Pristina Serena by GE Healthcare

The Pristina Serena option provides the three-dimensional locations, using information obtained from stereotactic pairs of two-dimensional X-ray images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (FNA).

Device Description

Pristina Serena is a hardware and software add-on to the Senographe Pristina mammography platform (cleared in K162268).
Pristina Serena uses the Stereotaxy principle to determine the three-dimensional (3D) location (X, Y and Z coordinates) of a region of interest in the breast (such as a suspicious lesion).
The stereotaxy biopsy process uses a stereo pair of +/-15° angulated 2D low-dose X-ray images of the compressed breast. The user identifies the point of interest in each image of the stereo pair, Pristina Serena computes the three dimensions coordinates (X,Y,Z) of the user-specified location in the stereo pair.
Pristina Serena uses the target lesion 3D coordinates and information on the geometry of the biopsy device to compute the position of a biopsy device holder that will allow intervention in the breast at the targeted position (biopsy of sample tissue or placement of a hookwire for guidance of surgical interventions).
The Pristina Serena add-on includes the following items:
Hardware: a Biopsy Positioner (BP) the main hardware component of the Pristina Serena option. It can be mounted on the Senographe Pristina in lieu of the Imaging Bucky. The purpose of the BP is to allows breast positioning and mechanical guidance to the target lesion for Biopsy medical application; dedicated breast compression paddles for Biopsy application; mechanical adaptors: pieces of hardware to allow mounting of several kind of biopsy devices on the Biopsy positioner arm.
Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena option. Labeling for the Biopsy Medical application.
Pristina Serena option is compatible with previously installed Senographe Pristina systems. Pristina Serena does not require any hardware modification on the Senographe Pristina platform.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them, specifically for the GE Healthcare Pristina Serena.

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a full clinical trial report or a detailed performance validation study. Therefore, some information, particularly regarding specifics of human reader studies (MRMC), detailed ground truth methodologies for large datasets, and training set information, may not be explicitly present or fully elaborated upon as one might find in a peer-reviewed publication or a more comprehensive FDA submission. The focus here is on bench performance testing for accuracy and engineering validation for safety and proper function.

Acceptance Criteria and Device Performance for Pristina Serena (K173576)

The primary acceptance criteria mentioned for the Pristina Serena are related to its biopsy accuracy and image quality/dose performance, demonstrating equivalence to its predicate device (Senographe Stereo) and reference predicate (Senographe Pristina).

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Specific Acceptance Criteria (as implied from the text)	Reported Device Performance (Summary from text)
Biopsy Accuracy	Geometrical accuracy between the target lesion identified on X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch).	"The targeting accuracy of Pristina Serena is equivalent to that of Senographe Stereo." "Biopsy accuracy testing: verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." (Explicit numerical performance metric not provided in this summary, but equivalence to predicate is claimed.)
Image Quality & Dose	Performance in Biopsy mode with Pristina Serena is substantially equivalent to that of Senographe Pristina screening/diagnostic imaging system.	"Image quality and dose performance testing to confirm that performance in Biopsy mode with Pristina Serena is substantially equivalent to that of Senographe Pristina screening/diagnostic imaging system." "Pristina Serena uses the image chain of the Senographe Pristina mammography platform, therefore delivering images of quality equivalent to that of standard screening/diagnostic images."
Safety & Functionality	Device performs according to specifications and functions as intended, meeting quality system regulations (21 CFR 820, ISO 13485).	"The device has successfully completed required design control testing per GE Healthcare's quality management system. No unexpected test results were obtained." "Testing demonstrated that Pristina Serena performs according to specifications and functions as intended."

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

The text does not specify numerical sample sizes for the "biopsy accuracy testing" or "image quality and dose performance testing."

Regarding data provenance:

The tests described ("engineering bench performance testing") are laboratory-based and simulation-based.
The device is manufactured by GE Healthcare in France (283 RUE DE LA MINIERE, 78530 BUC - FRANCE).
The nature of the testing implies these are prospective bench tests performed during device development and validation.
The data used for these engineering tests would typically be generated in a controlled lab environment rather than being retrospective patient data from a specific country, as these are tests of the device's technical specifications.

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

For the engineering bench tests described (biopsy accuracy, image quality/dose), the concept of "experts establishing ground truth for a test set" in the context of human interpretation of medical images (like for an AI algorithm's diagnostic performance) is not directly applicable.

Ground truth for biopsy accuracy: This would be established by precise metrology and physical measurements of the needle tip's position relative to a target in a phantom using the device. This is a technical measurement, not an expert interpretation.
Ground truth for image quality/dose: This would be established by physical measurements (e.g., dose meters) and standardized image quality metrics (e.g., contrast, spatial resolution) using phantoms, not by human experts.

Therefore, the text does not mention human experts for establishing ground truth for these specific performance tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Given that the performance evaluation relies on "engineering bench performance testing" and technical measurements/verification, adjudication methods as typically used in human reader studies (like 2+1 or 3+1 consensus for ambiguous cases) are not applicable or mentioned in this context. The determination of accuracy and image quality is based on objective, quantifiable metrics following established engineering protocols.

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

No MRMC comparative effectiveness study is mentioned in this 510(k) summary. The Pristina Serena device is a stereotactic biopsy guidance system, not an AI-assisted diagnostic tool for image interpretation. Its function is to guide physical interventions, not to interpret images for diagnosis alongside human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This device is not an AI algorithm for image interpretation. It's a hardware and software add-on that uses stereotaxy principles to calculate 3D coordinates based on user-identified points in 2D images.

The "standalone" performance here refers to the system's ability to accurately calculate the 3D coordinates and guide the biopsy device. This was addressed by the "Biopsy accuracy testing."
The user is "human-in-the-loop" by identifying the initial point of interest in the images, but the calculation itself is algorithmic/systemic. The tests confirm the accuracy of the system's output (3D coordinates and guidance).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "Biopsy accuracy testing":

The ground truth is established by physical measurement of the actual position of the biopsy needle tip (or needle notch) relative to a known target in a phantom. This is a highly precise engineering measurement.
It is not based on expert consensus, pathology, or outcomes data, as those are typically used for diagnostic or prognostic AI systems evaluated on patient data.

For "Image quality and dose performance testing":

The ground truth is established by physical measurements using phantoms and adherence to established image quality metrics.

8. The sample size for the training set

The text does not mention a training set sample size. This is expected because the Pristina Serena is a stereotactic guidance system, not a machine learning or deep learning AI model that requires a vast training dataset of medical images. Its core function is based on principles of geometry and X-ray physics to calculate 3D coordinates from 2D images.

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

As no training set (in the context of machine learning) is mentioned or implied for this device, the question of how its ground truth was established is not applicable. The device's operation relies on established physical and mathematical principles, which do not typically involve a "training" phase with ground-truth labels in the way AI/ML algorithms do. The development involved traditional software development lifecycle testing, verification, and validation against engineering specifications.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 14, 2018

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

Re: K173576

Trade/Device Name: Pristina Serena Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: April 11, 2018 Received: April 13, 2018

Dear Gregory 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.

{1}------------------------------------------------

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 CDRHs Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173576

Device Name Pristina Serena

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. The circle is surrounded by a thin white border, and there are four small white teardrop shapes evenly spaced around the perimeter of the circle.

510(k) Summary

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

Date:	March 28, 2018
Submitter:	GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCE
Primary Contact Person:	Gregory Pessato,Regulatory Affairs Program Manager,GE Medical Systems SCS,283 RUE DE LA MINIERE78530 BUC - FRANCEPhone : + 33 1 30 70 93 16Email : gregorypessato@ge.com
Secondary Contact Person:	Diane UriellSr. Director of Regulatory Affairs, XR and Women's Health,GE Healthcare,Atlanta, Georgia - USAPhone +1 262 290 8212Email: Diane.Uriell@ge.com
Device Trade Name:	Pristina Serena
Common/Usual Name:	Stereotaxy biopsy guidance application for a Full Field DigitalMammography System
Classification Names:	21 CFR 892.1715, Full-field digital mammography system, Class II
Product Code:	MUE
Predicate Device(s):	Senographe Stereo (K040125)
Reference Predicate(s)	Senographe Pristina (K162268)
Device Description:	Pristina Serena is a hardware and software add-on to the SenographePristina mammography platform (cleared in K162268).
	Pristina Serena uses the Stereotaxy principle to determine the three-dimensional (3D) location (X, Y and Z coordinates) of a region ofinterest in the breast (such as a suspicious lesion).The stereotaxy biopsy process uses a stereo pair of +/-15° angulated2D low-dose X-ray images of the compressed breast. The useridentifies the point of interest in each image of the stereo pair,Pristina Serena computes the three dimensions coordinates (X,Y,Z) ofthe user-specified location in the stereo pair.Pristina Serena uses the target lesion 3D coordinates and informationon the geometry of the biopsy device to compute the position of abiopsy device holder that will allow intervention in the breast at thetargeted position (biopsy of sample tissue or placement of a hookwirefor guidance of surgical interventions).The Pristina Serena add-on includes the following items:Hardware: a Biopsy Positioner (BP) the main hardwarecomponent of the Pristina Serena option. It can bemounted on the Senographe Pristina in lieu of theImaging Bucky. The purpose of the BP is to allowsbreast positioning and mechanical guidance to thetarget lesion for Biopsy medical application; dedicated breast compression paddles for Biopsyapplication; mechanical adaptors: pieces of hardware to allowmounting of several kind of biopsy devices on theBiopsy positioner arm. Software: A new software version for the Senographe Pristinaplatform which includes software to manage the PristinaSerena option. Labeling for the Biopsy Medical application.
	Pristina Serena option is compatible with previously installedSenographe Pristina systems. Pristina Serena does not require anyhardware modification on the Senographe Pristina platform.
Intended Use:	Pristina Serena is an optional accessory of Senographe Pristinaintended to provide accurate location of lesions in the breast in threedimensions.
Indications for Use	The Pristina Serena option provides the three-dimensional location oftarget lesions, using information obtained from stereotactic pairs oftwo-dimensional X-ray images. This information provides guidance fora variety of minimally invasive or interventional procedures in the
	breast such as: vacuum assisted biopsy, core biopsy, pre-surgicallocalization (e.g. hookwire), and fine needle aspirations (FNA).
Device Comparison:	Pristina Serena uses the same fundamental technology as SenographeStereo in terms of lesion targeting technique (2D stereotactic biopsy),stereotactic angle, needle approach (vertical or lateral), field of viewand attainable breast volume. Like its predicate, Pristina Serenasupports various breast biopsy and intervention devices. Thetargeting accuracy of Pristina Serena is equivalent to that ofSenographe Stereo.The main differences between Pristina Serena and Senographe Stereoinclude:- Ability to target a lesion above the compression paddle invertical approach;- Ability to switch needle approach without patientrepositioning;- A tilted needle axis to accommodate future 3D biopsyapplication.Pristina Serena uses the image chain of the Senographe Pristinamammography platform, therefore delivering images of qualityequivalent to that of standard screening/diagnostic images.
Performance Testing	The safety and performance of the Pristina Serena option wasdemonstrated through engineering bench performance testing suchas:Biopsy accuracy testing: verification of the geometricalaccuracy between the target lesion identified on the X-rayStereo pair images and the actual position of the biopsyneedle tip (or needle notch). Image quality and dose performance testing to confirm thatperformance in Biopsy mode with Pristina Serena issubstantially equivalent to that of Senographe Pristinascreening/diagnostic imaging system. In addition, the device has successfully completed required designcontrol testing per GE Healthcare's quality management system. Nounexpected test results were obtained. The Pristina Serena optionwas designed and will be manufactured under the Quality SystemRegulations of 21CFR 820 and ISO 13485. The following qualityassurance 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) These tests were performed to provide the requisite data to substantiate performance, claims, and ultimately substantial equivalence. Testing demonstrated that Pristina Serena performs according to specifications and functions as intended.
Substantial EquivalenceDetermination:	Pristina Serena has the same indications for use as its predicate Device. It uses the same fundamental technology as Senographe Stereo. Differences between Pristina Serena and Senographe Stereo do not raise new questions of safety and effectiveness. The impact of differences between the predicate and new device has been assessed using established methods. Testing including conformance to standards; successful verification/validation; and additional bench performance testing, establish that Pristina Serena is substantially equivalent to its predicate Senographe Stereo (K040125) for biopsy functions and reference predicate Senographe Pristina (K162268) for imaging performance.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are also three droplet-like shapes surrounding the circle, giving the impression of motion or energy.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white swirls around the outside of the circle. The logo is simple and recognizable.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. There are white swirls around the letters, and a white border around the blue circle. The logo is simple and recognizable, and it is associated with a well-known company.

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.