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RD_K3ROS_DO_0015_User_Manual_EN_r2
User Manual
K3ROS version 1.0
November 2020
INCEPTO MEDICAL, 128 RUE LA BOÉTIE - 75008 PARIS – FRANCE Copyright 2020
support@incepto-medical.com
https://incepto-medical.com PAGE 3 OF 11
Table of Content
1. Identification of the manufacturer 5

2. About the user manual 5
2.1. Recipients of the manual ......................................................................................................... 7
2.2. Certification .............................................................................................................................. 7
3. Security information 7
3.1. Residual risks .......................................................................................................................... 7
3.2. Symbols ................................................................................................................................... 7
3.3. Acronyms ................................................................................................................................. 7
4. Generalities 8
4.1. Product presentation ............................................................................................................... 8
4.2. User profile .............................................................................................................................. 8
4.3. Supported images.................................................................................................................... 8
4.4. Use claims ............................................................................................................................... 8
4.5. Device classification ................................................................................................................ 9
4.6. Declaration of confidentiality .................................................................................................... 9
5. Use and interpretation of the K3ROS analysis 9
6. Maintenance 11
7. Contact 11
1. Identification of the manufacturer
The K3ROS software application is designed and manufactured by:
Incepto Medical
128 Rue de la Boétie – 75008 Paris – France
: November 2020
Version number: 1.0.
3760332080008 (UDI-DI)
E-mail : support@incepto-medical.com
Website : www.incepto-medical.com
2. About the user manual
This document constitutes a user manual for the product K3ROS. This manual is an integral part of the
K3ROS software application. It gives the user the necessary instructions to ensure proper usage of the
application.
Recommendations :
- K3ROS must be used exclusively by doctors who have read this manual. In the event of
uncertainty about the interpretation of present instructions, please contact Incepto Medical
using the information provided in section 1.
- The information included in this document is exclusively designed for duly authorized
personnel. Please read this manual carefully before using K3ROS.
Warnings:
- Warning 1: K3ROS must not be used in the following cases:
▪ Non validated population: patients younger than 16, OR who have a surgical
history, OR who have a metal artifact on their MRI, since K3ROS has not been
validated for these populations,
▪ Absence of T2 sequence or proton density with fat saturation, in the coronal,
sagittal and axial planes, encompassing the entirety of the volume of the knee
▪ Sequence in which the Field of View (FOV) contains both knees
▪ Patient belonging to a population group known to have knee specificities (for
example: anatomical variation)
▪ Images that come from an incompatible acquisition system
In the cases cited below, you will receive a warning explaining that the exam is not adapted to K3ROS
usage specifying the reason, and no algorithmic prediction will be provided:
- Presence of a metal artifact

- Absence of T2 sequence or proton density with fat saturation, in the coronal, sagittal and
axial planes, encompassing the entirety of the volume of the knee.
In the cases cited below, you will receive a warning explaining that the exam is not suitable for the
intended use of K3ROS, and algorithmic predictions will be provided:
- Images that come from an incompatible acquisition system.
In the cases cited below, K3ROS will not generate a report (neither warning, nor automated report):
- Images of an anatomy other than the knee

- Sequence in which the Field of View (FOV) contains both knees
- Patient is less than 16 years old
- Sequence with spacing greater than 5mm.
In the cases cited below, a report will be generated, but the user must be informed that K3ROS’s
performance will potentially be degraded:
- Surgical history
- Patient belonging to a population group known to have knee specificities (for example:
anatomical variation).
- Warning 2: Users must not rely entirely on K3ROS results and must systematically
analyse the images. Users must know that K3ROS does not detect all anomalies and
presents a sensitivity and specificity inferior to 100% (risks of false positives and false
negatives). Furthermore, K3ROS does not analyse all knee structures.
- Warning 3: To avoid all wrong interpretation of results, it is necessary to read the

instruction manual before using K3ROS.
- Warning 4: The only anatomical region analysed by K3ROS is the knee.
- Warning 5: K3ROS only functions with knee MRIs containing T2 sequences with fat
saturation or proton density with fat saturation in three axes (axial, sagittal and frontal).
- Warning 6: K3ROS is designed to detect “mechanical” lesions of ligament, meniscus

and cartilage structures. K3ROS is not designed to be used in contexts of inflammatory or
tumoral pathologies.
- Warning 7: Poor quality images that would not be interpretable by a radiologist must
not be analysed using K3ROS (movement, very low resolution, etc.).
- Warning 8: All maintenance operations must be performed by authorized personnel in

order to ensure the proper functioning of K3ROS.
Remark:
- The figures and screens presented in this manual have been selected for illustrative
purposes only and must not be interpreted as real representations of data or results.
2.1. Recipients of the manual

This manual is addressed to clinicians who wish to use the software application K3ROS.
The users, or “authorized personnel,” must understand the K3ROS instruction manual before using the
application.
2.2. Certification
The K3ROS software application is marked CE, conforming to the Directive 93/42/CEE regulations
related to medical devices.
3. Security information
3.1. Residual risks

No residual risks concerning the use of the device have been identified at this time.
3.2. Symbols
The following symbols may be present in the documentation:
CE Particular Read user manual Unique Device Date of production

conformity Manufacturer attention before use Identification
mark demanded
3.3. Acronyms
Acronym Definition
MRI Magnetic Resonance Imaging
DICOM Digital Imaging and Communications in Medicine
PACS Picture Archiving and Communication System
FOV Field of View
4. Generalities
4.1. Product presentation

K3ROS is a software application based on artificial intelligence and designed to be used as a tool in
knee MRI interpretation. Its usage is uniquely reserved to clinicians. The application helps to detect
anomalies in the following structures:
- ACL,
- Medial and lateral menisci,
- Medial collateral ligament,
- Cartilage of the patellofemoral, lateral femorotibial and medial femorotibial compartments.
K3ROS is capable of detecting, for each of these structures, the presence or absence of lesions, and
concerning the meniscal tears their migrated or non-migrated character. These results are automatically
generated in a unique report, in DICOM format, integrated into the radiologist’s work interface, and
appears as a supplementary “sequence” in the PACs.
K3ROS must not be used as a stand-alone diagnostic tool to determine treatment plans or recommend
further support to the patient.
4.2. User profile

K3ROS is designed to be used by a clinician. This clinician can be a radiologist, an orthopedic surgeon,
a rheumatologist, a sports doctor; the clinician must in any case understand the anatomy of the knee
and the sequences usually performed for knee MRIs.
4.3. Supported images

K3ROS is designed to receive T2 sequences with fat saturation or proton density with fat saturation as
input, in 2D or 3D.
4.4. Use claims

K3ROS is a tool used for knee MRI interpretation. It is capable of detecting “mechanical” lesions of
certain meniscus, ligament, and cartilage structures:
● Rupture (partial or complete) of the anterior cruciate ligament
● Meniscal tear and characterization of the migrated character or not of this tear
● Rupture (partial or complete) of the medial collateral ligament
● Presence of loss of cartilaginous substance
For this reason, K3ROS is designed to be used in post-traumatic or degenerative contexts; it must not
be used for tumoral or inflammatory pathologies.
K3ROS has been validated for the following population:
● Patient at least 16 years of age,

● Absence of surgical history,
● Absence of metallic artifact on MRI.
4.5. Device classification

K3ROS is classified as a class 1 medical device.
4.6. Declaration of confidentiality

K3ROS conforms to all aspects of general regulation of data protection (RGPD) guaranteeing the
highest confidentiality and security standards concerning identifiable personal information and patient
medical files.
5. Use and interpretation of the K3ROS analysis
K3ROS is directly integrated into the user interface, with an automatic transfer of data and automatic
communication of results. The results can be visualized in any viewer compatible DICOM.
For each structure, K3ROS’s predictions can be the following:
- ACL
o Normal
o Total or partial rupture
o Doubt on partial or total rupture.
- Medial and lateral meniscus

o Normal
o Tear. In the event of a tear, K3ROS will affirm whether this tear is:
▪ Migrated,
▪ Not migrated,
▪ Or doubt on migration.
o Doubt concerning meniscus tear.
- Medial collateral ligament

o Normal (including normal and signal modification such as chondromalacia)
o Significant lesion: grade 2 lesion () or grade 3() lésion de grade 2 (intra-ligamentous
hypersignal) ou de grade 3 (total rupture)
o Doubt concerning a lesion.
- Cartilage
o Normal
o Chondropathy (including any loss of cartilage)
The report generated by K3ROS is as follows:
The color code is as follows:
- Green: structures predicted as normal by K3ROS

- Red: structures predicted as abnormal by K3ROS
- Orange: K3ROS does not confirm the presence or absence of anomalies, described in the text
under the term “certain doubt.”
- Gray (not colored): the unanalyzes anatomic zones including:
o The posterior cruciate ligament,
o The lateral collateral ligament,
o Bone structures.
6. Maintenance
The software updates and periodical maintenance activities required for the product are performed
remotely with the radiologist information systems. Incepto will inform you before any periodical
maintenance activity.
7. Contact
In the event of a problem, or if you have a question related to the usage of K3ROS,
you can reach us at the following address:
or:
Incepto Medical
128 rue la Boétie
75008 Paris
France

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DocuSign Envelope ID: 8C5008F3-7C67-4916-AEB3-6393426185EA

1. Identification of the manufacturer 5

1. Identification of the manufacturer

The K3ROS software application is designed and manufactured by:

128 Rue de la Boétie – 75008 Paris – France

Version number: 1.0.

2. About the user manual

- Presence of a metal artifact

- Images that come from an incompatible acquisition system.

- Images of an anatomy other than the knee

- Warning 3: To avoid all wrong interpretation of results, it is necessary to read the

- Warning 4: The only anatomical region analysed by K3ROS is the knee.

- Warning 6: K3ROS is designed to detect “mechanical” lesions of ligament, meniscus

- Warning 8: All maintenance operations must be performed by authorized personnel in

2.1. Recipients of the manual

3.1. Residual risks

CE Particular Read user manual Unique Device Date of production

MRI Magnetic Resonance Imaging

DICOM Digital Imaging and Communications in Medicine

PACS Picture Archiving and Communication System

FOV Field of View

4.1. Product presentation

4.2. User profile

4.3. Supported images

4.4. Use claims

● Rupture (partial or complete) of the anterior cruciate ligament

● Rupture (partial or complete) of the medial collateral ligament

● Presence of loss of cartilaginous substance

K3ROS has been validated for the following population:

● Patient at least 16 years of age,

4.5. Device classification

4.6. Declaration of confidentiality

5. Use and interpretation of the K3ROS analysis

For each structure, K3ROS’s predictions can be the following:

- Medial and lateral meniscus

- Medial collateral ligament

The report generated by K3ROS is as follows:

The color code is as follows:

- Green: structures predicted as normal by K3ROS

128 rue la Boétie

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