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The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.

Implantation of the fixation device is accomplished through arthroscopy or arthrotomy.

The Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C violet #2 at less than 0.01 wt.8.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The document is a 510(k) summary for a Meniscal Repair Device, detailing its intended use, description, and substantial equivalence to a predicate device. It includes regulatory correspondence from the FDA.

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The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.

The Meniscal Repair Device is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.

The provided document is a 510(k) summary for a Meniscal Repair Device (Bone Screw) and details its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/machine learning performance.

The study referenced is a non-clinical comparative pull-out strength test, which is a biomechanical test for a physical device, not an evaluation of an AI or algorithmic device.

Therefore, I cannot extract the requested information (points 1-9) as it pertains to AI/machine learning acceptance criteria and studies from this document. The document describes a traditional medical device (a bone screw) and its safety and effectiveness in comparison to existing devices.

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