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The Surg Tech GENOLL™ system is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only.

The SurgTech GENOLL"Total Knee System is used for total knee arthroplasty in skeletally mature individuals. The system consists of a CoCr alloy Posterior Stabilized (PS) femoral component (10 sizes, Left and Right), a CoCr alloy tibial baseplate (10 sizes), a conventional polyethylene PS tibial bearing insert (5 sizes with 5 thicknesses each) and a conventional polyethylene patella (3 sizes). Instrumentation necessary for proper implantation is also included.

The provided text is related to an FDA 510(k) premarket notification for a medical device called the "SurgTech GENOLL™ Total Knee System." This document is a clearance letter, not a description of an AI/ML-based device or its performance study.

Therefore, none of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study methods can be found in the provided text.

The document explicitly states under section (b)(2) "Clinical testing:" that "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This indicates that the clearance was based on demonstrating equivalence to predicate devices through similarities in intended use, design, materials, packaging, sterilization, and mechanical performance, rather than through
clinical or AI/ML performance studies.

The acceptance criteria listed in the document are for non-clinical testing of the physical components (e.g., Baseplate Fatigue, Constraint, Contact Area, PS Post Fatigue, Tibial Insert/Baseplate Disassembly, Bacterial endotoxins), not for an AI/ML system's diagnostic or predictive performance.

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and study data for an AI/ML device.

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