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The Contour Meniscus Arrow™ is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascular area of the meniscus (e.g. "red-red" and "red-white" zones) in conjunction with immobilization during healing.

The device description of the Contour Meniscus Arrow™ is as follows.

• Composed of poly-L/D-polylactide copolymer
• Length 10, 13 and 16mm
• Diameter 1.1mm

The provided text is a 510(k) summary for the Contour Meniscus Arrow™, which focuses on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the manner requested (e.g., clinical performance, efficacy testing with specific metrics like sensitivity, specificity, or accuracy).

Instead, the document asserts substantial equivalence based on:

• Identical intended use.
• Same operating principle.
• Same basic design (with minor modifications to raw material and design).
• Same manufacturing, packaging, and sterilization processes.
• Same shelf life.

The 510(k) summary is a regulatory document to clear a medical device for marketing, not a scientific publication detailing a study that meets specific acceptance criteria in terms of analytical or clinical performance metrics. The FDA's letter (K012334/S001) confirms the substantial equivalence determination.

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not present in this type of regulatory submission. The device's "performance" in this context refers to its physical and functional characteristics being substantially equivalent to predicates, implying similar safety and efficacy without needing new clinical studies if the differences are minor and do not raise new questions of safety or effectiveness.

Based on the provided text, the answer is that the document does not contain the information requested about acceptance criteria and a study proving the device meets those criteria in terms of clinical or analytical performance metrics.

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