The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/ screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

Device Description

eContrast is an image post-processing algorithm applied to the DICOM "for processing" images in order to generate “for presentation" images. It consists in optimizing the local contrasts while reducing the overall dynamic range. This submission is proposing a software modification consisting of a new version of eContrast algorithm for Senographe Pristina platform to allow more flexibility for proposing different levels preserving/enhancing the visibility of the different structures present in the breast image. The first version of the eContrast image processing was previously cleared for Senographe Essential platform in the 510(k)# K131885. Then it was cleared with Senographe Pristina platform in the 510(k) # K162268. This design change is a software and labeling only option, compatible with Senographe Pristina installed base and does not require any hardware modification on the Senographe Pristina platform.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Senographe Pristina with the new version of eContrast, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The provided document describes a change to an existing cleared device (Senographe Pristina with eContrast K162268), specifically a new version of the eContrast post-processing algorithm. The core acceptance criteria revolve around demonstrating that the new version is substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness.

Acceptance Criterion	Reported Device Performance (Summary)
Image Quality Performance: Images acquired with the new version of eContrast are of the same quality as images acquired with the predicate device (Senographe Pristina with eContrast as cleared in K162268) at similar dose levels. (Non-Clinical Data – Image Quality and Dose test)	"demonstrates that images acquired with Senographe Pristina with the new version of eContrast are of same quality as images acquired with Senographe Pristina with eContrast as cleared in K162268 at similar dose levels."
Clinical Image Acceptability: Clinical images generated with the new version of eContrast demonstrate acceptability by radiologists. (Clinical Data – Clinical image review by radiologists, with objective criteria defined)	"demonstrates the clinical image acceptability of images generated with Senographe Pristina with the new version of eContrast."
No Change in Intended Use and Indications for Use: The new algorithm does not alter the fundamental intended use or indications for use from the predicate device.	"The new version of eContrast algorithm for Senographe Pristina does not change the intended use and indications for use to its legally marketed predicate device, the Senographe Pristina with eContrast (K162268). ... Note: The intended use of Senographe Pristina cleared in K162268 is not changed. ... Note: The Indications for use of Senographe Pristina cleared in K162268 are not changed."
Fundamental Principles of Operation Unchanged: The core principles, functionalities, specifications, and technological characteristics of the Senographe Pristina itself remain unchanged.	"The fundamental principles of operation, functionalities, specifications and technological characteristics of Senographe Pristina remain unchanged."
Compliance with Quality Management System and Design Controls: The development and manufacturing adhere to GE Healthcare's quality management system, design controls, and relevant regulations (21CFR 820, ISO 13485). This includes risk analysis, design reviews, software development lifecycle, unit, integration, performance, safety, and simulated use testing.	"Senographe Pristina with the new version of eContrast has successfully completed required design control testing per GE Healthcare's quality management system. No unexpected test results were obtained. The design change was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system: - Risk Analysis - Design Reviews - Software Development Lifecycle - Testing on unit level (Module verification) - Integration testing (System verification) - Performance testing (Verification) - Safety testing (Verification) - Simulated use testing (Validation)"

2. Sample Size and Data Provenance for Test Set (Clinical Data)

Sample Size: Not explicitly stated for the clinical image review. The document mentions "clinical image review by radiologists" but does not specify the number of images or cases reviewed.
Data Provenance: Not explicitly stated. It's likely retrospective as it involves reviewing existing images, but this is not confirmed. The country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth (Clinical Data)

Number of Experts: "radiologists" (plural), but the exact number is not specified.
Qualifications: "radiologists." Specific years of experience or sub-specialty are not provided.

4. Adjudication Method for Test Set (Clinical Data)

Adjudication Method: Not explicitly stated. The document mentions "clinical image review by radiologists, with objective criteria defined," but does not detail how disagreements among radiologists, if any, were resolved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC Study was done. The study's purpose was to demonstrate substantial equivalence of a new version of an image processing algorithm, not to show improvement of human readers with AI assistance. It aimed to show that the new algorithm's output was "acceptable" and "same quality" as the previous version.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was implicitly done through the "Non-Clinical Data – Image Quality and Dose test." This test would assess the direct output of the algorithm (image quality) without human intervention, comparing it to the previous version's output. The document states this test "demonstrates that images acquired with Senographe Pristina with the new version of eContrast are of same quality as images acquired with Senographe Pristina with eContrast as cleared in K162268 at similar dose levels."

7. Type of Ground Truth Used

Non-Clinical Data (Image Quality): The ground truth for image quality comparison would likely be based on established image quality metrics, possibly evaluated against images from the predicate device as a reference standard. These are objective measures rather than expert consensus on disease.
Clinical Data (Clinical Image Acceptability): The ground truth for clinical image acceptability was established via "objective criteria defined" by radiologists. This suggests a form of expert consensus or adherence to predefined quality standards for clinical interpretation, rather than pathology or outcomes data related to disease detection.

8. Sample Size for the Training Set

Not applicable / Not disclosed. The document describes a modification to an existing algorithm (eContrast) rather than the development of a wholly new AI model that typically requires a separate training set. The new version of eContrast is an "extension of the current algorithm." If any internal parameter tuning or retraining occurred, the details of a training set are not provided. It's more of an algorithm update than a de novo AI model.

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

Not applicable / Not disclosed. As noted above, this appears to be an algorithm update rather than a new AI model requiring a separate training set with specific ground truth for learning.

Summary

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August 6, 2021

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GE Healthcare % Barthélémy Arman Regulatory Affairs Leader 283 rue de la Minière BUC, 78530 FRANCE

Re: K211725

Trade/Device Name: Senographe Pristina Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: June 4, 2021 Received: June 4, 2021

Dear Barthélémy Arman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211725

Device Name Senographe Pristina

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary — K211725

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

Date:	August 6th, 2021
Submitter:	GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCE
Primary Contact Person:	Barthélémy ArmanRegulatory Affairs Leader283 rue de la Minière78530 Buc - FRANCEPhone : +33 1 30 70 40 40Email : Barthelemy.ARMAN1@ge.com
Secondary Contact Person:	Gregory Pessato,Regulatory Affairs Senior Manager,GE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCEPhone : + 33 1 30 70 93 16Email : gregorypessato@ge.com
Device Trade Name:	Senographe Pristina [Design change: New version of eContrast]
Common/Usual Name:	Full Field Digital,System,X-Ray,Mammographic
Classification Names:	21 CFR 892.1715, Class II
Product Code:	MUE
Predicate / Reference Device(s):	Senographe Pristina (K162268) – predicate
Device Description:	eContrast is an image post-processing algorithm applied to the DICOM"for processing" images in order to generate “for presentation" images.It consists in optimizing the local contrasts while reducing the overalldynamic range.This submission is proposing a software modification consisting of anew version of eContrast algorithm for Senographe Pristina platformto allow more flexibility for proposing different levels.

	preserving/enhancing the visibility of the different structures present inthe breast image.
	The first version of the eContrast image processing was previouslycleared for Senographe Essential platform in the 510(k)# K131885. Thenit was cleared with Senographe Pristina platform in the 510(k) #K162268.
	This design change is a software and labeling only option, compatiblewith Senographe Pristina installed base and does not require anyhardware modification on the Senographe Pristina platform.
Intended Use:	The Senographe Pristina system is intended for screening anddiagnostic mammography.Note: The intended use of Senographe Pristina cleared in K162268 is notchanged.
Indications for Use	The Senographe Pristina system is intended to be used in the sameclinical applications as traditional mammographic film/screen systems.It generates digital mammographic images which can be used forscreening and diagnosis of breast cancer.Note: The Indications for use of Senographe Pristina cleared in K162268are not changed.
Technology:	The modification of the eContrast post-processing algorithm iscompletely independent from all other parts of the digitalmammographic equipment Senographe Pristina. Only the software isaffected by this change.This new version of eContrast offers as before, 6 settings (eContrast 1to eContrast 6) to accommodate different user preferences. eContrast 1and 6 remain unchanged, with a 2-band decomposition. However, forsettings 2, 3, 4 and 5, the new version of eContrast is an extension ofthe current algorithm with a third band decomposition to allow moreflexibility for proposing different levels preserving/enhancing thevisibility of the different structures present in the breast image.
Substantial Equivalence /Predicate and ReferenceDevices	The new version of eContrast algorithm for Senographe Pristina doesnot change the intended use and indications for use to its legallymarketed predicate device, the Senographe Pristina with eContrast(K162268).The fundamental principles of operation, functionalities, specificationsand technological characteristics of Senographe Pristina remainunchanged.The eContrast post-processing algorithm is modified to allow moreflexibility for proposing different levels preserving/enhancing thevisibility of the different structures present in the breast image.It was demonstrated in Image Quality Performance Testing that theimage quality of Senographe Pristina with this new version of
	eContrast performs similarly as its legally marketed predicate device,the Senographe Pristina with eContrast (K162268).
Determination of SubstantialEquivalence:	Senographe Pristina with the new version of eContrast has successfullycompleted required design control testing per GE Healthcare's qualitymanagement system. No unexpected test results were obtained. Thedesign change was designed and will be manufactured under theQuality System Regulations of 21CFR 820 and ISO 13485. The followingquality assurance measures were applied to the development of thesystem:- Risk Analysis
	- Design Reviews
	- Software Development Lifecycle
	- Testing on unit level (Module verification)
	- Integration testing (System verification)
	- Performance testing (Verification)
	- Safety testing (Verification)
	- Simulated use testing (Validation)
	The safety and performance of Senographe Pristina with the newversion of eContrast was demonstrated through full verification testingand additional engineering bench performance testing such as:- Non-Clinical Data – Image Quality and Dose test thatdemonstrates that images acquired with SenographePristina with the new version of eContrast are of samequality as images acquired with Senographe Pristina witheContrast as cleared in K162268 at similar dose levels.- Clinical Data – Clinical image review by radiologists, withobjective criteria defined that demonstrates the clinicalimage acceptability of images generated with SenographePristina with the new version of eContrast.These tests demonstrated the substantial equivalence with thepredicate device and concluded that Senographe Pristina with the newversion of eContrast do not raise any questions of safety andeffectiveness.
Conclusion:	Based on: conformance to standards; development under GEHealthcare's quality management system and design controls;successful verification/validation testing and additional benchperformance testing and clinical testing, GE Healthcare believes thatSenographe Pristina with the new version of eContrast is substantiallyequivalent to its predicate device Senographe Pristina with eContrast ascleared in K162268. Therefore, GE concludes that Senographe Pristinaremains as safe and effective for its intended use as its predicatedevice.

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GE Healthcare

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510(k) Premarket Notification Submission

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510(k) Premarket Notification Submission

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.