The Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe Essential FFDM systems are intended to be used in the same clinical applications as traditional film-based mammographic systems.

Premium View is an image-processing algorithm, which increases the visibility of breast structures. The main advantage is to provide a single breast image, where the contrast in the fatty tissues is similar to that obtained by setting WW (window width) and WL (window level) for optimum visualization of fatty tissues, and the contrast in the fibro-glandular tissue is similar to that obtained by setting WW and WL for optimal visualization of fibro-glandular tissues.

PVi is an option that can simplify the presentation of mammographic images, improve workflow, and streamline the review process of images with very dark or bright areas by presenting the image with the WW and WL optimized for review with minimal need for the user to make adjustments for the various tissue areas. This could be especially useful with patients who have very thin breasts, very dense breasts, or implants that currently require multiple adjustments of WW and WL to review.

eContrast accommodates different customer display preferences in screening and diagnosis, with 5 different levels, while keeping the PV i option for implants. eContrast postprocessing is also available for stereo images.

Device Description

The subject of this submission is a software-only option to Senographe Essential Full Field Digital Mammography (FFDM) system called eContrast. eContrast is an image post-processing algorithm that will introduce a modification to the previously approved Premium View (PV) / Premium View i (PVi) (K110798). eContrast processing will offer 6 levels of contrast strength for image viewing, where the desired combination of image sharpness, image smoothness, level of tissue penetration, and level of contrast may be selected by the radiologist. The final image appearance varies according to the selected level. eContrast is a Software only option.

AI/ML Overview

The provided text describes the GE Healthcare eContrast software option, an image post-processing algorithm for Full Field Digital Mammography (FFDM) systems. The study detailed is a clinical evaluation to determine the clinical acceptance of images processed with this algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in a readily quantifiable format (e.g., specific AUC values, sensitivity, specificity thresholds, or reader improvement percentages).

Instead, the clinical evaluation's objective was to "determine if the images retrospectively processed with the new processing still provided acceptable clinical image quality." This indicates a qualitative assessment of clinical acceptance rather than a quantitative performance metric.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The evaluation was based on patients with:
- Two fatty breasts
- Two dense breasts
- Two images that were "in between" (referring to breast density).
- The total number of patients or images is not explicitly stated, but it seems to be a small, representative set (presumably 6 images or 6 sets of images representing these categories).
Data Provenance: The images were acquired from patients classified as BIRADS 1 or 2 (which typically means normal or benign findings), ensuring a range of breast densities. The origin country is not specified, but GE Healthcare is a multinational company with a French submitter address. The study was retrospective, as it involved "retrospectively processed" images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify:

The exact number of experts (it mentions "radiologist" in the device description, implying radiologists are the end-users and implicitly the experts for this type of image review).
Their specific qualifications or years of experience.

The evaluation's objective was about "clinical acceptance," suggesting radiologists likely made these judgments.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. Given the focus on "clinical acceptance" by radiologists, it's implied that radiologists reviewed the images, but how their opinions were combined or adjudicated (e.g., consensus, majority vote) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The study described is a "clinical image evaluation" to assess the "clinical acceptance" of images processed with eContrast. It does not mention a comparative effectiveness study involving human readers with and without AI assistance, nor does it provide an effect size for human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The study's objective was to determine if retrospectively processed images "still provided acceptable clinical image quality," which implies a human reviewer interacting with the processed images. Therefore, a purely standalone (algorithm-only) performance evaluation in terms of clinical decision-making was not presented for regulatory purposes. The eContrast is an image post-processing algorithm, and its output is intended for human interpretation.

7. The Type of Ground Truth Used

The ground truth used was based on clinical acceptance of image quality by (presumably) radiologists. The study did not rely on pathology, outcomes data, or a pre-established consensus on disease presence/absence, but rather on the subjective assessment of whether the processed image quality was acceptable for clinical review. The selection criteria of BIRADS 1 or 2 patients suggests that the "ground truth" for the cases themselves was their benign status, but the evaluation was on the acceptability of the image processing.

8. The Sample Size for the Training Set

The document does not specify the sample size used for training the eContrast algorithm. eContrast is described as an "image post-processing algorithm" and its "Technology" section describes specific image manipulation steps (Collimator Detection, Pseudo-log Transformation, Thickness Equalization, Dynamic Range Management, Auto-contrast), which might be rule-based or involve learned parameters. If machine learning was used for any of these steps, the training data size is not provided.

9. How the Ground Truth for the Training Set Was Established

As the document does not specify a training set or a machine learning-based approach requiring ground truth in the traditional sense (e.g., for classification tasks), it does not describe how ground truth for a training set was established. It appears to be an image processing algorithm designed to enhance image features based on predefined criteria for contrast and sharpness, rather than a diagnostic algorithm that predicts disease.

Summary

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Image /page/0/Picture/0 description: The image shows a document with handwritten text. The text at the top reads "K131885 Page 1 of 4". In the lower left corner, there is a logo that appears to be the GE logo. The document seems to be the first page of a four-page document.

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	20 June 2013
Submitter:	GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCE
Primary Contact Person:	Mounir Zaouali, RACRegulatory Affairs LeaderGE Healthcare, (GE Medical Systems, SCS)283 RUE DE LA MINIERE78530 BUC - FRANCEPhone : + 33 1 30 70 45 39Fax : + 33 1 30 70 41 40Mounir.Zaouali@ge.com
Secondary Contact Person:	Steven Kachelmeyer, RACRegulatory Affairs Director - X-rayGE HealthcarePhone: 262-548-2432Fax: 262-997-1080Steven.Kachelmeyer@med.ge.com
Device Trade Name:	eContrast
Common/Usual Name:	Full Field Digital Mammography System
Classification Names:Product Code:	21 CFR 892.1715, Class IIMUE
Predicate Device(s):	Senographe Essential-P990066/S21 with Premium View iK110798
Device Description:	The subject of this submission is a software-only option toSenographe Essential Full Field Digital Mammography (FFDM)system called eContrast.eContrast is an image post-processing algorithm that willintroduce a modification to the previously approved PremiumView (PV) / Premium View i (PVi) (K110798). eContrastprocessing will offer 6 levels of contrast strength for imageviewing, where the desired combination of image sharpness,image smoothness, level of tissue penetration, and level ofcontrast may be selected by the radiologist. The final imageappearance varies according to the selected level.eContrast is a Software only option.
Intended Use:	The Senographe DS and Senographe Essential FFDM systemsgenerate digital mammographic images that can be used forscreening and in the diagnosis of breast cancer. TheSenographe DS and Senographe Essential FFDM systems areintended to be used in the same clinical applications astraditional film-based mammographic systems.Premium View is an image-processing algorithm, which
	increases the visibility of breast structures. The main advantageis to provide a single breast image, where the contrast in thefatty tissues is similar to that obtained by setting WW (windowwidth) and WL (window level) for optimum visualization of fattytissues, and the contrast in the fibro-glandular tissue is similarto that obtained by setting WW and WL for optimal visualizationof fibro-glandular tissues.
	Premium View I (PVi) is an option that can simplify thepresentation of mammographic images, improve workflow, andstreamline the review process of images with very dark orbright areas by presenting the image with the WW and WLoptimized for review with minimal need for the user to makeadjustments for the various tissue areas. This could beespecially useful with patients who have very thin breasts, verydense breasts, or implants that currently require multipleadjustments of WW and WL to review.
	eContrast accommodates different customer displaypreferences in screening and diagnosis, with 5 different levels,while keeping the PVi option for implants. eContrast post-processing is also available for stereo images.
Technology:	The eContrast processing is an image post-processing thatprovides an image display for all breast tissue (fatty andfibroglandular) from the chest to the nipple in a single image.After acquisition, eContrast is applied to the image to create theprocessed image which then replaces the raw image on thescreen of the acquisition workstation.
	The main calculations that are applied to create the processedimage are:
	• Collimator Detection:
	This applies a black mask around the useful image area,covering areas which would otherwise be white. It allows morecomfortable viewing.
	• Pseudo-log Transformation:
	This transformation facilitates the manipulation of brightnessand contrast during the review. After the transformation, theimage dynamic range is reduced to 12 bits, without loss ofclinical information.
	• Thickness Equalization:
	This equalizes the grey level range all over the breast includingthe tissue not under compression and close to the skin line.
	• Dynamic Range Management:This computation locally increases contrast and sharpness forstructure of interest. This effect can be reinforced based on userpreferences.
	• Auto-contrast:
	This improves image quality by optimizing brightness levels(window level) and contrast (window width) in the image.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:
	The eContrast option complies with voluntary standards. Thefollowing quality assurance measures were applied to thedevelopment of the system:
	• Risk Analysis
	• Requirements Reviews
	• Design Reviews
	• Testing on unit level (Module verification)
	• Integration testing (System verification)
	• Performance testing (Verification)
	• Safety testing (Verification)
	• Simulated use testing (Validation)
	Summary of Clinical Tests:
	The subject of this premarket submission, eContrast option, included clinical testing to quantify the clinical acceptance of images that had been retrospectively processed with this image processing algorithm.
	The subject of this premarket submission, eContrast image processing option, included clinical image evaluation to quantify the clinical acceptance of images that had been retrospectively processed with this image processing algorithm.
	The objective of the eContrast clinical evaluation was to determine if the images retrospectively processed with the new processing still provided acceptable clinical image quality.
	The evaluation was based on BIRADS 1 or 2 patients with two fatty breasts, two dense breasts, and 2 images that were in between. This was done to show that the image processing would be acceptable across all types of patients as suggested in the Class II Special Controls Guidance Document for FFDM systems.
Conclusion:	GE Healthcare considers the eContrast option to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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GE Healthcare

510(k) Premarket Notification Submission

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GE Healthcare

510(k) Premarket Notification Submission

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K131885
Page 4 of 4

GE Healthcare

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2013

GE Heathcare % Mr. Mounir Zaouali Regulatory Affairs Leader 283 Rue de la Minière Buc. 78530 FRANCE

Re: K131885

Trade/Device Name: eContrast Regulation Number: 21 CFR 892.1715 Regulation Name: Digital Full Field Mammography Regulatory Class: Class II Product Code: MUE Dated: August 26, 2013 Received: August 28, 2013

Dear Mr. Zaouali:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Zaouali

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21) CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/delault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131885

Device Name: eContrast

Indications for Use:

Prescription Use X =========================================================================================================================================================== (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$m_{h,3}$

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

210(k) K131882

Page 1 of 1

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.