(251 days)
Absorbable Surgical Suture USP/EP is indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of this suture in cardiovascular, neurological and micro surgery have not been established.
Not Found
Unfortunately, the provided document does not contain the specific information requested regarding "acceptance criteria and the study that proves the device meets the acceptance criteria." The document is a clearance letter from the FDA for a device called "Polycryl," an absorbable poly(glycolide/L-lactide) surgical suture.
While it mentions that the device is "substantially equivalent" to legally marketed predicate devices, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the number/qualifications of experts for a test set.
- Information on adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
- Details about the training set size or how its ground truth was established.
The document is purely an FDA clearance letter confirming substantial equivalence under a 510(k) pathway, and therefore does not delve into the detailed study results or performance metrics associated with acceptance criteria that would typically be found in a clinical study report or a more comprehensive FDA submission summary.
§ 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.