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The LOSPA Modular Knee System is intended for the treatment of diseases as follows:

· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;

· Post-traumatic loss of knee joint configuration and function;

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;

· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

The LOSPA Knee System is intended for cemented application only.

The LOSPA Modular Knee System components are similar to "LOSPA Total Knee System" cleared under K110404, K121037 & K130673 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation and are Patella Femoral Tibial Knee Prosthesis Systems, intended for cemented total knee arthroplasty, and all have same indications for use. The subject components, is a line extension to include extension stems with stem plugs and offset adaptors, distal and posterior femoral augments.

The provided text describes a 510(k) premarket notification for the LOSPA Modular Knee System. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in relation to an AI system.

The document is a clearance letter from the FDA, a 510(k) summary, and indications for use for a medical device (a knee replacement system). The "Performance Testing - Bench" section describes mechanical tests performed on the physical knee implant components to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI system.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.

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