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For E-XPE Insert (CR, PS and UC type) and Patella:
The device 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 can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.

For E-XPE Insert (PSA type)
This device 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended for cemented use only.

The subjected device includes E-XPE Tibial insert (CR, PS, UC and PSA type) and E-XPE Patella. It is an extension to the previously cleared "UNITED" U2 Total Knee System (K082424, K103733, K131864, K132752 and K150829). The design rationale and indication for use are identical to the previously cleared "UNITED" U2 Total Knee System.

The provided document is a 510(k) summary for the U2 Total Knee System E-XPE Products. It focuses on demonstrating substantial equivalence to pre-existing predicate devices for a medical device, specifically a knee implant. As such, it details pre-clinical performance data (mechanical tests) and explicitly states "None provided" for clinical performance data.

Therefore, it does not contain the information required to answer the prompt, which is about acceptance criteria and study results for an AI/algorithm-based medical device. The prompt is looking for details about an AI's performance, such as:

• Accuracy/performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test and training sets related to image or data analysis
• Ground truth establishment by expert readers or pathologists
• Human-in-the-loop studies (MRMC studies)
• Adjudication methods for AI performance validation

None of this type of information is present in the provided text, as it describes a physical implant and its material/mechanical testing.

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