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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.

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