(305 days)
TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures
Absorbable Surgical Suture,Synthetic (Polyglycolic Acid)
The provided text is related to a 510(k) premarket notification for a medical device: "TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture."
This document is a regulatory approval letter from the FDA, a 510(k) summary, and an indications for use statement. It does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any details regarding sample sizes, ground truth, expert qualifications, or MRMC studies.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices based on the information provided in the 510(k) submission. This substantial equivalence is typically established by demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document focuses on regulatory approval based on equivalence, not on a detailed clinical or performance study with defined acceptance criteria in the way you've described.
§ 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.