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The GENFlex2 Total Knee System is intended for:
● Total knee replacement due to osteoarthritis, osteonecrosis
rheumatoid arthritis, and/or post-traumatic degenerative
problems.
● Revision of failed previous reconstructions where
sufficient bone stock and soft tissue integrity are present.
The device is intended for cemented use only.

The GENflex2 System is a cemented total knee joint replacement system comprised of modular components with varying sizes available for each component. The purpose of this Special 510(k) is to modify the geometries of the Posterior Stabilized and the Cruciate Retaining tibial insert and femoral component. These components are manufactured from EXp Vitamin E Polyethylene, Conventional Polyethylene and Cobalt Chrome Alloy. Each component is available in a range of sizes that complement each other.

I am sorry, but based on the provided text, there is no information about an AI/ML-based medical device, a study proving its performance, acceptance criteria, or any of the specific details you requested (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details).

The document is a 510(k) premarket notification for a traditional medical device: the "GENflex2 Total Knee System," which is a knee joint replacement system. The review focuses on its substantial equivalence to predicate devices based on materials, geometry, and mechanical performance (e.g., static and fatigue testing, engineering analyses of contact area).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance and validation.

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