(125 days)
UniCryl is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.
Not Found
The document provided is a 510(k) premarket notification letter from the FDA for a device called "UniCryl," which is an absorbable poly(glycolide/L-lactide) surgical suture.
This type of FDA letter confirms substantial equivalence to a predicate device and permits marketing. It is not a study report or clinical trial document. Therefore, the provided document does not contain any of the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The 510(k) process for devices like sutures primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through material characterization, mechanical testing, and sometimes biocompatibility testing. It generally does not involve clinical studies with human readers or AI algorithms as would be the case for diagnostic imaging AI.
To answer your request, a different type of document, such as a clinical study report or a detailed 510(k) summary (which might include performance data if specifically required for a novel aspect), would be necessary.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.