(37 days)
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.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.