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The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, 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 cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

U2 Cemented Femoral Component-CR Type is manufactured from cast Co-Cr-Mo alloy confirming to ASTM F75. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm/ 56mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7. Fixation of the femoral component to the femur is achieved using bone cement.

1. Table of acceptance criteria and reported device performance:

Note: The document states that the submission was prepared in accordance with the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The specific quantitative acceptance criteria are not explicitly detailed in this summary but are implied to be those outlined in this guidance document.

2. Sample size used for the test set and the data provenance:

• Sample size for the test set: Not applicable. The "Performance Data" section explicitly states "None provided as a basis for substantial equivalence" for clinical performance data. The device's safety and effectiveness were evaluated through non-clinical (bench) testing.
• Data provenance: Not applicable. No clinical data (which would have provenance) was provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The study relies on non-clinical performance data (bench testing) rather than clinical data requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. The study relies on non-clinical performance data (bench testing).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a medical device (femoral component for knee replacement) and not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device and does not involve an algorithm. The "standalone" performance here would refer to the physical device's mechanical performance, which was assessed through bench testing as described in the "Non-clinical Performance" section.

7. The type of ground truth used:

• Bench Testing Standards: The ground truth for the non-clinical tests would be defined by established engineering and biomechanical standards (e.g., ASTM standards, or those referenced in the FDA's "Class II Special Controls Guidance Document") for the performance metrics being evaluated (e.g., range of motion, contact pressure, fatigue strength). The device's performance was compared against these predefined physical and mechanical thresholds for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a medical device, not an AI model.

9. How the ground truth for the training set was established:

• Not applicable. This is a medical device, not an AI model.

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