Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional mammographic screenfilm systems.

Device Description

Senographe Pristina is a new Full Field Digital Mammography (FFDM) system. The system consists of an X-ray image acquisition system dedicated to breast imaging and of a control station for image acquisition, processing and display. The image acquisition system includes a Cesium lodine digital detector, x-ray tube, integrated high voltage generator, compression paddles. The control station provides a touch-screen user interface to control image acquisition, image processing, and image transfer.

AI/ML Overview

The provided text describes GE Healthcare's Senographe Pristina, a full-field digital mammography system, and its FDA 510(k) clearance (K162268). The document summarizes the device, its indications for use, comparison to a predicate device (Senographe Essential), and the studies conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions a "Clinical image evaluation was performed showing that image quality of Senographe Pristina in a clinical setting is good as assessed by expert radiologists." However, specific quantitative acceptance criteria or numerical performance metrics for this clinical image evaluation are not explicitly stated in the provided text. The statement "showing appropriate performance" in the context of "Complete Image Quality Bench Performance testing" also lacks specific metrics.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the provided text in a quantitative sense. The acceptance criterion appears to be a qualitative assessment by expert radiologists that the image quality is "good."

2. Sample size used for the test set and the data provenance:

The provided text does not explicitly state the sample size used for the clinical image evaluation (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "a clinical setting."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The text states that image quality was "assessed by expert radiologists." However, the number of experts and their specific qualifications (e.g., years of experience) are not specified in the provided document.

4. Adjudication method for the test set:

The adjudication method used for the clinical image evaluation is not specified in the provided text. It only mentions assessment by "expert radiologists."

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The provided document describes the Senographe Pristina as a full-field digital mammography system for image acquisition, not an AI-driven image analysis or CAD device. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" would not be applicable for this device as described. The focus is on demonstrating equivalent image quality to a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Similar to point 5, the Senographe Pristina is an image acquisition system, not an AI algorithm for diagnosis. Therefore, a standalone performance study of an algorithm without human-in-the-loop performance is not applicable in this context. The "Clinical image evaluation" mentioned appears to involve human radiologists assessing the quality of images produced by the device.

7. The type of ground truth used:

For the clinical image evaluation, the "ground truth" for image quality appears to be the qualitative assessment of "good" image quality by expert radiologists. This is based on visual assessment of factors like clarity, contrast, and resolution relevant for screening and diagnosis, implying a form of expert consensus on image interpretability, rather than a definitive "truth" like pathology or outcomes data.

8. The sample size for the training set:

As the Senographe Pristina is a hardware device (mammography system) and not an AI algorithm directly, the concept of a "training set" in the context of machine learning is not directly applicable to the device itself.
The "Complete Image Quality Bench Performance testing" and "Clinical image evaluation" are more akin to validation steps for the device's imaging capabilities, rather than training data for an AI model.

9. How the ground truth for the training set was established:

Since a traditional "training set" for an AI algorithm is not explicitly discussed for this device, the question of how its ground truth was established is not applicable in the context of the provided document. The development and testing of the device focus on hardware performance and image quality validation against established medical standards and comparison to a predicate device.

Summary

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

November 3, 2016

GE Healthcare % Mr. Gregory Pessato Regulatory Affairs Program Manager 283 rue de la Miniere Buc, 78530 FRANCE

Re: K162268

Trade/Device Name: Senographe Pristina Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: August 16, 2016 Received: August 17, 2016

Dear Mr. Pessato:

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 (21 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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 Industry and Consumer Education 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,

Michael D.'Hara

For

Robert Ochs, Ph.D. 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)

K162268

Device Name Senographe Pristina

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

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

Date:	August 5, 2016
Submitter:	GE Medical Systems SCS
Primary Contact Person:	Gregory PessatoRegulatory Affairs Program ManagerGE Healthcare283 RUE DE LA MINIERE78530 BUC - FRANCEPhone : + 33 1 30 70 93 16Email : GregoryPessato@ge.com
Secondary ContactPerson:	Diane UriellDirector of Regulatory Affairs, XR and Women's HealthGE HealthcareAtlanta GAPhone +1 262 290 8212Email:Diane.Uriell@ge.com .
Device Trade Name:	Senographe Pristina
Common/Usual Name:	Full-field digital mammography system
Classification Names:	Full-field digital mammography system
	Class II CFR 892.1715
Product Code:	MUE
Predicate Device(s):	Senographe Essential (P990066/S021)
Device Description:	Senographe Pristina is a new Full Field Digital Mammography (FFDM)system. The system consists of an X-ray image acquisition systemdedicated to breast imaging and of a control station for image acquisition,processing and display. The image acquisition system includes a Cesiumlodine digital detector, x-ray tube, integrated high voltage generator,compression paddles. The control station provides a touch-screen userinterface to control image acquisition, image processing, and imagetransfer.
Indications for Use:	Senographe Pristina generates digital mammographic images that can beused for screening and in the diagnosis of breast cancer. SenographePristina is intended to be used in the same clinical applications astraditional film-based mammographic systems.
Comparison OfTechnologicalCharacteristics With ThePredicate Device:	Senographe Pristina uses the same fundamental technology asSenographe Essential in terms of image acquisition (X-ray tube, detector,image processing). Senographe Pristina includes a dual track anode withsilver filter, a Cesium lodine detector
	Senographe Pristina was redesigned using actualized components andimproved ergonomics. In particular Senographe Pristina was designedwith:
	Improved patient ergonomics (rounded shapes, soft armrests, thinbreast support) for improved patient comfort;
	Improved technologist ergonomics (large workspace, sliding implant /small breast paddle) for better access to patient and eased patientpositioning;
	A new gantry motorization with independent compression and X-raytube head angulation for upgradability to 3D;
	Integrated X-ray generator for reduced footprint.
Determination ofSubstantial Equivalence:	Senographe Pristina has the same indications for use as its predicatedevice. It uses the same fundamental technology as Senographe Essential.Differences between Senographe Pristina do not raise new questions ofsafety and effectiveness.
	The impact of differences between the predicate and new device has beenassessed using applicable FDA Guidance and Standards.
	In particular the following testing was performed:
	Complete Image Quality Bench Performance testing was completedshowing appropriate performance.
	A Clinical image evaluation was performed showing that image qualityof Senographe Pristina in a clinical setting is good as assessed by expertradiologists.
	Compliance was demonstrated against applicable safety andperformance standards. Successful System and Software verification and validation.
Conclusion:	Senographe Pristina is substantially equivalent to its predicate deviceSenographe Essential.

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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.