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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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This system is to be used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss possibly including the insertion points of the collateral ligaments or patella tendon, or comminuted fractures of the proximal tibia or distal femur. Patients requiring hinged knees typically fall into one of four categories; 1) revision knee procedure 2) oncology 3) trauma or 4) severe varus/valgus primary knees.

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, ostecarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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 and 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 collateral ligament) are absent or incompetent.

The Legion Hinge Knee System is for Cemented Use Only.

Subject of this pre-market notification is the LEGION Hinge Knee system. This is an extension to the LEGION Revision system. This system broadens the complexity of cases which can be addressed with LEGION by offering a hinged option which can be used in cases of inadequate ligament stability of the knee or gross femoral/tibial bone loss. Instrumentation is to be minimized by using many of the LEGION Revision instruments. This system is to include femoral and tibial revision components, tibial inserts, distal femoral and proximal tibial segments, stems, cones and wedges as well as the instruments and trials required to implant the components. The tibial component includes a rotating platform option.

This document is a 510(k) premarket notification for the Smith & Nephew Legion Hinge Knee system. It is a submission to the FDA to demonstrate substantial equivalence to existing legally marketed devices, not a study evaluating the performance of the device against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in this document.

The document focuses on:

• Intended Use and Indications for Use: Describing the conditions for which the device is designed.
• Device Description: Outlining the components and functionality of the knee system.
• Substantial Equivalence Information: Comparing the device to predicate devices already on the market. This is the primary method used to "prove" the device's safety and effectiveness in a 510(k) submission – by demonstrating it is as safe and effective as a legally marketed device, not by presenting new performance data against specific acceptance criteria.
• FDA Clearance Letter: Indicating that the device has been cleared for market based on the substantial equivalence argument.

Therefore, I cannot provide the requested table of acceptance criteria, reported device performance, or details about a study evaluating these criteria from the provided text. The 510(k) process relies on demonstrating equivalence to predicate devices, not on proving performance against a set of new acceptance criteria through a specific study as would be seen for a novel device or in a clinical trial setting.

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