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The Ultra™ Biopsy Device is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Our company is presently authorized by the Food and Drug Administration to manufacture disposable soft tissue biopsy needles, K921418. This device is to be the reusable handle gun that will compete with the products that currently use the biopsy needles covered by this 510 (k) .

Here's an analysis of the provided text regarding acceptance criteria and study details for the Ultra™ Biopsy Device. However, it's immediately apparent that the provided document does not contain the information requested for acceptance criteria and the specifics of a study proving device performance as outlined in your prompt. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than reporting detailed performance studies against specific acceptance criteria.

Therefore, I will populate the table and answer the questions indicating that the information is "Not provided in the document."

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the Ultra™ Biopsy Device does not detail specific acceptance criteria or report a study proving the device meets such criteria. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for market clearance.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not provided in the document.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): 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:

Not provided in the document.

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

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:

Not applicable. The device described is a reusable biopsy handle gun, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant. The document does not describe any such study.

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

Not applicable. The device is a physical medical instrument (a biopsy handle gun), not an algorithm. Therefore, a standalone algorithm performance study is not relevant. The document does not describe any such study.

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

Not provided in the document.

8. The sample size for the training set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or algorithms. The document does not describe any training data for an algorithm.

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

Not applicable, as there is no training set for a physical device.

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