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The Sertera Biopsy Device is intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast. When used for breast biopsy, the product is for diagnosis only. It is not intended for use in bone.

The Hologic Sertera Biopsy Device is a spring-loaded core biopsy device to be used primarily in ultrasound-guided breast biopsies. The Sertera Biopsy Device is a disposable, hand-held springloaded core biopsy device that is fully operable with one hand. The Sertera Biopsy Device consists of a hand piece, which advances an inner needle with a side aperture to penetrate into the tissue, and a sharpened outer cutting cannula that extends over the aperture with sufficient force to slice the tissue. The Sertera Biopsy Device is available with 12 and 14 gauge needles.

This document describes the FDA 510(k) clearance for the Sertera Biopsy Device. It does not contain the detailed information necessary to answer all the questions about specific acceptance criteria and study methodologies, particularly concerning AI/algorithm performance.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document states: "Bench testing of the Sertera Biopsy Device demonstrated equivalent performance to the predicate devices, and met all acceptance criteria." and "The Sertera Biopsy Device met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, the specific acceptance criteria (e.g., maximum deflection, tissue sample size, cutting force, etc.) and the quantitative reported performance metrics are not provided in this summary. The table above only compares Intended Use, Method of Use, Mechanism of Action, and Mode of Operation, not performance metrics.

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

The document mentions "Bench testing," which implies laboratory-based testing of the device itself. It does not provide details on the sample size (e.g., number of biopsies performed, number of devices tested) or data provenance for any clinical test set.

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

This information is not provided in the document as it focuses on the equivalence of a physical biopsy device, not an AI / algorithm that requires ground truth established by experts.

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

This information is not provided. This is not relevant for a physical biopsy device's performance testing described here.

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

There is no indication that an MRMC study was done, nor is there any mention of AI assistance. The Sertera Biopsy Device is a physical medical instrument for obtaining tissue samples.

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

There is no indication of any algorithm or AI component in the Sertera Biopsy Device, so a standalone algorithm performance study would not be applicable.

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

The concept of "ground truth" as it applies to AI/algorithm performance is not directly applicable to this document. For a biopsy device, performance validation would typically involve assessing the quality and quantity of tissue samples obtained, possibly against a histological standard or comparison to predicate device sample quality. However, the exact methods are not detailed.

8. The sample size for the training set

There is no mention of a training set as the device is a physical instrument, not an AI/algorithm.

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

Not applicable as there is no mention of a training set or AI/algorithm.

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