(95 days)
The Arthrex Meniscal Cinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
The Arthrex Meniscal Cinch is an implantable suture retention device consisting of FiberWire suture and small PEEK tubes. The FiberWire suture is offered in a #2-0 size.
The provided text describes a medical device, the Arthrex Meniscal Cinch, and its 510(k) summary for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (K072322, Smith & Nephew ULTRA FAST-FIX & ULTRA FAST-FIX AB Meniscal Repair Systems) based on common functionality and intended use. It states: "Testing of the Arthrex Meniscal Cinch compared to that of the predicate K072322 FAST-Fix support the common functionality and intended use as well as substantial equivalence of the device."
The document explicitly states: "Minor differences between the Arthrex Meniscal Cinch and the predicate device do not raise any questions concerning safety and effectiveness and has no apparent effect on the performance, function, or intended use of this device."
Therefore, based on the provided text, I cannot complete the table or answer the specific questions regarding acceptance criteria and a study proving their fulfillment as this information is not present. The document focuses on regulatory approval through substantial equivalence, not detailed performance studies or predefined acceptance criteria.
§ 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.