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The Smith & Nephew Legion Hinge Knee System is indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are incompetent.
6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are absent or incompetent.
   The Legion Hinge Knee System is for Cemented Use Only.

Subject of this premarket notification is a material change to the femoral component and tibial trav in the Legion Hinge Knee System and design changes to the femoral component and axle. The Legion Hinge Knee System is used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss possibility including the insertion points of the collateral ligaments or patella tendon, or comminuted fractures of the proximal tibial or distal femur. Components of this premarket notification include the following components:

• The femoral components manufactured from oxidized zirconium allov . (OXINIUM).
• Design changes to the femoral component and axle ●
• Tibial tray manufactured from Titanium alloy (Ti-6Al-4V). ●

The provided document is a 510(k) summary for the Smith & Nephew Legion Hinge Knee System. It describes a medical device, a knee joint femorotibial metal/polymer constrained cemented prosthesis, and its substantial equivalence to predicate devices. The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the regulatory submission for a physical medical device (knee implant) and focuses on mechanical performance testing and substantial equivalence to existing devices, not on the performance of an AI/ML algorithm or software.

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