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The EVOLUTION® Revision CCK 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® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:

• Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
• . Available in 8 standard sizes, left and right
• Available in 2 plus sizes, left and right
• . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap

The provided text describes the MicroPort Orthopedics EVOLUTION® Revision CCK System, a knee joint prosthesis. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a diagnostic or AI/software device.

Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design features, materials, and non-clinical performance testing. The information provided is primarily related to mechanical and material performance rather than diagnostic accuracy or human performance with or without AI.

Therefore, I cannot fulfill all parts of your request as posed because the document is not an "acceptance criteria study" in the sense you are asking for. It is a regulatory submission demonstrating substantial equivalence.

Based on the provided text, I can extract information relevant to non-clinical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test in a pass/fail format alongside numerical performance values. Instead, it describes comparative performance against a predicate device. The general "acceptance criteria" can be inferred as performing "as well as" or "greater than" the predicate device for various mechanical properties to demonstrate substantial equivalence.

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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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