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The DePuy Coordinate II Revision Knee System is indicated for use with bone cement as either a primary or revision tricompartmental knee replacement system.

The Coordinate II Revision Knee System is a design modification of the Coordinate Revision Knee System which was previously cleared by FDA for cemented use. The design modifications consist of the following: stem extensions for femoral and tibial components will be threaded rather than tapered; central posts on the femoral components and tibial trays will be modified to accept the threaded stem extensions; all tibial trays will be manufactured from cast Co-Cr-Mo; and the articular surface of the tibial inserts will be modified to be slightly more conforming.

This document describes a medical device, the DePuy Coordinate II Revision Knee System, which is a knee prosthesis. The submission is a 510(k) for a design modification of an already cleared device.

Based on the provided text, the document focuses on establishing substantial equivalence to a predicate device for this specific medical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of analytical or clinical performance metrics typically associated with AI/ML devices or diagnostic tools.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study design as requested for an AI/ML device. The provided text is for a traditional medical device (a knee prosthesis) and the "study" described is a comparison of design features to establish substantial equivalence under the 510(k) pathway, not a performance study in the context of diagnostic accuracy or clinical outcomes that would involve the requested metrics.

In summary, the provided input does not contain the information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or AI/ML performance metrics.

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