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Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Modified Polysorb* Suture is composed of a glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.

The provided text is a 510(k) summary for a "Modified Polysorb Suture." This document focuses on demonstrating substantial equivalence to a predicate device (Polysorb Suture, K970863) to gain market clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way one would typically describe a clinical or algorithmic performance study.

Medical devices like sutures are often evaluated based on material properties, biocompatibility, and mechanical strength to ensure they function as intended and are safe for use. However, the provided text does not detail the specific tests conducted or their results.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I discuss sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case studies, as these types of studies are not described in the given documents for this product.

Instead, the document primarily focuses on:

• Device Description: Modified Polysorb Suture is composed of a glycolide/lactide copolymer and coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.
• Intended Use: Soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
• Materials: All component materials are in accordance with ISO Standard # 10993-1, which addresses biocompatibility.
• Predicate Device: Polysorb* Suture (K970863). The substantial equivalence is based on the similarities in composition, intended use, and general characteristics to this already legally marketed device.
• FDA Clearance: The FDA found the device substantially equivalent to transitional devices reclassified into Class II, subject to general controls and specific limitations regarding manufacturing materials.

For a medical device like a suture, performance would typically be evaluated through:

• Mechanical Testing: Tensile strength, knot security, degradation profile.
• Biocompatibility Testing: According to ISO 10993 standards (which is mentioned for the materials).
• Sterilization Validation: Ensuring the device can be effectively sterilized.
• In vivo animal studies: To assess tissue reaction, absorption, and wound healing in a biological environment.

However, the provided K981935 summary does not contain the detailed results of such studies. It only states that the materials conform to ISO 10993-1 and that manufacturing processes and material changes would require new premarket notification.

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