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Nanova™ Interference Screw is indicated for the fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee. The 7, 8 and 9mm x 23mm screws are also indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

Nanova™ Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The device is made from a copolymer of absorbable Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanova™ Interference Screws are single use, prescription, long term implant, no drug.

The provided document, a 510(k) premarket notification, describes the Nanova Interference Screw, a medical device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document specifies that non-clinical performance testing was completed, comparing the device's mechanical and performance testing with a predicate device. It states, "Mechanical and performance testing was compared with the predicate, which resulted in similar mechanical and performance to the predicate (all testing passed)." It also mentions biocompatibility testing per ISO 10993 (all testing passed) and pyrogenicity testing (determined to be nonpyrogenic).

Crucially, under "Clinical Performance Testing," the document explicitly states: "Clinical performance data was not included."

Therefore, based on the provided text, I cannot answer the questions about acceptance criteria for AI/ML performance, study details, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies. These elements are typically associated with the evaluation of AI/ML-driven medical devices, which this submission does not appear to be. This is a submission for a physical medical device (an interference screw) where substantial equivalence to existing devices is demonstrated through non-clinical testing.

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