(38 days)
The Affirm breast biopsy guidance system is an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).
The Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D Full Field Digital Mammography System (FFDM), is a stereotactic lesion localization system that has the application of localizing, and then giving a physician the capability of performing fine needle aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
Stereotactic images on the host mammography system are acquired at +/-15°. The stereo images are calculated with Cartesian coordinates to target lesions. Stereo images are displayed on the mammography system display for the targeting procedure. Images are then sent to PACS for archiving via DICOM protocol.
Safety Features include:
Automatic detection of mounting, latching, and connection of biopsy module
C-arm motion disabled if biopsy module is not locked in place
Automatic compression release disabled when biopsy module installed
Motorized movement of biopsy device only under user control
Audible alert if biopsy device motion could result in mechanical interference
The provided document, a 510(k) summary for the Hologic Affirm Breast Biopsy Guidance System, does not contain the detailed information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, its provenance, or how ground truth was established for it.
- Details on the number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on any multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Information on a standalone performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how ground truth for the training set was established.
Based on the provided text, the available information is as follows:
1. A table of acceptance criteria and the reported device performance:
The document states that "The Hologic Affirm Breast Biopsy Guidance System was successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards" and "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820."
It does not provide specific acceptance criteria or quantitative performance metrics in a table format for a clinical or performance study of the guidance system's accuracy in localizing lesions, which would typically be relevant for a device like this. The "performance" mentioned is with respect to safety and regulatory compliance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 document describes the device as a "stereotactic lesion localization system" and a "guidance system for interventional purposes." It does not mention any MRMC study comparing human reader performance with or without AI assistance, nor does it provide an effect size.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document does not explicitly describe a standalone performance study in the context of lesion localization accuracy. The "Summary of Testing" focuses on compliance with electrical safety standards and design control verification/validation, not clinical performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary of available information regarding the study:
- Study Purpose: To demonstrate substantial equivalence to the predicate device (Hologic Digital StereoLoc II) and perform safety and design control verification/validation.
- Safety Testing: Successfully tested by UL to IEC 60601-1 Medical Electrical Equipment Standards for electrical and mechanical safety.
- Regulatory Compliance: Conforms with ACR/NEMA Digital Imaging Communications in Medicine version 3.0 for image capture, saving, and transmission. Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820.
- Conclusion: The device's design, operation, construction, and materials are similar to existing marketed devices with no additional risks or hazards, supporting its substantial equivalence determination.
The document primarily focuses on regulatory compliance, safety, and substantial equivalence to a predicate device, rather than detailed clinical performance studies with specific acceptance criteria and outcome metrics that would typically be associated with AI or advanced diagnostic devices.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.