(101 days)
UniMide is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Not Found
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device called UniMide, which is a nonabsorbable polyamide surgical suture.
This document does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter primarily focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the manufacturer to market UniMide.
Therefore, I cannot fulfill your request for details on acceptance criteria and study information.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; 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.