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The BIO-EUROLIG® screw is intended to provide interference fixations of bone-tendonbone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.

The Bio-Eurolig® screw is a bioabsorbable interference screw made of Poly-Lactid Acid (PLA) and available in 3 diameters (7, 8 and 9mm) and in 2 lengths (25 and 30). They are delivered sterile and are single use.

The provided text does not contain information about acceptance criteria or a study proving that the BIO-EUROLIG® SCREW meets specific performance benchmarks. The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a specific study against predefined acceptance criteria.

The "Performance Data" section states: "Risk to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. Testing were performed to characterize the functionality, durability and safety of the Bio-Eurolig® screws." However, it does not elaborate on what these tests entailed, what the acceptance criteria were, or what the reported performance was.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies. This information is typically found in detailed test reports or clinical study summaries, which are not part of the provided 510(k) submission.

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