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The Bio-Mini Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to secure soft tissue, such as ligaments, tendons, or joint capsules, to the bone, thereby stabilizing the damaged area during the healing period.

The Linvatec Bio-Mini-Revo™ suture anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with one non-absorbable, braided, ultrahigh molecular weight polyethylene suture. The Bio-Mini-Revo™ suture anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.

The requested information is not available in the provided document. The document is a 510(k) summary for a medical device (Bio-Mini Revo Suture Anchor) and primarily discusses its substantial equivalence to predicate devices, device description, and intended use. It does not contain details about specific acceptance criteria or a study proving the device meets them in the way described in the request (e.g., performance metrics, sample sizes, expert involvement, and ground truth establishment). The document is a regulatory submission for premarket notification, not a clinical or performance study report.

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