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The Holycon Synthetic Absorbable Sutures 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.

The Holycon Synthetic Absorbable Sutures are multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

The Holycon Synthetic Absorbable Sutures are composed of PGLA suture and needle.

The Holycon Synthetic Absorbable Sutures are composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); they are coated with copolymer of 30% glycolide and 70% lactide and calcium stearate. The PGLA suture is dyed suture.

The needles are available in four types: Taper, Cutting, Spatula and Blunt. The material of needles is stainless steel.

The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40, USP 40 and USP 40 .

The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

This document is a 510(k) summary for the Holycon Synthetic Absorbable Sutures. It describes the device's characteristics and its substantial equivalence to a predicate device, but it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as this document pertains to a traditional medical device (surgical sutures) and its regulatory clearance process through substantial equivalence, not AI/ML performance evaluation.

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