(99 days)
UniSilk 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 510(k) premarket notification letter from the FDA regarding the UniSilk surgical suture. It establishes substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them, as none of that information is present in the provided document. The document pertains to a traditional medical device (suture) and its regulatory clearance, not an AI/ML diagnostic or prognostic tool.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.