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The NeoTract Anchor is intended for the approximation of tissue in open surgical procedures.
The NeoTract Anchor is intended for the approximation of soft tissue in open surgical procedures.

The NeoTract Anchor is designed to approximate tissue following open surgical procedures.

This submission (K061700) refers to a 510(k) Premarket Notification for the NeoTract Anchor, a surgical device intended for tissue approximation. The provided text, however, does not contain a study that presents acceptance criteria and reported device performance in the way typically expected for an AI/ML device.

This document describes a medical device called the "NeoTract Anchor" which is a physical surgical device (a staple/anchor for tissue approximation), not an AI/ML software device. The "Testing Summary" section notes that "Simulated use and performance testing was conducted on the NeoTract Anchor and compared to the predicate device, Onux Salute," and that "All components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide the quantitative or qualitative details of these tests, or the specific acceptance criteria.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and studies, as this document is not about such a device. The information requested (sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML algorithms and is not addressed in this 510(k) submission for a physical surgical anchor.

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