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Trabecular Metal Knee System Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.

The Trabecular Metal Knee System Augments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System, the Trabecular Metal Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.

This document is a 510(k) summary for a medical device (Trabecular Metal Knee System Augments) and explicitly states that no new performance data or studies were conducted for this submission:

• "The predicate and subject devices are identical; performance Performance Data: characteristics therefore remain as documented in the predicate submission (K024161)."

Because of this statement, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The submission relies entirely on the performance established for its predicate device (K024161).

Therefore, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not provided as no new studies were performed.
2. Sample sized used for the test set and the data provenance: Not applicable as no new studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new studies were performed.
4. Adjudication method for the test set: Not applicable as no new studies were performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical knee implant augment, not an AI software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical knee implant augment, not an algorithm.
7. The type of ground truth used: Not applicable as no new studies were performed.
8. The sample size for the training set: Not applicable as no new studies were performed, and this is a physical device, not a software algorithm.
9. How the ground truth for the training set was established: Not applicable as no new studies were performed, and this is a physical device, not a software algorithm.

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