by Ruijian Yan, et al, “A Novel Suture-Preset Spring Plate System (SSPS) for Comminuted Coronoid Process Fracture in the Elbow”, which
was a retrospective study carried out in the patients with comminuted fractures of the coronoid treated by this novel method , SPSS fixation .A
total of 17 patients (17 sides) were included in their study, including 11 male and six female, with a mean age range from 18 to 60 years. They have
utilised x-ray Siemens, MULTIX Impact radiography instrument in their study for pre operative elbow fracture assessment. Their results gave
supportive evidence for this novel method , during the immediate post operative and follow up periods. Hence , they concluded that the SSPS
method can provide a reliable fixation for the comminuted coronoid fracture with satisfactory clinical outcome.

160:
A study titled “Safety and Functional Integrity of CGM Sensors When Used During Radiologic Procedures Under High Exposure Conditions “ by
William Matievich et al. Sensors were loaded with simulated glucose data and exposed to X-ray scanning, computed tomography (CT), and magnetic
resonance imaging (MRI) to simulate radiotherapeutic procedures. A Siemens Multix QDR SERIES X-ray scanner (Siemens, Munich) was used for X-
ray exposure evaluations. They found that all sensors passed all acceptance criteria following each session of X-ray, CT, and MRI exposures. Hence
, they could conclude that the sensors maintained functionality following a series of high exposure conditions in both X-ray and CT scanning systems,
and the sensors were easily visible and identifiable when scanned using clinically relevant scanning parameters.
170:
Alzyoud K et al did a study by name “Supine and erect abdominal radiography: A comparison of radiation dose and image quality.” The aim of this
study was to compare erect and supine projections in terms of radiation dose and image quality. Body mass index (BMI), sagittal body thickness,
dose area product (DAP)and effective dose (ED) data were collected for 81 patients referred for digital abdominal radiography in both the supine
and erect positions. Image quality was assessed by both visual and quantitative methods. The estimated ED in the erect position was 102% higher
compared to the supine position. The mean ± SD visual image quality was reduced (27%) when using an erect position 1.9 ± 0.5 when compared
with supine 2.6 ± 0.7. The calculated signal to noise ratio (SNR) was higher in erect position by 14%. Contrast to noise ratio (CNR) was reduced by
16% when using an erect position. A single projection is likely to be sufficient but in certain situations, for example in case of absence of a computed
tomography (CT) scanner or ultrasound, then an additional erect abdominal radiograph may be warranted. The erect abdomen radiograph increases
the radiation dose and decreases the image quality. Their study findings support the continued use of the supine position as the preferred method
due to significant reductions in radiation dose when compared to erect imaging.
175:
“Comparison of Physical Therapy and Mulligan Mobilization Technique in the Treatment of Cervicogenic Headache” a study by Mine Argali Deniz et
al. The aim of this investigate the effectiveness of the conventional physical therapy and Mulligan mobilization technique in the treatment of
Cervicogenic Headache (CH) and to compare the effectiveness of these two methods. A total of 40 patients with CH were studied. For neck lordosis

angle, lateral radiographs were taken with Siemens Multix digital radiography device (Siemens AG Healthcare Sector, Erlangen, German) was used
in this study.
Neck Disability Index and Beck Depression Scale decreased and restriction of movements, ROM, cervical performance and lordosis angle increased
significantly in both groups. They found that both treatments were found to have positive effects on radiological and clinical findings of CH, but
Mulligan mobilization technique was found to be more effective in all evaluations except neck extension and right lateral flexion ROM
measurements.
178:
DEXIN ZOU et al, in a study with title” Evaluation of the clinical efficacy of the bilateral pedicle cement anchoring technique in percutaneous
vertebroplasty for Kümmell disease .“ Their study aimed to evaluate the clinical efficacy of the bilateral pedicle cement anchoring technique
combined with the postural reduction in percutaneous vertebroplasty (PVP) for Kümmell disease. Pre- and post-operative bone mineral density,
injected cement volume, visual analogue scale (VAS) values, Oswestry disability index (ODI) scores, Cobb angle measurements and anterior vertebral
height (AVH) were recorded and assessed. Siemens Multix Fusion radiograph instrument was used to evaluate these parameters. The results showed
, the treatment of Kümmell disease with PVP, the bilateral pedicle cement anchoring technique combined with postural reduction can achieve good
clinical outcomes and the changes in the Cobb angle and AVH before and after surgery were also statistically significant in the radiological
evaluation.
179:
“Reference Levels of Radiation Dose for Imaging in Pediatrics “, a study by Lina et al, carried out to show the Dose Reference Levels (DRLs) used in
the institution to which the authors belong, in the CT, radiography and fluoroscopy modalities and to compare them with international standards.
This was a retrospective descriptive cross-sectional study. Multix MP from Siemens, equipped with a DAP (dose area product) dose meter was used
for this study. Reference levels of radiation dose used in the hospital were found to be low compared to European guidelines of 2018 reference
levels. DRLs are described for each study and age group. They concluded that at the hospital where the study was conducted, reference levels of
radiation in the pediatric population are low.

180:
”Are Automated and Visual Greulich and PyleBased Methods Applicable to Caucasian European Children With a Moroccan Ethnic Origin When
Assessing Bone Age?” , a study carried out by Grammatina Boitsios et al, to test the accuracy of the visual and automated bone age assessment base
on the Greulich and Pyle (GP) method in healthy Caucasian European children with a Moroccan ethnic origin. 423 Moroccan Caucasian (MC) children
were retrospectively studied, aged from 2 to 15 years with a normal left-hand radiograph performed to rule out a trauma. Dorso-palmar radiographs
of left hand to rule out a musculoskeletal trauma are acquired on a Siemens Multix TOP radiography. Visual bone age assessment was related to the
CA in both girls and boys . Automated bone age assessment was related to the CA in both girls . They concluded that Visual and automatic bone age
assessment based on the GP method, previously validated in the general population of Caucasian European children, can be confidently used in
healthy Caucasian European children with a Moroccan ethnic origin. Attention should be drawn assessing bone age in children during puberty where
a more significant variability in bone age determination is observed with both methods, particularly in Moroccan boys.
181
“HIGH-TECHNOLOGY MEDICAL EQUIPMENT MANAGEMENT: IMPLEMENTATION OF A MULTIDISCIPLINARY DOSSIER FOR HUMANITAS RESEARCH
HOSPITAL” a thesis submitted by ALBERTO FUMAGALLI et al. They have studied on , Siemens Multix Fusion Digital Radiography system, present in
Humanitas hospital. At the top the x-ray tube structure, while at the bottom and on the right the Flat Panel Detectors. The use of one or the other
depends on the body district to be imaged
The patient may be imaged from several angles. An x-ray session usually lasts about 10 minutes. Then, images could be either developed from an x-
ray film or written to a CD, depending on the used technique. Such as in the other x-ray-based devices, a contrast medium may be injected to the
patient. The advantages of these devices are their simplicity, low cost, sufficient image resolution for diagnosis purposes, good clinical efficacy, and
flexibility to the situations of use. Nevertheless, radiographic technique has numerous limitations and constraints. Just to list a few examples: the
fact that it provides a two-dimensional projection of a three-dimensional structure, thus losing depth information (limit overcome by CT
technologies); the fact that the geometry of the system could cause a low precision in the output, for example due to the presence of an enlargement
factor.

Training courses for internal technicians: this is one of the most important goal of this work. Installed software (“software installati”): pc installed
software. In this case it is necessary to distinguish the company's own software or traditional software; for instance, considering the Siemens RMNs,
all the system are based on Syngo, which is a Siemens software; while, considering Philips RMNs, they are based on a generic Windows version.
191
Igoh et al ., in their study, “Chest Radiography: A Review of 5 Year Findings in Peripheral Facilities in Jos, North -Central Nigeria. “ , with an objective
to review the chest radiographic findings in peripheral facilities in Jos North Central Nigeria over a period of five years. A five (5) year retrospective
review of the archive of chest radiographs referred from peripheral facilities. The study included 1039 females and 1482 males. The chest x-ray
examination was performed using a multix swing floor mount 500MAs X ray machine(Siemens, 2007 Germany) fitted with a chest stand and a
stationary grid. Chest x-ray was normal in 68.9% of the subjects while 783 (31.1%) patients showed various abnormal findings, like chest
infection(20.1%) and hypertensive heart disease (5.3%).Other findings include heart failure (1.5%), hypertension(1.5%),pleural effusion(1.0%) and
pulmonary tuberculosis (0.6%).The least findings were lung metastasis and rib fracture following road traffic accidents constituting 0.1% each. Their
study have concluded that ,multiple aetiologies are responsible for the request for chest Radiographic evaluation .Chest radiography is an effective,
cheap and complementary imaging tool in evaluating cardiovascular, respiratory and musculoskeletal systems.
202
Zhang, F et al, have published an article titled” Association of serum creatinine with aortic arch calcification in middle-aged and elderly adults: an
observational cross-sectional study from China.” have studied on 9741 participants were recruited from health examination program of Qinglong
Community of Changzhou city, Jiangsu Province, China. Aortic arch calcifcation (AAC) was assessed using postero-anterior chest X-ray examination
(Multix Select DR, Siemens, Germany). AAC evaluation was executed on the basis of the image in chest X-ray examination on an electronic medical
record by trained radiologists blinded to each participant’s information. They investigated the association of serum creatinine levels with prevalence
of aortic arch calcifcation (AAC) in a larger middle-aged and elderly Chinese population. Our data suggested serum creatinine levels are signifcantly
associated with AAC in female aged>45 years old. Their results indicated that the role of serum creatinine levels in AAC and CVD development

remains under recognised and undertreated in the general population. Thus, they concluded that AAC or asymptomatic CVD risk screening should
be given for female with increased serum creatinine levels, especially in individuals concomitant with other CVD risk factors.
LITERATURE REVIEW SUMMARY TABLE
Table 5 Literature review summary table
S.N STUDY TITLE OF STUDY AUTHOR PATIENT DETAILS TYPE OF REMARKS

O NUMB RADIOGRAPHY
ER
1 152 “Anterior Talofibular Ligament All- Zeng GL et, 108 patients of LEG, Assessment of arthroscopic reconstruction to
Inside Arthroscopic Reconstruction al. age 19-58 years visualise the brace & joint contour
with Internal Brace™ for Chronic included both ANKLE JOINT & improvement after the surgery.
Lateral Ankle Instability” genders.
FOOT For follow up assessment also X ray was utilised.

3 156 “One-Stage Closed Intramedullary Yan R et al patients aged 18 PELVIS Preoperatively, the fracture site for each patient was
Nailing for Delayed Femoral to 60 years with examined by X-ray.
Fracture in Multiple Injured delayed femoral HIP JOINT
Patients.” fracture were Postoperative follow up of the case.
studied FEMUR
4 157 “A Novel Suture-Preset Spring Plate Ruijian Yan, A total of 17 HUMERUS Comminuted coronoid fracture.Avulsion of the
System (SSPS) for Comminuted et al. patients (17 sides) medial collateral ligament (MCL) from the medial
Coronoid Process Fracture in the were included in RADIUS ULNA epicondyle. Patients were routinely followed-up in
Elbow” their study, the outpatient setting with clinical and radiographic
including 11 male ELBOW JOINT evaluation.
and six female,
with a mean age
range from 18 to
60 years.

5 160 “Safety and Functional Integrity of William Prior to any X-ray exposure, sensors were activated,
CGM Sensors When Used During Matievich et and a baseline reading was taken at least 30 minutes
Radiologic Procedures Under High al. from the time of sensor activation..
Exposure Conditions “
Functionality testing was performed immediately
following X-ray exposure to determine if any
malfunction occurred during the scanning period.
Data was collected for all devices immediately
following the final exposure. Device appearance
under X-ray imaging was also evaluated by exposing
the devices to a clinically relevant exposure setting.

6 160 “Safety and Functional Integrity of William SENSOR BASED Sensors were evaluated after each exposure session
CGM Sensors When Used During Matievich et SYSTEM (front and side orientations) for the first three
Radiologic Procedures Under High al ASSESMENT sessions, and then every 15 minutes of sequential
Exposure Conditions “ OF THE exposures until ten sessions (20 exposures) were
FUNCTIONALIT completed.
Y.
At the maximum exposure scan settings allowable by
each scanner, all devices passed the functionality
testing acceptance criteria in all exposure conditions
and orientations after each repeated exposure
session.

7 170 “Supine and erect abdominal Alzyoud K et ABDOMEN this study was to compare erect and supine
radiography: A comparison of al projections in terms of radiation dose and image
radiation dose and image quality.” ERECT & quality. Body mass index (BMI), sagittal body
SUPINE thickness, dose area product (DAP)and effective
POSTURE dose (ED) data were collected for 81 patients
referred for digital abdominal radiography in both
the supine and erect positions. The erect abdomen
radiograph increases the radiation dose and
decreases the image quality.
8 175 “ Comparison of Physical Therapy Mine Argali CERVICAL &

and Mulligan Mobilization Deniz et al. THORACIC
Technique in the Treatment of
Cervicogenic Headache” VERTEBRAE
SHOULDER

9 178 ” Evaluation of the clinical efficacy DEXIN ZOU et VERTEBRAL Pre- and post-operative bone mineral density,
of the bilateral pedicle cement al COLUMN injected cement volume, visual analogue scale (VAS)
anchoring technique in values, Oswestry disability index (ODI) scores, Cobb
percutaneous vertebroplasty for angle measurements and anterior vertebral height
Kümmell disease .“ (AVH) were recorded and assessed.
10 179 Lina et al, Pediatric age Several regions Reference levels of radiation dose used in the
group study hospital were found to be low compared to
“Reference Levels of Radiation European guidelines of 2018 reference levels. DRLs
Dose for Imaging in Pediatrics “ are described for each study and age group. They
concluded that at the hospital where the study was
conducted, reference levels of radiation in the
pediatric population are low.

10 180 ”Are Automated and Visual Grammatina 423 Moroccan FOREARM assessing bone age in children during puberty.
Greulich and PyleBased Methods Boitsios et al, Caucasian (MC)
Applicable to Caucasian European children,both girls WRIST
Children With a Moroccan Ethnic and boys were
Origin When Assessing Bone Age?” retrospectively HAND
, studied, aged
from 2 to 15 years
11 181 “HIGH-TECHNOLOGY MEDICAL ALBERTO The advantages of these devices are their simplicity,
EQUIPMENT MANAGEMENT: FUMAGALLI low cost, sufficient image resolution for diagnosis
IMPLEMENTATION OF A et al. purposes, good clinical efficacy, and flexibility to the
MULTIDISCIPLINARY DOSSIER FOR situations of use. Nevertheless, radiographic
HUMANITAS RESEARCH HOSPITAL” technique has numerous limitations and constraints.

12 191 “Chest Radiography: A Review of 5 Igoh et al ., The study Chest x-ray was normal in 68.9% of the subjects
Year Findings in Peripheral Facilities included 1039 while 783 (31.1%) patients showed various
in Jos, North -Central Nigeria. “ females and 1482 abnormal findings, like chest infection(20.1%) and
males. hypertensive heart disease (5.3%).Other findings
include heart failure (1.5%),
hypertension(1.5%),pleural effusion(1.0%) and
pulmonary tuberculosis (0.6%).
13 195 Assessment of interchangeable Junzhe Wu

applicability of two wear detection et al.
methods for total hip arthroplasty
within an experimental phantom-
model setup”

19 202 ” Association of serum creatinine Zhang, F et al, 9741 participants chest X-ray Their results indicated that the role of serum
with aortic arch calcification in examination creatinine levels in AAC and CVD development
middle-aged and elderly adults: an remains under recognised and undertreated in the
observational cross-sectional study general population
from China.”

6.5 Adverse event data
External vigilance database searches were carried out for Equivalent devices listed in chapter 4. The search time frame is 01.06.2013 to 01.06.2023.
Following databases were searched CDSCO and FDA MAUDE .
ID Search Strategy Database Total Events

AD1 Product Brand Name: BPL CDSCO 0
HRAD 32, BPL
AD2 Product Brand Name: Model CDSCO 0
- MX 32 HF Medion Health
care
AD3 Product Brand Name: CDSCO 0
MULTIX Impact Siemens
HealthCare
There were no adverse events found in CDSCO website. Therefore, further search is done in FDA MAUDE website for the listed devices to
identify reported adverse events related to the device. FDA MAUDE website contains adverse events of the products since last 10 years
and is considered as valuable source of information on Safety.
AD4 Product Brand Name: BPL FDA MAUDE 0
HRAD 32, BPL
AD5 Product Brand Name: Model FDA MAUDE 0
- MX 32 HF Medion Health
care
AD 6 Product Brand Name: FDA MAUDE 4
MULTIX Impact Siemens
HealthCare

Table 6 Adverse event data
Report Event Type Event Date Description Comments

Number
3003202425-2023- Malfunction 04/12/2023 Event Description This type of risk is
00001 It was reported to siemens healthineers that the already evaluated in risk
operator's hand was pinched between the tabletop and management. Following
middle module of the patient able. The event occurred are risk tags associated
during the positioning of a child patient on the multix with Pinching and cut to
impact patient table, the operator was positioning the human body parts (HZ-
child with one hand while his other hand was on the 06, and HZ-07).
tabletop for support. The operator's hand was pinched Moreover, Pinch points
between the tabletop and the middle module of the were appropriately
patient table due to the tabletop still floating after he labelled on the system
released the kick switch. The operator stated his thumb and also mentioned in
remained numb until the second day after the incident, the Manual [R1].
but he did not follow-up with medical treatment. It is
assumed that in a worst-case scenario, a moderate
injury could result if the event were to recur.
Manufacturer Narrative
E1: facility telephone number is (b)(6). A facility contact
name was not provided for reporting purposes. H10:

manufacturers preliminary analysis: the customer

service engineer found there is nearly no gap between
left side of the kick switch and the cover, so the kick
switch sometimes became stuck and it was not possible
switch back to its released position. The customer
service engineer made some adjustment for the room
between the kick switch and the cover. According to
service engineer's feedback the kick switch on the site
works fine after adjustment. The investigation is
ongoing. A supplemental report will be submitted if
addition information becomes available upon
completion of the investigation.
3003202425- Malfunction 10/04/2022 Siemens became aware on an incident with the multix This type of risk is
2022-4778 impact c unit. The user's finger was cut by a sharp edge already evaluated in risk
or corner when pulling out the tray of the bucky wall management. Following
stand (bws). No medical intervention was required. are risk tags associated
with Pinching (HZ-06,
and HZ-07). Moreover,
Pinch points were
According to the provided picture, the distance between appropriately labelled
the bws and the room wall was not sufficient, causing the on the system and also
user's hand to be cut on one of the metal pieces of the mentioned in the
bws while pulling out the tray. According to the current Manual
investigation, it is assumed that the bws was incorrectly
installed. A supplemental report will be submitted if

additional information becomes available. Internal id #

(b)(4).
3003202425- Injury 21/04/2022 According to the operator manual, it is responsibility of This type of stitching
2022-25425 the user to ensure that the patient hand grips are in examinations is not
correct position and do not stand in the way of the intended part of the HF-
detector moving up or down. In the reported event, the 400 system.
operator did not swing the handgrip to the side as
advised in the manual. Therefore, when the scoli exam
was started, the hand grip was not in proper position,
which led to the hand grip hitting the wall stand
workstation and dislocating. The stretch grip was
checked by siemens local service and found to be within
specifications. The multix impact c system works as
intended. Siemens is not aware of any similar incidents in
the field. Internal id # (b)(4).
Event Description
Siemens became aware of an incident that occurred on
the multix impact c device. When the x-ray technician
was preparing for a scoli series examination at the wall
stand, he neither removed the stretch grip nor checked
whether the overhead hand grip was firmly attached to
the wall stand. As the examination began, the stretch grip
caught the top of the multi purpose ortho stand causing
the handle to become loose and fall forward. The part fell

but missed the patient. There are no injuries attributed

to this event.
malfunction 24/07/2019 Manufacturer Narrative This type of risk is
3003202425- The concerned power cable is located under the table already captured in the
2019-91427 and enclosed in plastic cover. User is unable to touch the risk management file
cable. The table is grounded eliminating risk of potential under protection against
electrical shock to persons. A supplemental report will be Electrical risks. The
submitted if additional information becomes available. system is developed
(b)(6). according to IEC 60601
standards.
Event Description
Siemens became aware of an incident that occurred with
the multix imact unit. During table lift movement the
system suddenly stopped with a loud sound. No table
movements were possible following the incident.
Siemens local service engineer checked the unit and
found a power cable pinched under the table motor. The
insulation on the cable was broken. There are no injuries
attributed to this event. The reported event occurred in
(b)(6).
The investigation of the reported issue was completed
with the following result. The reported event was caused

by a motor power supply cable under the table that was

not properly installed. The cable was pinched between
the table motor (gear) and table lifting motor base during
the system movement. The concerned cable at the user
site was replaced by siemens local service. The system
was brought back to specifications and returned to use.
Siemens will be initiating a correction for the reported
issue via a field modification. The update instruction
xp041/19/s will be released to the field in the end of
september 2019.
Conclusion of literature search:
The Published clinical literature identifies the equivalent device usage often in Diagnostic Radiography examinations, However the device is not specifically
studied as part of the proving its performance per se. The application of the IEC 60601 provides verification of both performance and safety of the device
under evaluation.

7. Conclusion of Clinical Evaluation Report
The Clinical Evaluation Report of the HF-400 System summarises the clinical data from different sources relating to use of the Hf-400 system and its
equivalent devices. A combination of data extracted from pre-/non clinical data, the literature review as well as adverse event data has been selected
to demonstrate the safety and performance of the HF- 400 system.
A comprehensive literature search for the use of Hf-400 system and equivalent device was performed . Identified publications have been carefully
appraised, leading to an adequate number of relevant evidence based publications (n=20). Moreover, American college of radiology practice
parameters and appropriateness criteria were used. All aspects of the intended use, all indications of use listed in the User Manual [R1] have been
addressed. The literature search did not identify any risks, which have not yet addressed within the risk management.
The market experience of the equivalent devices provide valuable insights with regard to the clinical safety and performance. The detailed search of
the adverse events databases did not identify any risks which have not yet been assessed within the risk management. None of the identified reports
raises any concern regarding the safe and effective use of the HF- 400.
In addition, a quality management system manual is established for safe development and maintenance of Medical device manufactured by Saakshi.
The device has been verified and validated as per the following reports.
REV/Date: 00/01/02/2023
R8. BIS Certification Marks Licence No. CM/L- CM/L 3963176
3963176


26/05/2023 and Expiry Date:26/05/2026
The device HF- 400 is also provided with type approval from Atomic Energy Regulatory Board, Government of India.
In summary, the clinical evaluation confirms that:
 The HF 400 system complies with current knowledge, state fo the art technology.
 Consistency exists between state of the art, the evaluated data, the risk management documentation and information material supplied.
 Clinical benefits for the patients are achieved and the benefit from the use of the device outweighs possible adverse effects.
The clinical evaluation was conducted by suitable qualified individual.
8. References
No. Title of the Document Document ID
R1. Instructions for Use and service manual F/DOC/35
of HF 400 Rev/Date:-
00/18/01/2022
R2. Quality System Manual F/DOC/01, Date:
01.06.2017 Issue:
01
R3. Risk Management Plan F/MR/15,
Rev/Date:-
00/01/12/2021

R4. Risk Management and control F/MR/08A Rev :-

00Date:-20-12-21
R5. Risk Management Summary / Report F/MR/16 Date:
01/12/2021
N/A American College of Radiology. ACR–SPR N/A
Practice Parameter for General Radiography
Res. 30 – 2013, Amended 2014 (Res. 39)
Practice Parameter for the Performance of
Abdominal Radiography Res. 2 - 2016
N/A American College of Radiology. ACR–AAPM– N/A
SIIM Practice Parameter for Digital Radiography
Res. 40 – 2017, Amended 2014 (Res. 39)
N/A American College of Radiology. ACR–SAR N/A
Practice Parameter for the Performance of Adult
Cystography and Urethrography Res. 31 - 2015
N/A American College of Radiology. ACR–SAR N/A
Excretory Urography Res. 14 – 2014
N/A American College of Radiology. ACR Practice N/A
Parameter for the Performance of
Hysterosalpingography Res. 50 – 2011,
Amended 2014 (Res. 39)
Voiding Cystourethrography in Children Res. 13
– 2014
N/A American College of Radiology. ACR–ASSR– N/A
SPR–SSR Practice Parameter for the

Performance of Spine Radiography Res. 7 –

2017
N/A American College of Radiology. ACR–SIR N/A
Diagnostic Infusion Venography Revised 2018
(Resolution 15)
N/A American College of Radiology. ACR–SPR–SSR N/A
Practice Parameter for the Performance of Dual-
Energy X-Ray Absorptiometry (DXA) Res. 31 –
2013, Amended 2014 (Res. 39)
Radiography of the Extremities Res. 6 – 2018
Radiography for Scoliosis in Children Res. 15 –
2014
Practice Parameter for the Performance and
Interpretation of Skeletal Surveys in Children
Res. 10 - 2016
Practice Parameter for the Performance of Chest
Radiography Res. 56 – 2011, Amended 2014
(Res. 39)
Portable (Mobile Unit) Chest Radiography Res.
55 – 2011, Amended 2014 (Res. 39)

N/A American College of Radiology. ACR–ASNR– N/A

SPR Practice Parameter for the Performance of
Myelography and Cisternography Res. 9 – 2013,
Amended 2014 (Res. 39)
Practice Parameter for Imaging Pregnant or
Potentially Pregnant Adolescents and Women
with Ionizing Radiation - Revised 2018
(Resolution 39)
N/A American College of Radiology. ACR N/A
Appropriateness Criteria® (AC) – Diagnostic:
Cardiac, Gastrointestinal, Musculoskeletal,
Neurologic, Pediatric, Thoracic, Urologic,
Vascular, Womens
N/A https://www.imagewisely.org/imaging- N/A
modalities/computed-tomography/imaging-
physicians/articles/diagnostic-imaging-of-
thoracic-abdominal-pelvic-diseases. Diagnostic
Imaging of Thoracic-Abdominal-Pelvic Diseases
– The Role for MRI as a High
Diagnostic Yield, Safe and Cost-Effective
Alternative to CT, Image Wisely, Diego R.
Martin, MD, PhD University of Arizona, Tucson,
AZ (Updated Mar. 2017)
N/A https://www.imagewisely.org/Imaging- N/A
Modalities/Computed-Tomography/Imaging-
Physicians/Articles/Use-of-Ultrasound-as-an-
Alternative-to-CT. Use of Ultrasound as an
Alternative to CT, Image Wisely, Deborah

Levine, MD, FACR Beth Israel-Deaconess

Medical Center, Boston, MA (Updated Sept.
2016)
N/A American College of Radiology. Website URL: N/A
https://www.acr.org/
REV/Date: 00/01/02/2023
R8. BIS Certification Marks Licence No. CM/L- CM/L-3963176
3963176
26/05/2023 and Expiry Date:26/05/2026
9. About the Author

Dr. Bakki Sheshu Kumar, MBBS MD
This Clinical evaluation report is performed by Dr. Bakki Sheshu Kumar, MBBS MD from Company CERFINITY in accordance with Inputs provided by Saakshi
Medtech and Panels Limited. For the purpose of CER literature study, the publicly available literature of equivalent device is obtained and evaluated for CER.
Dr. Bakki Sheshu Kumar, MBBS, MD has overall 13 years of experience which includes Assistant professor in various Government and Private Medical
colleges, clinical practice and Clinical Lab Management. He has been author and review of multiple medical publications and had provided research
guidance to the medical graduates as Assistant Nodal officer of Multi Disciplinary Research unit and Member in postgraduates dissertations approval
committees.

The present clinical evaluation report has been written in close cooperation with responsible personnel from Saakshi Medtech and Panels Ltd.
10. Revision History

Revision Author Details
00 Dr. Bakki Sheshu Kumar Initial Version
Appendix: Detailed Indications for radiography according to ACR Appropriateness Criteria
Area of “Usually appropriate” “May be appropriate” “Usually not Contraindications

application appropriate”
Gastrointestinal Blunt abdominal injury (both Acute non-localized acute, diffuse stomach Absolute contraindications are
stable and unstable patient) stomach discomfort that discomfort. Patient with not present. Prior to doing
is either feverish or not. neutropenia. primary radiography, like with any
imaging. operations, the relative
No recent surgery/other advantages and hazards of the
information provided. first procedure should be assessed.
imaging. Because the uterus is usually
Dysphagia (depending on the X-ray procedures. For detailed Imaging of suspected always within the main beam
information, refer to ACR Appropriateness Criteria® for chronic mesenteric for exams using abdominal
dysphagia) ischemia radiography, pregnancy is a


Suspected intermittent or low- Crohn disease Right lower quadrant relative contraindication to
grade suspected small-bowel pain – suspected these procedures. Radiation
obstruction Imaging of suspected appendicitis exposure hazards should be
acute mesenteric reduced for patients by taking
ischemia the proper safeguards.
Left-lower quadrant pain
– suspected diverticulitis
Palpable abdominal
mass
Suspected high-grade
small-bowel obstruction
Cardiac Acute chest pain (suspected Asymptomatic patient at Suspected There are no absolute
aortic dissection) risk for coronary artery arrhythmogenic contraindications. As with all
disease cardiomyopathy procedures, the relative
benefits and risks of the
Acute non-specific chest pain – Acute non-specific chest Asymptomatic patient at procedure should be evaluated
low probability of coronary artery pain – low probability of risk for coronary artery prior to the performance of
disease: X-ray chest coronary artery disease: disease radiography. Appropriate
X-ray rib views, X-ray precautions should be taken to
barium swallow and minimize patient risks,
upper GI series, X-ray including radiation exposure
thoracic spine


Blunt chest trauma Chest pain suggestive of Suspected hypertrophic especially for pregnant or
acute coronary syndrome cardiomyopathy potentially pregnant women.
Chronic chest pain – high Differentiating new-

probability of coronary artery onset heart failure with
disease reduced ejection
fraction from new-onset
heart failure with
preserved ejection
fraction
Dyspnea-suspected cardiac Confirmed new-onset

origin heart failure with
reduced ejection
Known or suspected congenital fraction of uncertain
heart disease in the adult etiology: ischemic
Suspected myocardial infiltrative versus nonischemic
disease
Suspected acute/subacute
myocardial disease
Suspected new-onset nonacute

heart failure, not previously
diagnosed


Suspected infective endocarditis
Suspected pulmonary embolism
Musculoskeletal Acute trauma of hand and wrist, Suspected spine trauma: Acute knee trauma There are no absolute
ankle, foot, knee Initial imaging for blunt without focal contraindications. As with all
trauma tenderness, no effusion, procedures, the relative
able to walk benefits and risks of the
procedure should be evaluated
Acute hip pain - suspected Next study for chronic Acute foot trauma, does prior to the performance of
fracture ankle pain – ankle not meet the Ottawa radiography. Appropriate
radiographs Rules, no focal precautions should be taken to
normal/nonspecific, tenderness or palpable minimize patient risks,
suspected ankle abnormality, able to including radiation exposure
instability walk, neurologically especially for pregnant or
intact potentially pregnant women.
Acute injury to the ankle Acute injury to the
with >1 week persistent ankle, does not meet
pain. Initial radiographs the Ottawa Ankle rules.
negative No point tenderness
over the malleoli, talus,
or calcaneus on
physical examination.
Able to walk.
Neurologically intact


Initial imaging for chronic pain of Acute injury to the ankle. Next study for chronic
the ankle, elbow, foot, hip, knee, Radiographs ankle pain – except for
wrist, back (suspected demonstrate talus suspected ankle
sacroiliitis/spondyloarthropathy), fracture instability
extremity joint pain (suspected
inflammatory arthritis)
Follow-up of osseous tumor, with Suspected collateral Computer navigation of

and without significant hardware ligament tear; hip arthroplasty or
present radiographs modeling
nondiagnostic
Initial imaging after arthroplasty Ankle radiographs that Chronic knee pain,
of shoulder, hip, knee are normal or nonspecific initial knee radiograph
and suggest ankle demonstrates:
instability are the results osteochondritis
of the next test for dissecans, loose
persistent ankle bodies, or history of
discomfort. meniscal
repair/degenerative
changes or
chondrocalcinosis/signs
of prior osseous injury
(next imaging
procedure)


Osteonecrosis of the hip Evaluating patients with a Next study for chronic
painful primary metal-on- wrist pain - except for
metal total hip the case of suspected
arthroplasty or surface occult fracture or stress
replacement fracture
Osteoporosis (for suspected Total hip arthroplasty, Evaluation for

fracture) suspected nerve damage metastatic disease to
the lung from
musculoskeletal
primary
Primary bone tumors Soft-tissue tumors

(screening)
Initial imaging for shoulder pain Lesions on radiographs (Primary bone tumors), for
(atraumatic and traumatic) further details on each variant, refer to ACR
Appropriateness Criteria® for Primary Bone Tumors.
Initial imaging for soft-tissue Suspected acute cervical Cervical spine imaging
mass spine trauma, imaging not indicated by NEXUS
indicated by NEXUS or or CCR clinical criteria
Stress fracture, including CCR clinical criteria
sacrum, excluding other
vertrebae


Suspected osteomyelitis of the

foot in patients with diabetes
mellitus
Suspected osteomyelitis, septic

arthritis, or soft tissue infection
(excluding spine and diabetic
foot)
Suspected cervical spine trauma
Follow-up imaging on patient

with no unstable injury
demonstrated initially, but kept in
collar for neck pain
Suspected spine trauma:

Pediatric patients <14 years,
with known cervical, thoracic,
lumbar fracture
Suspected spine trauma:

Pediatric patients <14 years,
alert no neck or back pain, neck
supple, fractured femur


Neurologic First study for chronic neck pain X-ray myelography and Next study for chronic There are no absolute
post myelography CT neck pain after contraindications. As with all
spine for positional radiographs procedures, the relative
headache benefits and risks of the
procedure should be evaluated
Imaging in the diagnosis of Acute, subacute, or Acute, subacute, or prior to the performance of
thoracic outlet syndrome chronic low back pain or chronic low back pain or radiography. Appropriate
radiculopathy. One or radiculopathy. No red precautions should be taken to
more of the following: flags, no prior minimize patient risks,
suspicion of cancer, management including radiation exposure
infection, or especially for pregnant or
immunosuppression potentially pregnant women.
Acute, subacute, or chronic Acute, subacute, or Low back pain with
uncomplicated low back pain or chronic low back pain or suspected cauda
radiculopathy. One or more of radiculopathy. Surgery or equine syndrome or
the following: low velocity intervention candidate rapidly progressive
trauma, osteoporosis, elderly with persistent or neurologic deficit
individual, or chronic steroid use progressive symptoms
during or following 6
weeks of conservative
management
Penetrating neck injury - clinical Low back pain or

soft injury signs radiculopathy. New or
progressing symptoms or


clinical findings with Cervical spine imaging

history of prior lumbar not indicated by NEXUS
surgery or CCR clinical criteria
Suspected cervical spine trauma Traumatic/painful/sudden

– Follow-up imaging on patient onset or slowly
with no unstable injury progressive myelopathy
demonstrated initially, but kept in
collar for neck pain. Returns for
evaluation
Suspected spine trauma in Suspected acute cervical

pediatric patients <14 years, spine trauma. Imaging
with known cervical fracture/with indicated by clinical
known thoracic or lumbar criteria (NEXUS or CCR)
fracture - Not otherwise specified,
myelopathy, treatment
planning for mechanically
unstable spine, patient
persistently clinically
unevaluable for >48
hours, clinical or imaging
findings suggest
ligamentous injury,
neurologic abnormalities


Suspected spine trauma

in pediatric patients <14
years, alert, no neck or
back pain, neck supple,
fractured femur
Thoracic Acute respiratory disease in Using a portable X-ray There are no absolute
individuals with machine for intensive contraindications. As with all
immunocompetent status, with care unit (ICU) patients to procedures, the relative
the exception of remove their chest tubes benefits and risks of the
immunocompetent patients procedure should be evaluated
experiencing a simple acute prior to the performance of
asthma attack. radiography. Appropriate
precautions should be taken to
acute respiratory ailment Exacerbation of minimize patient risks,
(asthma, COPD) in uncomplicated acute including radiation exposure
immunocompromised people. asthma in especially for pregnant or
immunocompetent potentially pregnant women.
individuals.
Blunt chest trauma Bronchogenic carcinoma

clinical staging without
Chronic dyspnea – non invasive procedures
cardiovascular origin


Hemotypsis
Imaging in the diagnosis of

thoracic outlet syndrome
Imaging of possible tubercolosis
Patients in the intensive care

unit (ICU) can use a portable X-
ray machine if they are being
admitted or transferred, have
clinical deterioration, or have
just had a tube or catheter
inserted.
Occupational lung diseases

(exposure of silica, coal dust,
asbestos)
Rib fractures
pulmonary embolism or
pulmonary hypertension
suspected
Urologic Post-treatment follow-up of renal Hematuria, with the Acute onset flank pain – There are no absolute
cell carcinoma exception of: those who pregnant patients contraindications. The
engage in strenuous procedure's minimal hazards


physical activity, people must be outweighed by any

who have an infection or potential advantages.
a viral sickness, people
who are currently Prior major reactions to
menstruating, and iodinated contrast media,
individuals who have known or suspected latex
renal parenchymal allergies, acute urinary tract
disease as the underlying infections, recent urethral or
cause of hematuria. bladder surgery, possible
urethral trauma, and high
invasive transitional cell Post-treatment Acute pyelonephritis spinal damage (risk of
carcinoma after bladder cancer surveillance of bladder autonomic dysreflexia) are all
treatment: cystectomy or no cancer: Superficial warning signs that caution
cystectomy transitional cell should be used.
carcinoma; no invasion;
with risk factors To reduce patient hazards,
including radiation exposure,
Pre-treatment staging of Microscopic hematuria Patients with hematuria appropriate measures should
muscle-invasive bladder cancer and blunt abdominal include those who have be implemented, especially for
trauma without any other just menstruated, paediatric patients and
suspected abdominal exercised vigorously, pregnant or potentially
injuries had an infection or viral pregnant women.
sickness, or have renal
parenchyma disease.


Acute onset flank pain - Incidentally discovered

Recurrent symptoms of adrenal mass
stone disease
Renal carcinoma staging Penetrating truma or Indeterminate renal

abdominal injury; mass
suspicion of multisystem
Blunt abdominal injury or trauma, with or without Lower urinary tract
trauma; suspicion of hematuria symptoms – suspicion
multisystem trauma, with of benign prostatic
hematuria hyperplasia
Staging of testicular malignancy Post-treatment follow-

(chest radiography) up of prostate cancer
Suspected lower urinary tract Recurrent urinary tract

trauma infection in women
Renal failure
Vascular Blunt abdominal trauma Abdominal and pelvic Planning for pre- Absolute contraindications are
radiography for follow-up endovascular repair not present. Prior to doing
after open abdominal open repair of the radiography, like with any
aortic aneurysm abdominal aortic operations, the relative
endovascular repair aneurysm using


Blunt chest trauma – suspected Imaging of mesenteric radiography of the advantages and hazards of the
aortic injury ischemia (suspected abdomen and pelvis procedure should be assessed.
acute mesenteric
ischemia) Relative contraindications
include, but are not limited to:
Chylothorax treatment planning Suspected thoracic aortic
aneurysm 1. Cellulitis or other local
infections that need venous
Clinically suspected pulmonary Follow-up for post- access are relative
arteriovenous malformation thoracic endovascular contraindications, although
repair of thoracic aortic they are not the only ones.
disease
2. Serious iodinated contrast
Imaging in the diagnosis of media sensitivity.
thoracic outlet syndrome
3. Renal insufficiency,
Nontraumatic aortic disease particularly in individuals with
diabetes or congestive heart
Penetrating neck injury
failure, who are not receiving
Upper extremity swelling dialysis.
Gynecology Defecatory dysfunction Infertility Postmenopausal As with all procedures, the

(Hysterosalpingography) subacute or chronic relative benefits and risks of the
pelvic pain procedure should be evaluated


chest x-ray for newly discovered Anal incontinence Pretreatment planning prior to the performance of
endometrial cancer; when of invasive cancer of the radiography.
imaging is required for therapy cervix (chest
preparation radiography) for: FIGO Hysterosalpingography should
stage >Ib not be performed on a woman
who is pregnant or who could
Except for anal incontinence, Pretreatment planning of Clinically suspected be pregnant.
pelvic floor dysfunction is a invasive cancer of the postoperative
clinically suspected cervix (chest complication following
postoperative consequence radiography) for: FIGO pelvic floor repair Further Hysterosalpingography
after pelvic floor reconstruction. stage Ib1, tumor size <4 should not be performed when
cm; FIGO stage Ib2, ongoing pelvic infection or
tumor size >4cm active vaginal bleeding is
present.
X-ray chest for post-
therapy evaluation in
patients with clinically
suspected recurrence An allergic history or an
unexpected reaction to
iodinated contrast media are
relative contraindications that
may necessitate premedication
with diphenhydramine,
steroids, and/or other
medications.


Appendix 2: Literature Search Report of HF 400
Literature Search Report for HF-400
1. Introduction and Background
1.1 Purpose and objective:
This report documents the protocol, appraisal and results of literature search to identify the clinical data that is not held by the manufacturer but
may assist in clinical evaluation of safety and performance of HF-400 System. This document provides the record of literature search performed,
evaluation of methods used, verification of the results and parameters for the search to be reproduced.
1.2 Scope
The scope of this document applies to the creation of a systematic literature search report for HF-400 system.
2. Literature Search Protocol

2.1 Literature search research question
The current state in the assessment and analysis of the clinical data on the safety and performance of the clinical use of radiography products.
2.2 Literature databases/Sources

The following databases/sources were used for the literature search
PubMed: PubMed comprises over 22 million citations for biomedical literature from MEDLINE, life science Journals and online books. Compiled by
the United states National library of Medicine (NLM), Medline is available on the internet and searchable via PubMed. Along with Cochrane library
and number of other databases, Medline facilitates evidence based medicine. Most sutematic review articales published nowadaus buld on
extensive searches of PubMed.
Google Scholar: Google Scholar is a freely accessible web search engine that indexes the full text or metadata of scholarly literature across an array
of publishing formats and disciplines.
Google Scholar allows users to search for digital or physical copies of articles, whether online or in librariesIt indexes "full-text journal articles,
technical reports, preprints, theses, books, and other documents, including selected Web pages that are deemed to be 'scholarly.
2.3 Equivalent, Predicate or similar devices
The following devices will be included in the literature search:

 BPL HRAD 32, BPL
 Model - MX 32 HF Medion Health care
 MULTIX Impact Siemens HealthCare
2.4 Search Terms and Queries
The following search terms and queries were used during the literature search. The searches were conducted over the period from 01.01.2021 to
01.06.2023. This period will provide the recent advances and practices of the radiography in clinical use.
Table: Search Terms

ID# Search Term Categories Justification Search Terms Hits
PUBMED
ST#1P X-ray Radiography X-ray Radiography is the intended use. 149

( X-ray radiography) AND (((Siemens)
OR (phillips) OR (Medion) OR (CANON)
OR (BPL) OR (BPL) OR (CArestream) OR
(GE Healthcare)))
Filters applied: Free full text, Full text,

Clinical Trial, Randomized Controlled
Trial, Humans, from 2021 - 2023/6/30.
ST#2P Siemens Multix Impact Equivalent Device Siemens Multix Impact 2
ST#3P BPL HRAD 32 Equivalent Device BPL HRAD 32 0
ST#4P Model - MX 32 HF Medion Health care Equivalent Device Model - MX 32 HF Medion Health care 0
Google Scholar
ST#1G Siemens Multix Impact Equivalent Device Siemens Multix Impact 62

Since 2021

ST#2G Equivalent Device BPL "HRAD" 4

BPL HRAD 32
ST#3G Model - MX 32 HF Medion Health care Equivalent Device Medion healthcare Model MX 6
Total 223
2.5 Duplication of data
To prevent duplication in analysis the duplicate articles listed in multiple databases were identified by sorting titles, list of authors.
2.6 Exclusion Criteria
EC ID Exclusion Criteria
EC-1 Publications in languages other than English
EC-2 EC-2 Publications not related to X-ray Radiography,( Related to CT, MRI, US, RSA or other modality)
EC-3 Publications with low medical level of evidence (Clinical, Expert opinion, review articles , letter to
editor)

EC-4 Publications with Phantom, animal/cadaveric studies and not human studies
EC-5 Publications without full text availability
2.7 Appraisal Criteria
The selected clinical data was filtered using the following appraisal criteria. Clinical data scoring less than 8 are excluded from the analysis stage.
Relevance Criteria SCORE
3 2 1
Appropriate Device S1- Actual Device S2- Comparable Device S3- Other Device
Was the device used for the same I1-Same Use I2- Minor Deviation I3- Major Deviation
intended use?
Appropriate patient group P1- Same Patient Group P2- Similar P3-Different
population
Acceptable report/data collection D1- Sufficient D2- Minor deficiencies D3- Insufficient
Information
(Evidence from well designed randomized (Suggestive evidence (From non-randomised
controlled trials) studies) Evidences (Expert judgement,)

Further appraisal was based on methodological quality and scientific validity of the data. The grading provided during this appraisal was considering
during data analysis.
Appraisal Criteria for data contribution
Quality measures Applicable criteria Scale

Study Design: Adequacy of sample size SD-3 SD-2 Sd-1
Was the study design Non-Biased study Fair study design
appropriate? Adequacy of applied controls Good study Design Poor Study Design
Adequacy of inclusion and
exclusion criteria and of
stratification of patients
Outcome measures: Did the study describe efficient Yes No

Do the outcome measures out comes
reported reflect the intended
performance of the device?
Adverse effects (AEs) Were the adverse effects Yes No
considered and/or reported in
the outcome of the study?

Clinical Significance Did the article observe clinical CS-3 CS-2 CS-1
significant effect ?
Clinical Effect was Clinical effect was Clinical effect was not observed
observed and proven to partially observed or clinical effect was observed
be clinically significant. with Fair statistics but is unacceptable
Suitable articles, including their relevance and quality grading are listed and are intended as input for the analysis of the clinical evaluation.
2.8 Data Integrity

Data integrity is ensured by defining and documenting the search strings and exclusion citeria. Furthermore, an unbiased review and appraisal was
performed, including positive and negative data about the device. These steps were documented and shown in literature search workbook.

3. Literature search results

3.1 Search date: 15-06-2023
3.2 Search Results overview
Stage1: Search of databases (Pubmed and Google scholar)
Found: 223
Stage 2:
Selection: Exclusion criteria and relevance criteria
Suitable: 13
Stage 3: Quality appraisal and analysis is documented

2 .3 Suitable scientific literature:
152:
A published study by Zeng GL et, al. Titled “Anterior Talofibular Ligament All-Inside Arthroscopic Reconstruction with InternalBrace™ for Chronic Lateral Ankle
Instability” has used SIEMENS MULTIX Impact for radiographic evaluation in their study of retrospective evaluation of feasibility and safety of InternalBrace™
reconstruction treatment of anterior talofibular ligament under total arthroscopy for CLAI patients, and analyzed its clinical effects , clinical data of 108 patients
randomly selected in the Dongguan Hospital of Traditional Chinese Medicine, over a period of 2 years. Inclusion criteria were: age 19–58 years, repeated
painful ankle sprains and failure to respond to conservative treatment for 6 months, unstable walking, and limited sensorimotor function. All-inside ATFL
reconstruction with an InternalBrace™ under arthroscopy has significant superiority in ankle stability after surgery which allows early rehabilitation, and can
restore the ankle function and satisfy the need for sports function in Chronic Lateral Ankle Instability.
156:
Yan R et al , in their study titled “ One-Stage Closed Intramedullary Nailing for Delayed Femoral Fracture in Multiple Injured Patients.”, which was a
retrospective study conducted on delayed femoral shaft fracture , where multiple injured patients aged from 18 to 60 years with delayed femoral fracture and
treated by one-stage internal fixation technique, were included. They have used Siemens, MULTIX Impact, for pre operative evaluation of the fracture site.
This study aimed to investigate: (i) whether the closed reduction can be acquired by the unilateral extendable external fixator in delayed femoral fracture; (ii)
whether the one-stage closed intramedullary nailing can be carried out effectively for patients; (iii) the clinical effects and functional recovery of this technique.
Their results showed that: (i) the unilateral extendable external fixator could provide sufficient mechanical distraction strength for the shortened delayed
femoral fractures; (ii) the fixator-assisted nailing technique could achieve good closed reduction for most cases; (iii) the one-stage protocol could promote the
fracture union and have low complication rate with satisfactory functional recovery. They conclude that one-stage fixator-assisted nailing provides a minimally
invasive strategy for most of the patients safely and restores the extremity length, thus it is a useful and effective technique.

157:
A study by Ruijian Yan, et al, “A Novel Suture-Preset Spring Plate System (SSPS) for Comminuted Coronoid Process Fracture in the Elbow”, which was a
retrospective study carried out in the patients with comminuted fractures of the coronoid treated by this novel method , SPSS fixation .A total of 17 patients
(17 sides) were included in their study, including 11 male and six female, with a mean age range from 18 to 60 years. They have utilised x-ray Siemens, MULTIX
Impact radiography instrument in their study for pre operative elbow fracture assessment. Their results gave supportive evidence for this novel method ,
during the immediate post operative and follow up periods. Hence , they concluded that the SSPS method can provide a reliable fixation for the comminuted
coronoid fracture with satisfactory clinical outcome.
160:
A study titled “Safety and Functional Integrity of CGM Sensors When Used During Radiologic Procedures Under High Exposure Conditions “ by William
Matievich et al. Sensors were loaded with simulated glucose data and exposed to X-ray scanning, computed tomography (CT), and magnetic resonance
imaging (MRI) to simulate radiotherapeutic procedures. A Siemens Multix QDR SERIES X-ray scanner (Siemens, Munich) was used for X-ray exposure
evaluations. They found that all sensors passed all acceptance criteria following each session of X-ray, CT, and MRI exposures. Hence , they could conclude
that the sensors maintained functionality following a series of high exposure conditions in both X-ray and CT scanning systems, and the sensors were easily
visible and identifiable when scanned using clinically relevant scanning parameters.
170:
Alzyoud K et al did a study by name “Supine and erect abdominal radiography: A comparison of radiation dose and image quality.” The aim of this study was
to compare erect and supine projections in terms of radiation dose and image quality. Body mass index (BMI), sagittal body thickness, dose area product
(DAP)and effective dose (ED) data were collected for 81 patients referred for digital abdominal radiography in both the supine and erect positions. Image
quality was assessed by both visual and quantitative methods. The estimated ED in the erect position was 102% higher compared to the supine position. The
mean ± SD visual image quality was reduced (27%) when using an erect position 1.9 ± 0.5 when compared with supine 2.6 ± 0.7. The calculated signal to noise
ratio (SNR) was higher in erect position by 14%. Contrast to noise ratio (CNR) was reduced by 16% when using an erect position. A single projection is likely to
be sufficient but in certain situations, for example in case of absence of a computed tomography (CT) scanner or ultrasound, then an additional erect abdominal

radiograph may be warranted. The erect abdomen radiograph increases the radiation dose and decreases the image quality. Their study findings support the
continued use of the supine position as the preferred method due to significant reductions in radiation dose when compared to erect imaging.
175:
“ Comparison of Physical Therapy and Mulligan Mobilization Technique in the Treatment of Cervicogenic Headache” a study by Mine Argali Deniz et al. The
aim of this investigate the effectiveness of the conventional physical therapy and Mulligan mobilization technique in the treatment of Cervicogenic Headache
(CH) and to compare the effectiveness of these two methods. A total of 40 patients with CH were studied. For neck lordosis angle, lateral radiographs were
taken with Siemens Multix digital radiography device (Siemens AG Healthcare Sector, Erlangen, German) was used in this study.
Neck Disability Index and Beck Depression Scale decreased and restriction of movements, ROM, cervical performance and lordosis angle increased
significantly in both groups. They found that both treatments were found to have positive effects on radiological and clinical findings of CH, but Mulligan
mobilization technique was found to be more effective in all evaluations except neck extension and right lateral flexion ROM measurements.
178:
DEXIN ZOU et al, in a study with title” Evaluation of the clinical efficacy of the bilateral pedicle cement anchoring technique in percutaneous vertebroplasty
for Kümmell disease .“ Their study aimed to evaluate the clinical efficacy of the bilateral pedicle cement anchoring technique combined with the postural
reduction in percutaneous vertebroplasty (PVP) for Kümmell disease. Pre- and post-operative bone mineral density, injected cement volume, visual
analogue scale (VAS) values, Oswestry disability index (ODI) scores, Cobb angle measurements and anterior vertebral height (AVH) were recorded and
assessed. Siemens Multix Fusion radiograph instrument was used to evaluate these parameters. The results showed , the treatment of Kümmell disease
with PVP, the bilateral pedicle cement anchoring technique combined with postural reduction can achieve good clinical outcomes and the changes in the
Cobb angle and AVH before and after surgery were also statistically significant in the radiological evaluation.
179:
“Reference Levels of Radiation Dose for Imaging in Pediatrics “, a study by Lina et al, carried out to show the Dose Reference Levels (DRLs) used in the
institution to which the authors belong, in the CT, radiography and fluoroscopy modalities and to compare them with international standards. This was a

retrospective descriptive cross-sectional study. Multix MP from Siemens, equipped with a DAP (dose area product) dose meter was used for this study.
Reference levels of radiation dose used in the hospital were found to be low compared to European guidelines of 2018 reference levels. DRLs are described
for each study and age group. They concluded that at the hospital where the study was conducted, reference levels of radiation in the pediatric population
are low.
180:
”Are Automated and Visual Greulich and PyleBased Methods Applicable to Caucasian European Children With a Moroccan Ethnic Origin When Assessing
Bone Age?” , a study carried out by Grammatina Boitsios et al, to test the accuracy of the visual and automated bone age assessment base on the Greulich
and Pyle (GP) method in healthy Caucasian European children with a Moroccan ethnic origin. 423 Moroccan Caucasian (MC) children were retrospectively
studied, aged from 2 to 15 years with a normal left-hand radiograph performed to rule out a trauma. Dorso-palmar radiographs of left hand to rule out a
musculoskeletal trauma are acquired on a Siemens Multix TOP radiography. Visual bone age assessment was related to the CA in both girls and boys .
Automated bone age assessment was related to the CA in both girls . They concluded that Visual and automatic bone age assessment based on the GP
method, previously validated in the general population of Caucasian European children, can be confidently used in healthy Caucasian European children
with a Moroccan ethnic origin. Attention should be drawn assessing bone age in children during puberty where a more significant variability in bone age
determination is observed with both methods, particularly in Moroccan boys.
181
“HIGH-TECHNOLOGY MEDICAL EQUIPMENT MANAGEMENT: IMPLEMENTATION OF A MULTIDISCIPLINARY DOSSIER FOR HUMANITAS RESEARCH HOSPITAL” a
thesis submitted by ALBERTO FUMAGALLI et al. They have studied on , Siemens Multix Fusion Digital Radiography system, present in Humanitas hospital. At
the top the x-ray tube structure, while at the bottom and on the right the Flat Panel Detectors. The use of one or the other depends on the body district to
be imaged. The patient may be imaged from several angles. An x-ray session usually lasts about 10 minutes. Then, images could be either developed from an
x-ray film or written to a CD, depending on the used technique. Such as in the other x-ray-based devices, a contrast medium may be injected to the patient.
The advantages of these devices are their simplicity, low cost, sufficient image resolution for diagnosis purposes, good clinical efficacy, and flexibility to the
situations of use. Nevertheless, radiographic technique has numerous limitations and constraints. Just to list a few examples: the fact that it provides a two-

dimensional projection of a three-dimensional structure, thus losing depth information (limit overcome by CT technologies); the fact that the geometry of
the system could cause a low precision in the output, for example due to the presence of an enlargement factor.
Training courses for internal technicians: this is one of the most important goal of this work. Installed software (“software installati”): pc installed software.
In this case it is necessary to distinguish the company's own software or traditional software; for instance, considering the Siemens RMNs, all the system are
based on Syngo, which is a Siemens software; while, considering Philips RMNs, they are based on a generic Windows version.
191
Igoh et al ., in their study, “Chest Radiography: A Review of 5 Year Findings in Peripheral Facilities in Jos, North -Central Nigeria. “ , with an objective to
review the chest radiographic findings in peripheral facilities in Jos North Central Nigeria over a period of five years. A five (5) year retrospective review of
the archive of chest radiographs referred from peripheral facilities. The study included 1039 females and 1482 males. The chest x-ray examination was
performed using a multix swing floor mount 500MAs X ray machine(Siemens, 2007 Germany) fitted with a chest stand and a stationary grid. Chest x-ray was
normal in 68.9% of the subjects while 783 (31.1%) patients showed various abnormal findings, like chest infection(20.1%) and hypertensive heart disease
(5.3%).Other findings include heart failure (1.5%), hypertension(1.5%),pleural effusion(1.0%) and pulmonary tuberculosis (0.6%).The least findings were lung
metastasis and rib fracture following road traffic accidents constituting 0.1% each. Their study have concluded that ,multiple aetiologies are responsible for
the request for chest Radiographic evaluation Chest radiography is an effective, cheap and complementary imaging tool in evaluating cardiovascular,
respiratory and musculoskeletal systems.
202
Zhang, F et al, have published an article titled” Association of serum creatinine with aortic arch calcification in middle-aged and elderly adults: an
observational cross-sectional study from China.” have studied on 9741 participants were recruited from health examination program of Qinglong
Community of Changzhou city, Jiangsu Province, China. Aortic arch calcifcation (AAC) was assessed using postero-anterior chest X-ray examination (Multix
Select DR, Siemens, Germany). AAC evaluation was executed on the basis of the image in chest X-ray examination on an electronic medical record by trained
radiologists blinded to each participant’s information. They investigated the association of serum creatinine levels with prevalence of aortic arch calcifcation
(AAC) in a larger middle-aged and elderly Chinese population. Our data suggested serum creatinine levels are signifcantly associated with AAC in female

aged>45 years old. Their results indicated that the role of serum creatinine levels in AAC and CVD development remains under recognised and undertreated
in the general population. Thus, they concluded that AAC or asymptomatic CVD risk screening should be given for female with increased serum creatinine
levels, especially in individuals concomitant with other CVD risk factors.
LITERATURE REVIEW SUMMARY TABLE
STUD TITLE OF STUDY AUTHOR PATIENT DETAILS TYPE OF REMARKS

Y RADIOGRAPHY
NUM
S.NO BER
1. 152 “Anterior Talofibular Zeng GL 108 patients of age LEG, Assessment of arthroscopic reconstruction to visualise the
Ligament All-Inside et, al. 19-58 years brace & joint contour improvement after the surgery.
Arthroscopic included both ANKLE JOINT &
Reconstruction with genders. For follow up assessment also X ray was utilised.
Internal Brace™ for FOOT
Chronic Lateral Ankle
Instability”

2. 156 “One-Stage Closed Yan R et patients aged 18 to PELVIS Preoperatively, the fracture site for each patient was
Intramedullary Nailing for al 60 years with examined by X-ray.
Delayed Femoral Fracture delayed femoral HIP JOINT
in Multiple Injured fracture were Postoperative follow up of the case.
Patients.” studied FEMUR
3. 157 “A Novel Suture-Preset Ruijian A total of 17 HUMERUS Comminuted coronoid fracture.Avulsion of the medial
Spring Plate System Yan, et al. patients (17 sides) collateral ligament (MCL) from the medial epicondyle.
(SSPS) for Comminuted were included in RADIUS ULNA Patients were routinely followed-up in the outpatient
Coronoid Process their study, setting with clinical and radiographic evaluation.
Fracture in the Elbow” including 11 male ELBOW JOINT
and six female, with
a mean age range
from 18 to 60 years.

4. 160 “Safety and Functional William Prior to any X-ray exposure, sensors were activated, and a
Integrity of CGM Sensors Matievich baseline reading was taken at least 30 minutes from the
When Used During et al. time of sensor activation..
Radiologic Procedures
Under High Exposure Functionality testing was performed immediately following
Conditions “ X-ray exposure to determine if any malfunction occurred
during the scanning period. Data was collected for all
devices immediately following the final exposure. Device
appearance under X-ray imaging was also evaluated by
exposing the devices to a clinically relevant exposure
setting.

5. 160 “Safety and Functional William SENSOR BASED Sensors were evaluated after each exposure session (front
Integrity of CGM Sensors Matievich SYSTEM and side orientations) for the first three sessions, and then
When Used During et al ASSESMENT OF every 15 minutes of sequential exposures until ten sessions
Radiologic Procedures (20 exposures) were completed.
Under High Exposure THE
Conditions “ FUNCTIONALITY . At the maximum exposure scan settings allowable by each
scanner, all devices passed the functionality testing
acceptance criteria in all exposure conditions and
orientations after each repeated exposure session.

6. 170 “Supine and erect Alzyoud K ABDOMEN this study was to compare erect and supine projections in
abdominal radiography: A et al terms of radiation dose and image quality. Body mass index
comparison of radiation ERECT & SUPINE (BMI), sagittal body thickness, dose area product (DAP)and
dose and image quality.” POSTURE effective dose (ED) data were collected for 81 patients
referred for digital abdominal radiography in both the
supine and erect positions. The erect abdomen radiograph
increases the radiation dose and decreases the image
quality.
7. 175 “ Comparison of Physical Mine CERVICAL &

Therapy and Mulligan Argali THORACIC
Mobilization Technique in Deniz et
the Treatment of al. VERTEBRAE
Cervicogenic Headache”
SHOULDER

8. 178 ” Evaluation of the clinical DEXIN VERTEBRAL Pre- and post-operative bone mineral density, injected
efficacy of the bilateral ZOU et al COLUMN cement volume, visual analogue scale (VAS) values,
pedicle cement anchoring Oswestry disability index (ODI) scores, Cobb angle
technique in measurements and anterior vertebral height (AVH) were
percutaneous recorded and assessed.
vertebroplasty for
Kümmell disease .“
9. 179 Lina et al, Pediatric age group Several regions Reference levels of radiation dose used in the hospital were
study found to be low compared to European guidelines of 2018
“Reference Levels of reference levels. DRLs are described for each study and age
Radiation Dose for group. They concluded that at the hospital where the study
Imaging in Pediatrics “ was conducted, reference levels of radiation in the pediatric
population are low.

10. 180 ”Are Automated and Grammati 423 Moroccan FOREARM assessing bone age in children during puberty.
Visual Greulich and na Caucasian (MC)
PyleBased Methods Boitsios et children,both girls WRIST
Applicable to Caucasian al, and boys were
European Children With a retrospectively HAND
Moroccan Ethnic Origin studied, aged from 2
When Assessing Bone to 15 years
Age?” ,
11. 181 “HIGH-TECHNOLOGY ALBERTO The advantages of these devices are their simplicity, low
MEDICAL EQUIPMENT FUMAGAL cost, sufficient image resolution for diagnosis purposes,
MANAGEMENT: LI et al. good clinical efficacy, and flexibility to the situations of use.
IMPLEMENTATION OF A Nevertheless, radiographic technique has numerous
MULTIDISCIPLINARY limitations and constraints.
DOSSIER FOR
HUMANITAS RESEARCH
HOSPITAL”

12. 191 “Chest Radiography: A Igoh et al The study included Chest x-ray was normal in 68.9% of the subjects while 783
Review of 5 Year Findings ., 1039 females and (31.1%) patients showed various abnormal findings, like
in Peripheral Facilities in 1482 males. chest infection(20.1%) and hypertensive heart disease
Jos, North -Central (5.3%).Other findings include heart failure (1.5%),
Nigeria. “ hypertension(1.5%),pleural effusion(1.0%) and pulmonary
tuberculosis (0.6%).
13. 202 ” Association of serum Zhang, F 9741 participants CHEST X-RAY Their results indicated that the role of serum creatinine
creatinine with aortic et al, EXAMINATION levels in AAC and CVD development remains under
arch calcification in recognised and undertreated in the general population
middle-aged and elderly
adults: an observational
cross-sectional study
from China.”

4. Revision History
Revision Author Details
00 Dr. Bakki Sheshu Kumar Initial Version
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Clinical Evaluation Report of HF-400

SAAKSHI MEDTECH AND PANELS LIMITED DOC ID: HF 400/CED/01

Clinical Evaluation is a methodologically sound ongoing assessment of clinical performance

Table 1 Device Details

Table 2 Device, Components and Accessories.

Accessories Register 1. Patient Abdomen Binder

2.1 General Device Description of HF-400

Table 3 Unit overview

Table 4 Unit Overview (Part2)

Figure 1 Functional Diagram with cable details

2.3 Intended purpose of the device:

This includes standard radiography procedures such as:

2.3.2 Radiation Safety

2.3.3 Warnings and Precautions

2.3.4 Intended user

2.3.5 Clinical benefits:

2.3.7 Device Development plan

3.1 Conclusions of Risk Management

Risk Pre-Mitigation Hazards Post-Mitigation Hazards

After mitigation, there are no unacceptable risk in the device.

Risk Benefit Analysis and Overall Residual Risk Summary

Disclosure of Residual Risks/Side-Effects

6.1 Equivalent devices:

 BPL HRAD 32, BPL

The analysis and conclusions were identified in below table as:

 Same: No difference in characteristics between products

HF-400 BPL HRAD 32 Model - MX 32 HF MULTIX Impact Analysis and

Type of Control Digital Digital Digital Digital Same: No difference in

Power Output 32kW 32 kW 32 kW 55 kW Similar: No Clinical

Relative Humidity: Relative Humidity: Relative Humidity: 30%Operation Relative

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

5. Data Selection and considerations

 Pre clinical data

The clinical evaluation was based on the following elements

Data type Description Justification Data Source

IFU user manual is available (F/DOC/35) Standard

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

Radiation protective accessories is Tested,

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

6. Summary and appraisal of clinical data

6.1 Verfication and Validation activities

R6. Design Output Verification HF 400 SMTPL/DV/HF 400/01

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

6.2 Internal Vigilance Data

6.3 State of the art

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

efficient use of diagnostic and therapeutic radiography.

• the American Society of Emergency Radiology (ASER),

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

• the American Association of Physicists in Medicine (AAPM),

Rationale of choosing the data source

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

6.3.3 Radiation Safety in Imaging

6.3.4 Alternative imaging modalities to radiography: CT, Ultrasound and MRI

PREPARED BY: DR B SHESHU KUMAR MBBS MD - ֍ CERFINITY LTD. ֍

(Erstwhile known as Saakshi Machine and Tools Pvt Ltd)

Computed Tomography (CT)