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V-Loc™ 180 Absorbable Wound Closure Device is indicated for soft tissue approximation in where use of an absorbable suture is appropriate.

The V-Loc ™ 180 Absorbable Wound Closure Device is a suture prepared from a copolymer of glycolic acid and trimethylene carbonate. Each device has unidirectional barbs along the axis of the monofilament. The V-Loc ™ 180 Absorbable Wound Closure Device will be offered dyed with D&C Green No. 6 (21 CFR 74.3206) or clear (undyed) in sizes USP (EP) 2-0 (Metric 3), 0 (Metric 3.5) and 1 (Metric 4). They will be supplied in pre-cut lengths affixed to various needle types.

The input document is a 510(k) summary for the V-Loc™ 180 Absorbable Wound Closure Device. This document does not describe the acceptance criteria or results of a study in the format requested. It is a regulatory submission outlining the device description, indications, and substantial equivalence to predicate devices, but lacks detailed performance data with specific acceptance criteria and study results. Therefore, I cannot generate the requested table and answer the study-related questions based on the provided text.

Specifically, the "Performance Data" section merely states: "Performance testing was conducted to verify that the V-Loc™ 180 Absorbable Wound Closure Device is safe and effective and performs as intended." This general statement does not provide the specific metrics, criteria, or study outcomes needed to answer your request.

To fulfill your request, I would need a document that includes:

• A table or section explicitly listing acceptance criteria for various performance metrics (e.g., tensile strength, absorption rate, knot security, biocompatibility).
• Detailed results of the studies performed to demonstrate compliance with these criteria.
• Information on sample sizes, data provenance, ground truth establishment, expert qualifications, and study designs (e.g., standalone, MRMC) if applicable.

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