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The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

The Eviva Stereotactic Guided Breast Biopsy System is a hand-held biopsy device that is marketed for guidance with stereotactic imaging. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

The provided text is a 510(k) summary for the Eviva Stereotactic Guided Breast Biopsy System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, detailed results of performance testing, or information about the studies asked for in your request.

Here's a breakdown of what is and isn't available based on the provided document:

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

• The document does not provide a table of acceptance criteria and reported device performance in the typical sense (e.g., sensitivity, specificity, accuracy, or quantitative metrics for biopsy success).
• It generically states: "Bench testing of the Eviva Stereotactic Guided Breast Biopsy System including functional testing, biocompatibility, sterilization and package testing demonstrated equivalent performance, and showed to be as safe and effective as the predicate device, and met all acceptance criteria."
• And in the conclusion: "The Eviva Stereotactic Guided Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."
• These are assertions that acceptance criteria were met, but the criteria themselves and the specific "reported performance" against those criteria are not detailed.

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 present in the document. The document refers to "bench testing" but does not specify sample sizes or data provenance for any clinical or performance studies.

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 document. The filing does not describe a study involving expert-established ground truth. The device is a biopsy system, and the ground truth for diagnosis typically comes from pathology of the acquired tissue, not from expert consensus on images.

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

• This information is not present in the document, as no such study is described.

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 information is not present in the document. The device is a biopsy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be applicable or expected for this device.

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

• This information is not present in the document. The device is hardware (a biopsy system), not a standalone algorithm.

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

• For the intended use of a breast biopsy system, the ultimate ground truth for a diagnosis from the tissue collected would be pathology. While the document doesn't explicitly state "pathology was used as ground truth," this is the standard for such devices. The "extent of histologic abnormality" is mentioned multiple times, strongly implying pathology as the diagnostic gold standard for the tissue obtained.

8. The sample size for the training set

• This information is not present in the document. The device is a mechanical biopsy system, not an AI model that requires a training set in that context.

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

• This information is not present in the document, as it's not applicable to the type of device.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through functional, biocompatibility, sterilization, and package bench testing. It does not include detailed clinical study data, performance metrics against specific acceptance criteria, or information about AI algorithm performance studies which are typically associated with the questions asked. The "acceptance criteria" referred to are related to the engineering and safety performance of the device rather than diagnostic accuracy as would be assessed in clinical reader studies for imaging software.

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