(30 days)
The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.
The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.
This FDA 510(k) clearance letter pertains to a surgical suture, the HS Fiber® Suture, and not an AI/ML powered device. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML (e.g., test set, ground truth, expert consensus, MRMC study, training set) cannot be fulfilled based on the provided document.
The document states: "The updates being proposed are limited to the labeling, no additional performance testing or biological evaluation was required." This indicates that no new performance studies (of any kind, let alone AI/ML specific ones) were conducted for this particular 510(k) submission (K252201). The device is deemed substantially equivalent to a previously cleared predicate device (K231163) based on the technological identity and minor labeling changes.
Therefore, I cannot provide the requested information for an AI/ML device 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.