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510(k) Data Aggregation
(122 days)
Pristina Serena (K173576)
Sample Imaging for Senographe Pristina™ with Pristina Serena™ biopsy option is intended to provide digital X-ray images of the biopsy excised breast tissues while the patient is still under compression, to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Sample Imaging for Senographe Pristina is an additional option that builds upon the Pristina Serena Stereotaxy biopsy device cleared on May 14, 2018 (K173576). The Sample Imaging option enables the imaging of breast tissue samples collected during biopsy medical application. In other words, the Sample Imaging option provides the capability to image, within the same examination, and while the patient is still under compression, the breast tissue samples collected during biopsy procedures performed with any biopsy medical application available on the system. The acquisition of such images is done with dose to the patient limited to scatter radiation from the samples.
The provided text describes a 510(k) submission for "Sample Imaging for Senographe Pristina" by GE Healthcare. The purpose of this device is to provide X-ray images of excised breast tissues during biopsy procedures for rapid verification.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the safety and performance claims made and the comparative testing against a predicate device and a reference device. The primary performance claim is regarding image quality and dose.
| Acceptance Criteria / Claim | Reported Device Performance (as tested) |
|---|---|
| Image quality equivalent to or better than Pristina Serena (reference device). | Image Quality test: Images acquired with Sample Imaging are of the same quality as images acquired with Pristina Serena or Pristina Serena 3D. The image quality assessment conducted shows that Sample Imaging views have better performance than 2D scout biopsy and DBT biopsy views. This assessment was performed with the ACR mini stereotactic breast biopsy accreditation phantom. The test results demonstrate that image quality of Sample Imaging mode is sufficient to verify the presence of targeted tissues in the samples and to achieve its indications for use. |
| Image quality sufficient to verify the presence of targeted tissues in samples. | As above: The test results demonstrate that image quality of Sample Imaging mode is sufficient to verify the presence of targeted tissues in the samples and to achieve its indications for use. |
| Continuous zoom feature allows the user to reach a zoom identical or better than a magnification glass. | The device, similar to the predicate, "Both features provide the capability of continuous zoom which allows the user to reach a zoom identical or better that what the magnification glass offers." (This is a statement of shared functionality with the predicate, implying this is met). |
| MTF (Modulation Transfer Function) performance. | MTF measurement: MTF was measured using the same acquisition techniques and compared between biopsy area and sample imaging area. Images were processed with "FineView" adapted to biopsy and simple imaging parameters respectively. With "FineView" applied, the MTF of the Sample images is higher than the MTF for the Biopsy 2D images at any frequency. |
| Patient Radiation Dose. | Patient Radiation Dose Testing: Since the breast of the patient is not in the primary X-ray beam, no direct radiation dose is delivered to the patient. However, scatter radiation from the samples and detector were measured. The Air Kerma at the point of skin entry in the patient's breast closest to the biopsy samples being imaged was measured at 1.99% of the Entrance Skin Air Kerma (ESAK) from a biopsy AOP scout view for an average breast. |
| Conformance to specifications and intended function. | The testing demonstrated that Sample Imaging for Senographe Pristina performs according to specifications and functions as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set used in the performance evaluation.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective patient data. The tests appear to be pre-clinical bench testing ("Image Quality test," "Patient Radiation Dose Testing," "MTF was measured") rather than studies on a patient cohort. The "ACR mini stereotactic breast biopsy accreditation phantom" was used, indicating phantom-based testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention any human experts being used to establish a ground truth for the test set. The evaluation relies on objective technical measurements (image quality, MTF, dose) using a phantom, rather than human expert interpretation of images.
4. Adjudication Method for the Test Set
Since no human experts were involved in evaluating images for ground truth, there was no adjudication method described. The tests were objective, technical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done as described in the provided text. The evaluation focuses on technical performance metrics (image quality, MTF, dose) of the device itself, rather than assessing human reader performance with or without the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is an "imaging option" that provides digital X-ray images. The "performance" described is about the quality of these images and the dose produced. This is inherently a "standalone" or "algorithm only" performance since it refers to the image acquisition and processing capabilities of the system (e.g., "FineView" processing, MTF measurements, image quality on a phantom). It's not an AI algorithm but a hardware/software imaging feature.
7. The Type of Ground Truth Used
The ground truth for the performance testing was established by technical metrics and a standardized phantom.
- ACR mini stereotactic breast biopsy accreditation phantom: Used for Image Quality assessment.
- MTF measurements: Optical/technical property of image sharpness.
- Air Kerma measurements: Objective radiation dose measurement.
This is not expert consensus, pathology, or outcomes data, but rather a phantom-based, objective technical evaluation.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI models. This device is an imaging system component, not an AI algorithm that requires a training set of data. The development process mentions "development under GE Healthcare's quality management system and design controls" and "full verification testing and additional engineering bench performance testing."
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an AI/ML component, this question is not applicable based on the provided information. The device functions as an imaging system, and its performance verification appears to be based on engineering and quality control procedures, rather than a data-driven training/validation paradigm.
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