Confidential

GE Healthcare

Senographe Essential
Clinical and Non-Clinical Information

Supplement to Operator Manual

5142237-100

Revision 1

Copyright 2006 by General Electric Co.

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ATTENTION

LES APPAREILS A RAYONS X SONT DANGEREUX A LA FOIS POUR LE PATIENT ET POUR LE MANIPULATEUR SI LES
MESURES DE PROTECTION NE SONT PAS STRICTEMENT APPLIQUEES
Bien que cet appareil soit construit selon les normes de sécurité les plus sévères, la source de rayonnement X représente un danger lorsque le
manipulateur est non qualifié ou non averti. Une exposition excessive au rayonnement X entraîne des dommages à l’organisme.
Par conséquent, toutes les précautions doivent être prises pour éviter que les personnes non autorisées ou non qualifiées utilisent cet appareil créant
ainsi un danger pour les autres et pour elles-mêmes.
Avant chaque manipulation, les personnes qualifiées et autorisées à se servir de cet appareil doivent se renseigner sur les mesures de protection
établies par la Commission Internationale de la Protection Radiologique, Annales 26 : Recommandations de la Commission Internationale sur la
Protection Radiologique et les normes nationales en vigueur.

WARNING
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR
UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED
Though this equipment is built to the highest standards of electrical and mechanical safety, the useful x-ray beam becomes a source of danger in the
hands of the unauthorized or unqualified operator. Excessive exposure to x-radiation causes damage to human tissue.
Therefore, adequate precautions must be taken to prevent unauthorized or unqualified persons from operating this equipment or exposing themselves
or others to its radiation.
Before operation, persons qualified and authorized to operate this equipment should be familiar with the Recommendations of the International
Commission on Radiological Protection, contained in Annals Number 26 of the ICRP, and with applicable national standards.

ATENCION
LOS APARATOS DE RAYOS X SON PELIGROSOS PARA EL PACIENTE Y EL MANIPULADOR
CUANDO LAS NORMAS DE PROTECCION NO ESTAN OBSERVADAS
Aunque este aparato está construido según las normas de seguridad más estrictas, la radiación X constituye un peligro al ser manipulado por personas
no autorizadas o incompetentes. Una exposición excesiva a la radiación X puede causar daños al organismo.
Por consiguiente, se deberán tomar todas las precauciones necesarias para evitar que las personas incompetentes o no autorizadas utilicen este aparato,
lo que sería un peligro para los demás y para sí mismas.
Antes de efectuar las manipulaciones, las personas habilitadas y competentes en el uso de este aparato, deberán informarse sobre las normas de
protección fijadas por la Comisión Internacional de la Protección Radiológica, Anales No 26: Recomendaciónes de la Comisión Internacional sobre la
Protección Radiológica y normas nacionales.

ACHTUNG
RÖNTGENAPPARATE SIND EINE GEFAHR FÜR PATIENTEN SOWIE BEDIENUNGSPERSONAL,
WENN DIE GELTENDEN SICHERHEITSVORKEHRUNGEN NICHT GENAU BEACHTET WERDEN
Dieser Apparat entspricht in seiner Bauweise strengsten elektrischen und mechanischen Sichereitsnormen, doch in den Händen unbefugter oder
unqualifizierter Personen wird er zu einer Gefahrenquelle. Übermäßige Röntgenbestrahlung ist für den menschlichen Organismus schädlich.
Deswegen sind hinreichende Vorsichtsmaßnahmen erforderlich, um zu verhindern, daßunbefugte oder unqualifizierte Personen solche Geräte
bedienen oder sich selbst und andere Personen deren Bestrahlung aussetzen können.
Vor Inbetriebnahme dieses Apparats sollte sich das qualifizierte und befugte Bedienungspersonal mit den geltenden Kriterien für den gefahrlosen
Strahleneinsatz durch sorgfältiges Studium des Hefts Nr. 26 der Internationalen Kommission für Strahlenschutz (ICRP) vertraut machen:
Empfehlungen der Internationalen Kommission für Strahlenschutz und anderer nationaler Normenbehörd

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REVISION HISTORY

REV DATE REASON FOR CHANGE

1 June 15, 2006 Part of final printed labeling following PMA approval
Released for Sirius M3

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TABLE OF CONTENTS

INTRODUCTION 1

INDICATIONS FOR USE 2

CONTRAINDICATIONS 2

WARNINGS AND PRECAUTIONS 2

POTENTIAL ADVERSE EFFECTS 2

SUMMARY OF CLINICAL STUDIES OF THE SENOGRAPHE 2000D 3

HARDCOPY CLINICAL STUDIES OF THE SENOGRAPHE 2000D 3

A. Study Design and Objectives 3

B. Study Population 3

C. Demographics 3

D. Image Acquisition and Interpretation 4

E. Cancer Stage and Size Distribution 4

F. ROC Curve Results 4

G. Sensitivity Results 5

H. Specificity Results 5

I. Side-by-Side Feature Comparison 6

J. Safety 6

K. Conclusions 6

SOFTCOPY CLINICAL STUDY OF THE SENOGRAPHE 2000D 7

A. Study Design and Objectives 7

B. Study Population 7

C. Demographics 7

D. Image interpretation 7
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E. Results 8

F. Conclusion 8

NON-CLINICAL STUDIES OF THE SENOGRAPHE ESSENTIAL 9

A. Imaging area 9

B. Dynamic Range and Sensitometric Response 9

C. Detective Quantum Efficiency (DQE) 9

D. DQE versus Exposure Level - Quantum-Limited performance 10

E. Conclusions 11

CLINICAL STUDIES OF THE SENOGRAPHE ESSENTIAL 12

LFOV IMAGES REVIEW CLINICAL STUDY 12

A. Study Design and Objectives 12

B. Study Population 12

C. Image interpretation 12

D. Results 13

E. Conclusion 13

IMPACT OF THE USE OF A LARGE FIELD OF VIEW DETECTOR FOR SMALL

BREASTED WOMEN 14

A. Study Design and Objectives 14

B. Study Population 14

C. Image interpretation 14

D. Results 14

Conclusion 16

CONFORMANCE TO STANDARDS 17

TRAINING PROGRAM 18

OPERATOR MANUAL/DIRECTIONS FOR USE 22

PRODUCT COMPLAINTS 22
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INTRODUCTION

The Senographe Essential System has evolved from the Senographe DS System, which evolved from the Senographe
2000D (Full Field Digital Mammography). The Senographe Essential is designed to image both small and large breasts.
FDA approved this device through a supplement to the original premarket approval application (“PMA”) for the
Senographe 2000D System (P990066).

This document contains the summaries of the clinical and non-clinical studies of the Senographe 2000D included in the
FDA approved labeling for that device. Those studies provide useful information about the performance of the
Senographe Essential when used in the 19 x 23 cm field of view (“FOV”) mode because it covers the same area as the
Senographe DS and Senographe 2000D’s 19 x 23 cm FOV detectors. The modifications incorporated into the
Senographe Essential are designed to enhance the device’s performance. Those modifications include 1°) a larger
detector (24x31 cm); 2°) the use of FineView processing for all clinical images; and 3°) a higher detector DQE. Based
on the technical characteristics of the Senographe Essential system and the results of the non clinical observer
performance studies summarized in the PMA supplement for this device, the clinical performance of the Senographe
Essential is equivalent to or better than the clinical performance of the Senographe 2000D. The additional studies
performed on the Senographe Essential, which are also summarized below, confirm that this device is safe and effective
for imaging both small and large breasts with its 24 x 31 cm FOV.

CAUTION: United States Federal law restricts this device to use by or on the order of a
physician.

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INDICATIONS FOR USE

The Senographe Essential system generates digital mammographic images, which can be used for screening and
diagnosis of breast cancer.

The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic
film/screen systems.

CONTRAINDICATIONS
There are no known contraindications.

WARNINGS AND PRECAUTIONS

The user should refer to the Operator Manual for directions on how to use the Senographe Essential system.

POTENTIAL ADVERSE EFFECTS

The user should refer to the Operator Manual.

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SUMMARY OF CLINICAL STUDIES OF THE SENOGRAPHE 2000D

The hardcopy and softcopy clinical studies of the Senographe 2000D are summarized below.

HARDCOPY CLINICAL STUDIES OF THE SENOGRAPHE 2000D

A. STUDY DESIGN AND OBJECTIVES

A multi-center clinical trial comparing full field digital mammography with the Senographe 2000D to screen-film
mammography (SFM) was conducted in the United States.

The objective of the study was to test whether the Senographe 2000D was non-inferior compared to SFM in a mixed
diagnostic and screening population. Sensitivity, receiver operating characteristics (ROC), and specificity analyses
were performed. A side-by-side feature comparison was also performed.

B. STUDY POPULATION
Women aged 40 or older attending for diagnostic mammography were included in the study. Women were excluded
from the study if they were pregnant or suspicious of being pregnant; had breast implants; had breasts too large to be
adequately positioned on a 24 x 30 cm screen -film receptor; had non-focal or bilateral breast pain; or who were unable
or unwilling to execute the consent form.

Six hundred twenty-five (625) women (44 cancer cases and 581 non-cancer cases) were included in the study cohort.
Cancer cases were identified from a diagnostic cohort and a screening cohort. The diagnostic cohort consisted of 605
women presenting for diagnostic mammography at four sites [the University of Colorado Health Sciences Center
(UCHSC), the University of Massachusetts Medical Center (UMMC), Hospital of the University of Pennsylvania
(HUP), and Massachusetts General Hospital (MGH)]. This population included 24 diagnostic cancer cases. The
screening cohort consisted of 20 consecutive cancer cases generated from a screening population of over 4,000 women.
The screening cohort was conducted at UCHSC and UMMC.

Fifty-five percent (55%) (24/44) of the cancer cases in the study cohort were derived from a diagnostic population and
forty-five percent (45%) (20/44) were derived from a screening population. The study population provided adequate
information about use of the device in a diagnostic population and provides additional information about use of the
device in a screening population. While this study cohort was a mixture of diagnostic patients and screening cancers,
the distribution of cancer stages and sizes was not statistically different from that of a screening population.

C. DEMOGRAPHICS
The average age for the women in the study was 55 years with a range from 40-86 years. Eighty-five percent (85%) of
the women were white, 8% were African-American, 2% Hispanic, 1% Asian, and 4% unknown. Thirty-four percent
(34%) of the women reported a history of breast-related medical diseases or conditions and 33% reported a history of
hormone replacement therapy.

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D. IMAGE ACQUISITION AND INTERPRETATION

Two views, craniocaudal (CC) and mediolateral oblique (MLO), of each breast were acquired by each modality using
GE Medical Systems’ (GE Healthcare) Senographe 2000D system with equal or slightly lower breast doses than SFM.
Equivalent target-filter, kVp, and equal or slightly lower mAs values were used on the Senographe 2000D. The same
technologist performed both the Senographe 2000D and SFM imaging with similar positioning and compression forces.
Fifty-nine percent (59%) were bilateral exams and 41% were unilateral exams.

Five MQSA-qualified radiologists independently interpreted each SFM and Senographe 2000D image. The radiologists
had no prior knowledge of the cases. Senographe 2000D images were stored digitally and printed at UCHSC and
UMMC to provide comparability to SFM. Each radiologist interpreted half the SFM cases first and half the Senographe
2000D cases first, with at least 30 days between interpretations of the same case from each of the two modalities. For
each case, the radiologist provided BIRADS categories (0, 1, 2, 3, 4, or 5) and a probability of cancer on a 0-100%
scale for BIRADS 0, 3, 4, and 5 breasts.

E. CANCER STAGE AND SIZE DISTRIBUTION

Sixty-one percent (61%) of the cancers in the study were Stage 0 or I. Thirty-nine percent (39%) were Stages II, III,
and IV. Forty-three percent (43%) of the cancers were less than or equal to 1 cm; fifty-seven percent (57%) of the
cancers larger than 1 cm.

The Agency for Health Care Policy and Research (AHCPR) Clinical Practice Guidelines recommend that in a good
mammography program at least 50% of detected cancers should be Stage 0 or I and at least 30% of detected cancers
should be less than or equal to 1 cm in size. The percentage of Stage 0 and I cancers in this study exceeded the AHCPR
guideline for Stage 0 and I cancers by 11% and exceeded the AHCPR guideline for small cancers by 13%.

F. ROC CURVE RESULTS

ROC curves were constructed from all cases assigned a BIRADS code of 0, 3, 4, or 5, using independent interpretations
of Senographe 2000D and SFM based on the probabilities of cancer (on a 0-100% scale). ROC curve areas were 0.722
for Senographe 2000D versus 0.723 for SFM.

Based on the 95% confidence interval for the difference between ROC curve areas, the ROC curve area of Senographe
2000D could be as much as 0.073 below, to as much as 0.055 above, that of SFM. Thus, the null hypothesis that the
ROC curve area of Senographe 2000D was lower than that of SFM by more than 0.10 was rejected (p<0.0001).

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R e a d e r S tu d y # 2 : R O C C u rv e s fo r A ll 5 R e a d e rs C o m b in e d
B re a s t b y B re a s t A n a ly s is
1

0 .9

0 .8

0 .7
True Positive Fraction

0 .6

0 .5
F F D M R O C A re a = 0 .7 2 2
0 .4 S F M R O C A re a = 0 .7 2 3

0 .3

0 .2

0 .1

0
0 0 .1 0 .2 0 .3 0 .4 0 .5 0 .6 0 .7 0 .8 0 .9 1

F a ls e P o s itiv e F ra c tio n

FIGURE 1

G. SENSITIVITY RESULTS
A comparison was made of the fraction of total cancers among the study cohort that were detected by Senographe
2000D and SFM, giving an estimated sensitivity for each modality. For all cancer stages and sizes, the sensitivity was
68% for Senographe 2000D compared to 70% for SFM, for all cancer stages and sizes.

Based on the 95% confidence interval for the difference in sensitivities, the sensitivity of Senographe 2000D could be
as much as 9.96% below, to as much as 7.24% above, that of SFM. Thus the null hypothesis that the sensitivity of
Senographe 2000D was lower than that of SFM by more than 10% was rejected (p=0.0245).

H. SPECIFICITY RESULTS
Specificity was 55% for Senographe 2000D versus 53% for SFM, for all cancer stages and sizes. Thus the recall rate in
this study for lesions that turned out to be benign was 45% for Senographe 2000D versus 47% for SFM.

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Based on the 95% confidence interval for the difference in specificities, the specificity of Senographe 2000D could be
as much as 0.58% below, to as much as 4.36% above, that of SFM. Thus the null hypothesis that the specificity of
Senographe 2000D was lower than that of SFM by more than 5% was rejected (p<0.001).

I. SIDE-BY-SIDE FEATURE COMPARISON

The side-by-side feature analysis comparison included 40 cancer cases. All 40 cases had MLO comparisons and 39 had
CC comparisons for a total of 79 views. Both Senographe 2000D and SFM images were placed on the same
mammography alternator or bank of view boxes. Five (5) independent MQSA-qualified radiologists evaluated lesion
conspicuity, inclusion of tissue along the chest wall, and visibility of tissue at, or near, the skin line of the breast using
an 11-point Likert scale (0-4 favoring Senographe 2000D, 5 equally visible on Senographe 2000D and SFM, 6-10
favoring SFM). An overall mean value was calculated across all readers and views.

For visibility near the skin line, readers could see tissue at the skin line better with Senographe 2000D than with SFM
(mean value of 2.95). Lesion conspicuity and tissue at the chest wall were equally visible with mean values of 5.17 and
5.21, respectively. Readers could, on average, discriminate calcifications, masses, architectural distortions, and focal
asymmetry equally well on Senographe 2000D and SFM.

J. SAFETY
No adverse consequences (serious or otherwise) were reported for patients enrolled during the study.

K. CONCLUSIONS
Data derived from clinical trials, in conjunction with preclinical data on the physical parameters of the system, show
that the Senographe 2000D system is safe and effective for use in screening and diagnosis of breast cancer.

The ROC curve areas for the Senographe 2000D and SFM systems are virtually identical.

The sensitivity analysis demonstrated that the Senographe 2000D has sensitivity comparable to that of SFM in the
screening and detection of breast cancer.

The specificity analysis demonstrated that the Senographe 2000D system results in fewer women being recalled than
SFM.

The side-by-side feature comparison data demonstrated that the Senographe 2000D system allows better visibility of
tissue at the skin line than SFM and that the Senographe 2000D system is comparable to SFM for lesion conspicuity
and visibility of tissue at the chest wall.

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SOFTCOPY CLINICAL STUDY OF THE SENOGRAPHE 2000D

A. STUDY DESIGN AND OBJECTIVES

A multi-center clinical trial of the Senographe 2000D full field digital mammography (FFDM) device was conducted in
the United States.

The objective of the study was to test the comparability of softcopy displayed full-field digital mammography (FFDM)
to hardcopy displayed FFDM using the Senographe 2000D.

B. STUDY POPULATION
The cases used in this softcopy comparison consisted of a subset of cases generated in the pre-market approval (PMA)
hardcopy FFDM study. One hundred eight (108) cases (all 44 confirmed cancers and a sample of 64 benign lesions
from the study cohort for Reader Study #2 from PMA #P990066) were reviewed. All views acquired of the lesion in
question were evaluated in a side-by-side comparison of softcopy FFDM and hardcopy FFDM.

C. DEMOGRAPHICS
The average age for the women in the study was 58 years with a range from 40-84 years. Ninety percent (90%) of the
women were white, 7% were African-American, 1% Asian, 2% other and 2% unknown. Thirty-two percent (32%) of
the women reported a history of breast-related medical diseases or conditions and 35% reported a history of hormone
replacement therapy.

D. IMAGE INTERPRETATION
The softcopy display system used in this study was a GE Senographe 2000D Review Workstation designed specifically
for display of digital mammograms.

Craniocaudal (CC) and mediolateral oblique (MLO) views of the breast containing the lesion were scored
independently for each lesion feature by five radiologists, without information provided about whether the lesion was
cancer. The five participating radiologists were MQSA-qualified and experienced in using the Senographe 2000D
Review Workstation. Each radiologist performed the side-by-side comparison independently.

For each view of each lesion, all five radiologists were asked to identify the primary and all secondary lesion features.
Each identified lesion feature was then scored for comparative conspicuity in hardcopy vs. softcopy FFDM images
using an 11-point Likert scale ranging from 0 (lesion feature was visible only on softcopy FFDM) to 10 (lesion feature
was visible only on hardcopy FFDM). A score of 5 was assigned if the lesion feature was judged to be equally visible
on softcopy and hardcopy FFDM.

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E. RESULTS
Overall side-by-side comparisons for the CC and MLO views individually demonstrated rejection of the null hypothesis
with a high degree of statistical significance (p < 0.0001), indicating that Senographe 2000D softcopy display of FFDM
is comparable to hardcopy display.

Side-by-side comparisons for individual readers and for individual lesion types demonstrated rejection of the null
hypothesis with a high degree of statistical significance (p < 0.0001), indicating that Senographe 2000D softcopy
display of FFDM is comparable to hardcopy display.

Side-by-side comparisons for individual lesion types for cancer cases and non-cancer cases demonstrated rejection of
the null hypothesis with a high degree of statistical significance (p < 0.0001), indicating that Senographe 2000D
softcopy display of FFDM is comparable to hardcopy display.

In each analysis, the majority of mean preference scores demonstrated a preference for softcopy display of Senographe
2000D FFDM images for each lesion type and view.

Among readers expressing a preference, the majority preferred softcopy display of images on the Senographe 2000D
system, with the most common reason for preference being a difference in contrast between the lesion and surrounding
tissues.

F. CONCLUSION
Data derived from this clinical trial demonstrate comparable quality of digital mammograms by softcopy or hardcopy
display. Where preference was expressed, radiologists preferred softcopy display using the Senographe 2000D Review
Workstation. Therefore, these data demonstrate the effectiveness of softcopy display provided by the Senographe
2000D system for primary interpretation of screening and diagnostic mammography.

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NON-CLINICAL STUDIES OF THE SENOGRAPHE ESSENTIAL

A. IMAGING AREA
The new detector for Senographe Essential features a sensing area of 307.2 mm along the chest wall axis and 240.0 mm
along the axis perpendicular to the chest wall. The image size is 3062 pixels (306.2 mm) along the chest wall axis and
2394 pixels (239.4 mm) along the axis perpendicular to the chest wall.

The non-imaging distance between the outer surface of the Bucky and the first imaging column is inferior to 5.0 mm on
the chest wall side. The non-imaging distance on each lateral side between the outer surface of the Bucky and the first
imaging row is inferior to 36 mm.

B. DYNAMIC RANGE AND SENSITOMETRIC RESPONSE

The detector exhibits a response that is linear over a range of 0 to over 210 mR at the breast support surface.

Detector Signal vs. Exposure at Detector Surface

16000

Signal
14000
Linear Fit

12000
Signal (counts)

10000

8000

6000

4000

2000

0
0 30 60 90 120 150 180 210 240 270
Exposure (mR)

FIGURE 1: DIGITAL DETECTOR RESPONSE

C. DETECTIVE QUANTUM EFFICIENCY (DQE)

DQE measures the efficiency by which a system transfers signal and noise. It is defined as the ratio of the square of
output signal-to-noise ratio (SNR) to the square of input SNR. Since the output SNR is a measure of the displayed
image quality and the input SNR can be related to patient dose, DQE can be considered as a ratio of image quality to
patient dose. Doubling DQE means that one gets the same image quality at half the dose or a 40% improvement in
image quality for the same dose.

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SNR 2 at detector output Image Quality

DQE = ∝
SNR 2 at detector input Patient Dose

D. DQE VERSUS EXPOSURE LEVEL - QUANTUM-LIMITED PERFORMANCE

The detector of the Senographe Essential not only exhibits a linear signal response over a wide exposure range, it also
exhibits a quantum-limited noise response. Quantum-limited response is evidenced by image noise variance (the square
of the standard deviation of the pixel values within a region of interest) that increases linearly with the exposure to the
detector.

Noise Variance of Offset Corrected Image vs. Exposure

700

600
Noise Variance
Noise Variance (counts)^2

500 Linear Fit

400

300

200

100

0
0 50 100 150 200 250
Exposure (mR)

FIGURE 2: IMAGE NOISE VS. EXPOSURE FOR THE SENOGRAPHE ESSENTIAL

At low exposure levels, the plot of image noise variance vs. exposure intercepts the y axis at the level of electronic
noise in the imaging system.

The combination of linear signal response and quantum-limited noise response leads to a DQE that is independent of
exposure level over a broad range of exposures. Unlike screen-film systems, which tend to have low DQE at high film
densities (near the skin line) and at low film densities (in the image of glandular tissue or near the chest wall), the
Senographe Essential provides uniformly high DQE throughout the mammogram. This provides a probability of
detection of an abnormality that is less dependent on its location than is the case for screen-film detectors.

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DQE vs. Exposure at Three Spatial Frequencies

0.8

0.7

0.6

0.5
DQE

0.4

0.3

0.2 0.5lp/m
2.0lp/mm
0.1 5.0lp/mm

0.0
0 20 40 60 80 100
Detector Exposure (mR)

FIGURE 3: DQE VS. EXPOSURE AT THREE SPATIAL FREQUENCIES

DQE is essentially independent of exposure for exposures at the detector plane greater than about 5 mR. Therefore, the
DQE of Senographe Essential has little dependence on the exposure level for the clinical exposure range.

E. CONCLUSIONS
The combination of linear signal response and quantum-limited noise response leads to a DQE that is independent of
exposure level over a broad range of exposures. Unlike screen-film systems, which tend to have low DQE at high film
densities (near the skin line) and at low film densities (in the image of glandular tissue or near the chest wall), the
Senographe Essential provides uniformly high DQE throughout the mammogram. This provides a probability of
detection of an abnormality that is less dependent on its location than is the case for screen-film detectors. This was
shown to be true by the side-by-side feature comparison (see subsection I of this section).

The Senographe Essential has wider exposure latitude and higher DQE compared to Senographe 2000D, allows for
electronic archival transmission and image manipulation, and involves shorter examination time. The ability to
manipulate images has the potential to eliminate the need for additional magnification of views. Similarly, windowing
and leveling can compensate for exposure variations eliminating the need for repeated exposures or exposures adjusted
to specifically view the skin line or the chest wall.

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CLINICAL STUDIES OF THE SENOGRAPHE ESSENTIAL

The Senographe Essential features a large field of view detector (24x31 cm) and offers compression paddles to
accommodate different breast sizes.

LFOV IMAGES REVIEW CLINICAL STUDY

A. STUDY DESIGN AND OBJECTIVES

A multi-center clinical trial of the Senographe Essential full field digital mammography (FFDM) device was conducted.

The objective of the study was to compare the Senographe Essential softcopy and hardcopy review when magnification
glass (electronic with softcopy, optical with hardcopy) and one display pixel representing one detector pixel (“1:1
mode”) were used for the softcopy review.

B. STUDY POPULATION
The cases used in this reader study consisted of a subset of cases generated during the external evaluation of the
Senographe Essential. A set of 57 cases was reviewed. The cases were selected from among a database of cases already
diagnosed through a standard diagnostic procedure, which included the review of four basic views of both breasts and
additional work-up when needed. These cases were selected based on the findings reported by the radiologists who
made the diagnoses. Obvious lesions were excluded. Cases showing subtle microcalcifications were selected because
they present the biggest reviewing challenge. Cases with a thin and subtle fiber structure were included. The cases
selected included at least 15 with microcalcifications, 20 with masses or focal densities, and four showing an
architectural distortion as a primary or secondary lesion.

C. IMAGE INTERPRETATION
Softcopy review was done in the following order: (1) Fit To Screen; (2) Fit To Screen with electronic mag glass;
(3) 1:1 mode; and (4) 1:1 mode with mag glass. “Fit to Screen” (FTS) means that the size of the mammogram was
scaled to optimally use the available area of the display. Hardcopy review was done without mag glass and then with
an optical mag glass. The readers recorded the BIRAD assessment, type of lesion, and the reader’s confidence level
regarding the assessment for each of those combinations of review modes and viewing tools.

Three experienced and MQSA-qualified radiologists reviewed the Senographe Essential hardcopy and softcopy images
for a set of 57 cases. Each reader participated in two reading sessions. All 57 cases were reviewed during each session.
However, the order in which a radiologist reviewed the softcopy and hardcopy images (first or second session) for an
individual case was randomized. At least a week elapsed between each radiologist’s review of the softcopy and
hardcopy images.

Each case consisted of two images of the same breast (Cranio-Caudal (“CC”) view and Medio-Lateral Oblique
(“MLO”) view)

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D. RESULTS
There is a trend for fewer negative findings (BIRAD=1) with a corresponding increase in benign findings (BIRAD=2)
with softcopy 1:1 (p=0.06) and softcopy FTS (p=0.11).

The radiologists were slightly less confident in their softcopy FTS than their hardcopy assessment, but these
assessments were still substantially equivalent (95% confidence interval on the difference in confidence of assessment
is (-0.9, 5.0). More negative favors softcopy).

The radiologists were slightly more confident in their softcopy 1:1 assessment than their hardcopy assessments. (95%
confidence interval on the difference in confidence of assessment is (-5.2, 0.7). More negative favors softcopy).

There was a significant difference in confidence depending on whether the mag glass tool was used or not (p<0.0001).
The radiologists were more confident about their assessments when they used the mag glass tool for hardcopy
(p<0.0001) and softcopy FTS (p<0.0001) but there was no difference for softcopy 1:1 (p=0.2374).

There was a significant difference in average BIRAD assessment depending on whether the mag glass tool was used or
not (p=0.0091). The softcopy 1:1 (p=0.7863) and hardcopy (p=0.2012) average BIRAD scores were the same whether
or not the mag glass was used. The softcopy FTS average BIRAD scores were significantly higher with the mag glass
tool (p=0.0111). The softcopy 1:1 was better than softcopy FTS without the mag glass tool. Softcopy 1:1 average
BIRAD assessments were the same for softcopy FTS with the mag glass tool. Softcopy 1:1 was higher than hardcopy
regardless of whether either system used the mag glass tool.

E. CONCLUSION
That study showed that the optimal reading condition for the Senographe Essential softcopies is to review images in
FTS and then to use any DICOM standard tool, e.g., electronic magnification or window and level adjustment. The test
also showed that the 1:1 display can be used to increase confidence in the review, but it is not necessary to use that tool
to match hardcopy performance.

For softcopy diagnostic interpretation, images shall be reviewed on an approved Digital Imaging and Communications
in Medicine (DICOM)-compatible review workstation with 5 Mpixel screens.

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IMPACT OF THE USE OF A LARGE FIELD OF VIEW DETECTOR

FOR SMALL BREASTED WOMEN

A. STUDY DESIGN AND OBJECTIVES

A reader study was conducted to confirm that imaging small-breasted women on a large detector impacts neither
positioning nor image quality.

The same set of patients was imaged on both Senographe DS featuring a 19x23 detector, and Senographe Essential
featuring a 24x31 cm detector.

B. STUDY POPULATION
A total of 42 cases were enrolled but five cases were not included in the analysis because a different image processing
was used in those cases.

C. IMAGE INTERPRETATION
Three experienced, MSQA-qualified mammography radiologists conducted a side-by-side comparison of the
Senographe Essential and Senographe DS hardcopy images to evaluate overall breast positioning and image quality in
small breasts.

The radiologists reviewed all four images for all cases, which were all breasts that fit within a 19 x 23cm FOV and for
which there were four standard views per system. To limit variability, all patients were imaged at the same site by the
same technologist.

Each reader rated each set of images with respect to overall positioning and image quality on the same 7-point scale.

D. RESULTS

Overall Positioning of Small Breasts on the Senographe Essential

Radiologists characterized the positioning of small breasts with the Senographe Essential to be the same or “slightly
better” than the Senographe DS in 93.7% of the cases. At most, the radiologists slightly preferred either the
Senographe Essential or the Senographe DS for positioning certain breasts for they did not indicate that either system
was “better”, i.e., a score of +2 or -2, or “much better” i.e., a score of +3 or -3, in any case.

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Figure 11. Perception of Senographe Essential Overall Breast Positioning

Better 1

0.5

Same 0

-0.5

Worse -1
Right Display

Reader A

Reader B

Reader C
Left Display
Overall

All of the two-sided 95% confidence intervals for the difference in preference scores for the Senographe Essential and
the Senographe DS, with respect to positioning of small breasts are well above the -0.5 level and include the zero score,
which indicates that these systems are the “same” for small breast positioning. Thus, this test demonstrates the non-
inferiority of the Senographe Essential system compared to the Senographe DS in positioning small breasts

Overall Image Quality of Small Breasts Acquired on the Senographe Essential

Radiologists characterized overall image quality as the same or “slightly better” with the Senographe Essential than
with the Senographe DS in 91% of the cases. They did not indicate that image quality with either system was “ better”
or “much better” than with the other system for any case. The results of this comparison are shown graphically in the
figure below. Thus, at most, the radiologists slightly preferred either the Senographe Essential or the Senographe DS
for imaging small breasts.

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Figure 12. Perception of Senographe Essential Image Quality

Better 1

0.5

Same 0

-0.5

Worse -1

Reader A
Right Display

Reader B

Reader C
Left Display
Overall

All of the two-sided 95% confidence intervals for the difference in preference score for the Senographe Essential and
the Senographe DS with respect to image quality for small breasts are well above the -0.5 level and include the zero
score indicating that these systems are the “same” with respect to image quality. Thus, this test demonstrates the non-
inferiority of the Senographe Essential compared to the Senographe DS in imaging small breasts.

CONCLUSION

The results showed that the observers’ average perception for breast position and image quality is the same for both
systems with a 95% confidence interval. Thus, this study demonstrates that the Senographe Essential is at least as
effective as the Senographe DS with respect to overall positioning and image quality in small breasts.

In addition, there was no difference between the three readers’ assessments or arising from the side of the display with
respect to small breast positioning or image quality. The potential variability among readers does not affect the overall
assessment of these systems’ equivalence in positioning and overall image quality.

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CONFORMANCE TO STANDARDS

The GE Medical Systems Senographe Essential system meets the following standards:

IEC 60601-1: Medical electrical equipment - Part 1: General requirements for safety

IEC 60601-1-1: Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety
requirements for medical electrical systems

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard:
Electromagnetic compatibility - Requirements and tests

IEC 60601-1-3: Medical electrical equipment - Part 1: General requirements for safety 3. Collateral Standard: General
requirements for radiation protection in diagnostic X-ray equipment

IEC 60601-2-28: Medical electronic equipment - Part 2: Particular requirements for the safety of X-ray source
assemblies and X-ray tube assemblies for medical diagnosis.

IEC 60601-2-32: Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment
of X-ray equipment

IEC 60601-2-45: Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-
ray equipment and mammographic stereotactic devices

IEC 60601-1-4: Medical electrical equipment — Collateral Standard: programmable electrical medical systems.

CSA Std C22.2 No 601.1-M90: Medical electrical equipment - Part 1: General requirements for safety

UL Std 2601-1: Medical electrical equipment

IEC 60950: Information technology equipment - Safety - Part 1: General requirements. (for Review WorkStation)"

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TRAINING PROGRAM
Users must ensure that they receive training on the Senographe Essential with GE Medical Systems training programs
prior to use on patients. GE Medical Systems training programs will address the MQSA training regulations in product
labeling to ensure that prospective users are aware of the required eight hours of training for any technologist or
interpreting physician.

The Applications training for the Senographe Essential consists of a three day on-site visit to your facility by an
Applications Specialist. During this visit the Applications Specialist will focus primarily on how to perform a digital
mammography procedure. This training agenda produces the best results when you dedicate a core group of 3 to 5
technologists to full training session. It is also critical that the key Radiologists are available to participate in this
training. Physicists set up their own 8 hour training sessions. In addition, the patient schedule should be modified to
allow time for instruction.

The following pages show the recommended schedule.

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DAY 1 RECOMMENDED PROGRAM

Radiologic
Radiologis Physicist
Module Time Technologist
t Optional
s
Digital Detector
Teaches the history of the digital detector and 1 hour X X X
the process of the development.
Digital Mammography / Advanced Applications
Teaches techniques available with digital 1 hour X X X
mammography and the advanced procedures
available on the full field digital system.
Basic Operation / Application
Teaches basic operation of the Seno Essential
workstation and functions of the mouse, 1 hour X X X
keyboard and browser. Teaches the steps to
acquiring a full field digital acquisition.
Displaying Images
Focuses on the Seno Essential workstation
control panels. Exam functions: exam and 1 hour X X X
image selection, window / level adjustment,
measurement panel, graphics and film
composer.
Filming Images / Image Reprocessing
Teaches film composer set-up, drag and drop
filming and F-key functions. Teaches the 1 hour X X X
different reprocessing looks and the
characteristic criteria for each look when
reviewing selected images.
Principles / Terminology
Teaches the principles and terminology of the 1 hour X X X
digital detector.
Managing Images
Teaches the transfer of image data to the 1 hour X X X
workstation(s)/archive and the removal of
patient/image data from the system.
SenoAdvantage Work Station
Teaches the startup/shutdown procedure.
Teaches system functions: local browser, filters, 1 hour X X X
user preference, lock screen and keypad
functions.

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DAY 2 RECOMMENDED PROGRAM 6-8 PATIENTS

Radiologic Radiologis Physicist

Module Time
Technologist t Optional
Startup / Shutdown / Safety
Teaches the performance of the startup /
shutdown, recovery, safety stops and locks.
Teaches compression release during an
1 hour X X
emergency shutdown in the mammography
environment and outlines the cleaning
procedures for the system.
QAP
Teaches the QAP tests for the full field digital
system. Teaches the performance and
frequency of the tests. Teaches the
documentation, control limits and corrective
actions needed. Teaches the equipment 4 hours X X
required to perform the following tests: monitor
cleaning, flat field test, phantom IQ tests on
AWS, and printer, CNR test, MTF test, AOP
test, SNR test, visual check, repeat analysis,
compression force test and printer QC.
Tube Characteristics
Teaches the identification of target / filter
combinations and the effect they have on global 30 minutes X X
and local contrast. Identify the application of
each focal spot.
System Error and Status Messages
Focuses on the method of display for system
messages and error codes. Teaches the use of 30 minutes X X
the operator’s manual to interpret and
troubleshoot messages and error codes.
Selecting Techniques
Teaches AOP and Manual technique selection Taught
for multiple patients. Identifies the impact of during
parameter selection on image quality. X X
patient
Overviews the importance of compression and imaging
the definition of daN. Identifies the impact of
parameter selection on image quality.
Patient Imaging / Positioning
Provides an opportunity to apply newly learned
skills to clinical practice. Patient or volunteer 1 hour X X
exams should focus on basic and advanced
positioning techniques according to ACR
guidelines.

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DAY 3 RECOMMENDED PROGRAM 6-8 PATIENTS

Radiologic Radiologis Physicist

Module Time
Technologist t Optional
System Review
Provides an opportunity to review and discuss 30 minutes X X X
information provided on days one and two of
training.
Review Managing Images
Reviews the transfer of image data to the review 30 minutes X X X
workstation(s) and the removal of patient /
image data from the system.
Magnification
Discuss magnification set up and the principles 30 minutes X X
of magnification. Teaches various
magnification factors.
Review SenoAdvantage Workstation
Reviews the performance of startup / shutdown
and emergency shutdown. Teaches system 30 minutes X X X
functions: local browser, filters, user preference,
lock screen and keypad functions.
Patient Imaging / Positioning
Provides an opportunity to apply newly learned 6 hours X X
skills.

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OPERATOR MANUAL/DIRECTIONS FOR USE

The user should refer to the Operator Manuals for directions on how to use the Senographe Essential system.

PRODUCT COMPLAINTS
Any health care professional (e.g., customer or user of this system of products) who has any complaints or has
experienced any dissatisfaction in the quality, durability, reliability, safety effectiveness and/or performance of this
product, should notify GE Healthcare. If the device malfunctions and may have caused or contributed to a serious injury
of a patient, GE healthcare should be notified immediately by telephone, fax, or written correspondence.

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