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

The NeoTract Anchor System consists of a single use delivery device that delivers up to two permanently implantable NeoTract Anchors. A NeoTract Anchor consists of one nitinol tube connected by nonabsorbable monofilament suture to a stainless steel pin with locking ring.

This document describes a 510(k) summary for the NeoTract Anchor System, a surgical suture device. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, the NeoTract Anchor (K061700).

Therefore, the provided text does not include information about AI/ML device performance or studies with acceptance criteria in the context of AI/ML. The device described, the NeoTract Anchor System, is a traditional medical device (surgical suture) and the supporting data pertains to biocompatibility, bench testing, and animal testing to demonstrate substantial equivalence, not AI algorithm performance.

Therefore, I cannot fulfill your request for the following reasons:

• No AI/ML Component: The provided submission is for a physical medical device (surgical suture) and does not involve an AI/ML algorithm.
• No Acceptance Criteria for AI/ML: Consequently, there are no acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies related to AI/ML to report.
• Study Type: The studies mentioned (biocompatibility, bench testing, animal testing) are standard for mechanical medical devices, not for evaluating AI performance.

If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the requested information.

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