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Total knee replacement is indicated for patients suffering from 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. These devices are intended for cemented use only.

Stemmed tibial baseplate components are part of the MG II Total Knee System. They incorporate a central stem with available modular stem extensions. There are three versions of stemmed tibial baseplate components: Porous, PMMA Precoat, and Option (non-coated). They are available in the same size range, and are compatible with the same articular surface components, as the predicate device.

The provided document is a 510(k) summary for a medical device (MG II™ Total Knee System Stemmed Tibial Baseplate Components) and a clearance letter. This type of regulatory submission for orthopedic implants differs significantly from the type of information you'd find for AI/ML-based medical devices.

Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for an AI/ML algorithm.

Instead, it's a submission for a physical orthopedic implant and focuses on demonstrating substantial equivalence to a predicate device based on design modifications and non-clinical performance (mechanical testing).

Here's why the requested information isn't present:

• No AI/ML Component: The device is a knee prosthesis, not an AI/ML diagnostic or predictive tool.
• Regulatory Pathway: The 510(k) pathway for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing and comparison of materials, design, and intended use, rather than clinical efficacy studies involving human readers or AI performance metrics.
• "Performance Data (Nonclinical and/or Clinical)" Section: The document explicitly states:
  • "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device." This refers to mechanical or material testing, not AI performance.
  • "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This confirms no clinical studies were performed, which would be essential for AI/ML device validation.

In summary, this document does not describe the acceptance criteria and study proving an AI/ML device meets those criteria because the device in question is a physical orthopedic implant, not an AI/ML system.

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