(62 days)
The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.
The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a barbed suture manufactured from #1 USP nylon monofilament. The polyester sheath is coated with beeswax.
The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex SoftStitch device. It pertains to a surgical suture and implantable retention device, not an AI-powered diagnostic tool. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance metrics, ground truth, expert adjudication, or MRMC studies is not applicable and cannot be extracted from this document.
The document details the substantial equivalence of the modified Arthrex SoftStitch to a previously cleared predicate device (K190707) and a reference device (K203117). The performance data cited focuses on mechanical strength (tensile testing) and biocompatibility (bacterial endotoxin testing), which are standard for medical devices like sutures, but not relevant to AI/ML device performance.
Therefore, I cannot fulfill the request as the provided text does not contain information about the development and validation of an AI-powered medical device.
§ 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.