(105 days)
Surgisorb is indicated for use in general tissue approximation and or ligation, including use in ophthalmic procedures but not for use in cardiac or neurological procedures.
Not Found
I am unable to provide a description of acceptance criteria and study details based on the provided text. The document is an FDA clearance letter for a medical device (Surgisorb Surgical Suture) from 1999. It states that the device is "substantially equivalent" to previously regulated devices and outlines limitations and regulatory requirements.
However, the provided text does not contain any information about:
- Specific acceptance criteria for device performance.
- Details of any study that proves the device meets acceptance criteria (e.g., performance metrics, statistical results).
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training sets.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
The letter focuses on regulatory approval and classification based on substantial equivalence, not on the detailed results of a performance study.
§ 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.