Search Results

Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions 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). Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.

The proposed Affirm® Contrast Biopsy is a licensable software for the Selenia Dimensions and 3Dimensions system platforms (P010025 and P08003, respectively). The proposed software option will be used with the Affirm® Breast Biopsy Guidance System (K103512). The proposed software is a stereotactic lesion localization system option for the Dimensions systems. It allows clinicians to perform biopsy targeting on captured contrast enhanced images. Affirm® Contrast Biopsy uses the same workflow as stereotactic biopsy, substituting standard scout and stereo pair views with contrast enhanced views captured at the associated angles. The proposed device is compatible with the standard vertical biopsy approach as well as the right or left lateral approach.

Affirm® Contrast Biopsy introduces new software and labeling. There are no changes to the Dimensions platform and Affirm® Breast Biopsy Guidance System hardware, platform software architecture, or stereotactic function as a result of the proposed software.

The provided text is a 510(k) Summary for the Hologic Affirm® Contrast Biopsy system. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against specific acceptance criteria for AI/ML device performance.

Therefore, the document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML system's performance. The device described appears to be a hardware/software system for guiding biopsies using contrast-enhanced imaging, not an AI/ML algorithm that requires performance metrics like sensitivity, specificity, or reader studies.

Specifically, the document states: "Non-clinical bench testing demonstrates the Affirm® Contrast Biopsy is substantially equivalent to the predicate and reference device with regards to the indication for use, software, technology, and performance. Design verification testing demonstrates the proposed device complies with design specifications. The software, and performance showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate..." This indicates that bench testing and design verification were conducted to show equivalence, typical for traditional medical devices, not a study focused on AI/ML performance.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document discusses "design specifications" and "equivalent performance" but no specific quantitative acceptance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not mentioned. There is no description of a clinical test set or data origins.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable based on the provided text, as no clinical test set for performance evaluation (e.g., sensitivity/specificity) is described using expert ground truth.
4. Adjudication method: Not applicable.
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: Not applicable. This is not an AI-assisted interpretation device in the traditional sense, but rather a biopsy guidance system. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is described as a system for guidance, not a standalone diagnostic algorithm.
7. The type of ground truth used: Not applicable. No ground truth for performance evaluation (e.g., pathology, expert consensus) is described.
8. The sample size for the training set: Not applicable. This document does not describe an AI/ML model that would have a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary are for a biopsy guidance system that uses contrast-enhanced images, which is cleared based on substantial equivalence to existing predicate devices through bench testing and design verification, rather than a clinical performance study with specific AI/ML acceptance criteria and human-in-the-loop evaluations.

Ask a specific question about this device