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Knee femoral components are single use devices implanted in the human knee during total knee arthroplasty. This knee is intended for cement use only.

The femorals are made of cast Zimaloy® Cobalt-Chromium-Molybdenum Alloy. They are hardened by the Co-Nidium™ Surface Hardening Process described in Section XI. They are available in left and right configurations. NexGen/Legacy Knee femorals cover a multitude of patient specific needs with the Cruciate Retaining (CR), Posterior Stabilizing (PS and L-PS), Cruciate Retaining Augmentable (CRA), and Constrained Condylar Knee (L-CCK) designs. Certain femorals can be augmented with stem extensions. The extensions come in a broad variety of straight and offset shapes as well as numerous lengths and diameters. These femorals will be available in precoat, porous, and option (NoCoat) versions.

This document is a Summary of Safety and Effectiveness for medical devices (NexGen® Complete Knee Solution and Legacy™ Knee System with Co-Nidium™ Surface Hardening Process). It describes the devices and their intended use but does not contain information related to acceptance criteria or the study data proving the device meets those criteria, as typically requested for AI/ML device evaluations.

Specifically, the document states: "The performance data submitted in the 510(k) demonstrated the improved wear resistance compared to nontreated femoral components." However, it does not provide the acceptance criteria, the specific study design, sample sizes, ground truth methodology, or expert qualifications that would be necessary to answer the questions posed.

Therefore, I cannot extract the requested information from the provided text.

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