(76 days)
The Acufex Double Armed Suture Needle is intended to be used to pass a suture through soft tissue which is need of repair. The Acufex Double Armed Suture Needle is intended to be used only with the Fast Pass Suture Punch. The Acufex Double Armed Suture Needle is indicated for use in open or arthroscopic Rotator Cuff and Bankart repairs.
The Acufex Double Armed Suture Needle is a sterile, single-use device manufactured from braided polyester and stainless steel.
This document is a 510(k) summary for a medical device (Acufex Double Armed Suture Needle) and does not contain information about acceptance criteria or a study proving device performance as it relates to AI/algorithm performance.
The provided text describes a traditional medical device (a suture needle) and its substantial equivalence to a predicate device. It is focused on demonstrating that the new device is as safe and effective as a previously cleared device, not on the performance of a software algorithm or AI.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to AI/algorithm performance from this document.
§ 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.