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The Acculoc Total Knee System is indicated in knee arthroplasty for relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The Acculoc Total Knee System is designed for cemented use only.

The Acculoc Tibial tray is a component of "Acculoc Total Knee System" cleared under K170753 which consist of Femoral component, Tibial tray, Tibial Insert, Patella components and Instrumentation- Acculoc Total Knee Instrumentation System for use with the implants components. The current premarket notification is related to the addition of the Acculoc Tibial tray manufactured from CoCrMo alloy (Cobalt-chromium-molybdenum alloy), this is same size and same design with the predicate device tibial tray (K170753) and only the material is different. The Tibial tray AP and ML size ranges are exact same as the predicate device Tibial tray (K170753).

The provided text is a 510(k) premarket notification for a medical device called the "Acculoc Total Knee System." It specifically focuses on an update to this system, adding a new material (CoCrMo alloy) for the Tibial tray component.

This document does not contain information about acceptance criteria for device performance in the context of an AI/ML algorithm or a clinical study proving its performance against such criteria. Instead, it details:

• Device Name: Acculoc Total Knee System
• Regulatory Information: Product code, regulatory class, regulation number.
• Intended Use/Indications for Use: What the device is designed to do and for whom.
• Predicate Devices: Previously cleared devices that the current one is being compared against for substantial equivalence.
• Device Description: Information about the components and materials.
• Performance Testing: Refers to mechanical and pyrogenicity testing of the physical implant components against relevant ASTM/ISO standards, not clinical performance or performance of a diagnostic algorithm. This is typical for orthopedic implants to demonstrate safety and durability.

Therefore, I cannot answer the questions about acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance because the provided text does not describe such a study or requirements. The "performance testing" mentioned is for the physical knee implant itself, not an AI or diagnostic device.

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