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This device 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, 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 intended to be used as part of a cemented knee system.

These components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene. Both the modified and predicate devices are crosslinked by exposure to electron-beam (e-beam) radiation.

Except for a minor modification to the patellar cutout, Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components are identical to the predicate device. The modification does not change the intended use or the fundamental scientific technology. It is packaged and sterilized using the same materials and processes.

The provided document is a 510(k) premarket notification for a medical device: the Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component. This document is related to a joint replacement component, not an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, ground truth, and expert involvement (which are typical for AI/ML device evaluations) are not applicable to this submission.

Here's a breakdown of why the requested information cannot be provided from this document:

• Device Type: The device is a physical knee joint component made of Ultra-High Molecular-Weight (UHMWPE) polyethylene, crosslinked by electron-beam radiation.
• Regulatory Pathway: This is a 510(k) submission, demonstrating substantial equivalence to a predicate device (NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K003910).
• Performance Data: The document states, "Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device." However, it does not provide details of this performance testing, acceptance criteria, or the specific results. The focus of the 510(k) summary is on comparing the new device to the predicate device and confirming the modification (minor change to the patellar cutout) does not alter intended use or fundamental scientific technology.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device evaluation criteria. The document simply confirms that performance testing was done and found the device substantially equivalent.

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