(42 days)
SERRALENE™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a medical device: Serralene™ Non-absorbable Surgical Sutures. This document does not contain the information requested about acceptance criteria and a study proving the device meets them.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on meeting specific, pre-defined acceptance criteria through a performance study. While the manufacturer would have performed tests to ensure the device's safety and effectiveness for substantial equivalence, the clearance letter itself doesn't typically detail those studies in the way you've outlined for AI/diagnostic devices.
Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter granting clearance for marketing the device based on its substantial equivalence to an existing product.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.