(175 days)
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).
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.
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.
§ 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.