(19 days)
The Arthrex FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
Arthrex FiberWire® configurations consist of single strand suture with or without needles, suture with stiffened ends, suture chains, and FiberTape®.
The provided text is a 510(k) summary for the Arthrex FiberWire® suture. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert involvement, or adjudication methods for an AI/ML powered device.
The document states that the Arthrex FiberWire® is "substantially equivalent to the predicate Arthrex FiberWire®" and that "Any differences between the FiberWire and the predicate K041589/K041553 are considered minor and do not raise questions concerning safety and effectiveness."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone performance details.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
This document is focused on regulatory clearance for a medical suture based on substantial equivalence to existing predicate devices, not on the performance characteristics of an AI/ML system.
§ 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.