(242 days)
CRYLREX® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
CRYLREX® is a sterilized medical device composed with multifilament absorbable, braided, coated suture, 90% glycolide and 10% L-lactide, with needle, stainless steel SUS 304. CRYLREX® Suture is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is available both dyed and undyed. CRYLREX® Suture is coated with poly(glycolideco-lactide)(30/70) and calcium stearate. The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70 days.
I apologize, but the provided text describes the 510(k) premarket notification for a surgical suture (CRYLREX®), not an AI-powered medical device or software.
Therefore, the document does not contain any information about:
- Acceptance criteria for an AI device's performance
- Standalone (algorithm only) or human-in-the-loop performance studies
- Sample sizes for training or test sets for an AI algorithm
- Ground truth establishment by experts
- Multi-reader multi-case (MRMC) comparative effectiveness studies
The document focuses on demonstrating substantial equivalence to a predicate surgical suture through:
- Bench testing to verify meeting design specifications and various USP and ISO standards related to physical properties (diameter, tensile strength, needle attachment), sterility, biocompatibility, and shelf life.
- Comparison of physical and material properties of the proposed suture to a predicate device.
To answer your request, I would need a document describing the regulatory submission for an AI-powered medical device that involves performance studies and clinical evaluations.
§ 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.