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The Auto Suture* MIBB** System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes.

The MIBB** system is comprised of a biopsy needle probe, a probe driver and a control module vacuum source. The MIBB** system is a minimally invasive biopsy device designed to pierce, cut and collect tissue during a biopsy procedure.

This K973496 premarket notification describes the Auto Suture Minimally Invasive Breast Biopsy (MIBB) System. However, this document is a 510(k) summary and does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a study proving device performance. The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed clinical study with performance metrics.

Based only on the provided text, here's what can be extracted and what cannot:

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

The provided document does not contain acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. It focuses on device description, intended use, and materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary. A 510(k) summary typically doesn't detail the test set for performance studies in this manner; such information would be in the full 510(k) submission.

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 present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

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

This document describes a biopsy device (a physical instrument), not an AI-powered diagnostic system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

As this is a physical biopsy device and not a diagnostic algorithm, a standalone algorithm performance study is not applicable and not mentioned.

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

This information is not present. For a biopsy device, the ground truth for diagnostic accuracy would typically be pathology results from the obtained tissue samples. However, no data related to this is provided in the summary.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. As it's a physical device and not an algorithm, a "training set" in the context of machine learning isn't directly relevant.

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

This information is not present.

Summary of what can be extracted, based on the provided text:

This document is a 510(k) summary (K973496) from December 1, 1997, for the Auto Suture Minimally Invasive Breast Biopsy (MIBB) System.

Intended Use: The Auto Suture MIBB System has indication in incisional breast biopsy procedures for diagnostic purposes only and is not intended for therapeutic purposes.

Predicate Device: Mammotome® (K970565)

The 510(k) notification states the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not provide details of clinical studies, performance metrics, or study design (like sample sizes, ground truth establishment, or expert qualifications) that would typically be found in a full submission with supporting data. The focus of this summary is regulatory clearance through substantial equivalence, not detailed performance reporting.

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