(131 days)
S&T Microsurgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
S&T Microsurgical Suture
I am sorry, but the provided text from the FDA 510(k) approval letter (K031531) for the "S&T Microsurgical Suture" does not contain information regarding acceptance criteria or studies proving the device meets those criteria in the way you've described.
This document is a letter of substantial equivalence, which means the FDA has determined that the "S&T Microsurgical Suture" is as safe and effective as a legally marketed predicate device. The information typically requested in your prompt (e.g., specific performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, details of AI assistance, effect sizes, training set details) is not part of this type of FDA communication.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, often through comparison of technological characteristics, indications for use, and a summary of performance data (which might include bench testing, animal studies, or limited human clinical data, but usually not in the detailed format you're asking for). It does not typically involve the rigorous establishment of acceptance criteria and the publication of detailed study results as one might find for a novel device or a PMA.
Therefore, I cannot extract the requested information from the provided text.
§ 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.