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Novafil** and Vascufil** Sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.

Novafil** non-absorbable monofilament surgical sutures are composed of polybutester, a copolymer of butylene terephthalate and polytetramethylene ether glycol.

Vascufil** coated non-absorbable monofilament surgical sutures are composed of polybutester, a copolymer of butylene terephthalate and polytetramethylene ether glycol. The suture is coated with POLYTRIBOLATE**, an absorbable polymer of e-caprolactone / glycolide / poloxamer 188.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The provided text is a 510(k) summary for a medical suture (Novafil and Vascufil) to establish substantial equivalence to a predicate device. It discusses the device description, intended use, and regulatory classification, but it does not detail performance metrics, test methodologies, or clinical studies that would be relevant to an AI/ML system's evaluation.

Therefore, I cannot provide the requested information.

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