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The EVOLUTION® MP Revision Femoral System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® MP Revision Femoral System is for cemented use only.

The EVOLUTION® MP Revision Femoral System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a stemmed distal femoral knee joint replacement implant for use in revision or a complicated primary total knee arthroplasty. The design features are summarized below:

• Manufactured from Cobalt Chrome Alloy
• Available in CS and PS design, sizes 3-7, left and right
• Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, EVOLUTION® Adaptive Tibial Inserts, ADVANCE® Patellae and ADVANCE® Stem Extensions
• System includes 4, 8 and 12 mm augments to fill bone voids in distal and/or posterior bone geometry

This document is a 510(k) Pre-Market Notification from the FDA for the EVOLUTION® MP Revision Femoral System. It is a regulatory approval document and, as such, does not contain the information requested in your prompt regarding acceptance criteria and study particulars for an AI/device performance study.

The device detailed in this document is a knee joint replacement implant. The document focuses on demonstrating substantial equivalence to a predicate device based on design features, materials, and nonclinical (mechanical) testing, not on the performance of a diagnostic AI algorithm.

Specifically, the document states:

• "E. Clinical Testing: Clinical data was not provided for the subject devices." This explicitly indicates that no clinical performance study, let alone one involving AI or diagnostic accuracy, was conducted or submitted.

Therefore, I cannot provide an answer to your detailed questions (acceptance criteria, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) because this document does not describe the kind of study you are asking about.

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