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STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable single-use surgical suture device composed of a copolymer of glycolide and (epsilon) s-caprolactone. The device contains IRGACARE®: MP (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m. The colorant employed is D&C Violet No.2, in

This document describes a 510(k) premarket notification for a medical device, specifically a surgical suture. It does not contain information about an AI/ML medical device, which would typically include acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert qualifications, etc.), or details of human reader studies (MRMC).

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as the provided text pertains to a traditional medical device (surgical suture) and not an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than the detailed clinical validation studies common for AI/ML products.

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