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The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are intended to be used with Kinemax® and Kinemax® Plus tibial and patellar components as a total knee system. These components are intended to be used in total knee replacement procedures indicated due to inflammatory or noninflammatory joint disease, failed previous prosthesis, or trauma. Specifically, this femoral component is intended to be used in situations where a stemmed component is desired to provide additional stability. This femoral component allows the surgeon to use (as an option) femoral spacers to augment bone loss on the distal or distal/posterior surfaces of the femur. These components are intended to be implanted using bone cement.

Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers

This looks like a 510(k) summary for a medical device (Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers). However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The provided text is a summary of the device, its intended use, classification, and a list of substantially equivalent predicate devices. It does not include:

• Performance metrics (e.g., accuracy, sensitivity, specificity, mechanical strength, durability, wear rates).
• Any details of a clinical or bench-top study design.
• Sample sizes for any tests.
• Information about expert review or ground truth establishment.
• Results from any performance tests.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided.

To answer your request, I would need a document (e.g., a clinical study report, a bench testing report, or a comprehensive 510(k) submission that includes performance data) that details:

1. Specific performance metrics being assessed (e.g., wear, fatigue strength, range of motion, clinical outcomes like pain reduction or function).
2. Quantitative acceptance criteria for each metric.
3. Details of the study performed (bench testing, animal study, clinical trial) including methods, sample sizes, and results.

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