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Partial replacement of the articulating surfaces of the knee when only one side of the Joint is anceced due to the compartmental primary degenerative or posttraumatic arthritis, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended to be used with bone cement.

The tibial component consists of ArCom®, ultrahigh molecular weight polyethylene (UHMWPE) bearings in right and left medial/lateral allocations.

The provided document, K042093, is a 510(k) summary for the Biomet Manufacturing, Corp.'s Vanguard M™ Series Unicondylar Tibial Bearings. This document outlines the device description, indications for use, and a summary of non-clinical testing. However, it explicitly states that no clinical testing was provided as a basis for substantial equivalence. Therefore, the information requested regarding acceptance criteria based on clinical studies, sample sizes, expert qualifications, and ground truth establishment for a study cannot be provided from this document.

From the provided document, the following can be extracted related to non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance (for any testing done):

• Sample Size: Not specified for non-clinical testing.
• Data Provenance: Not applicable as no clinical data was used for substantial equivalence. Non-clinical testing was performed in a laboratory setting by the manufacturer.

3. Number of Experts and Qualifications (for establishing ground truth):

• Not applicable. No clinical study with expert ground truth establishment was conducted or submitted for substantial equivalence.

4. Adjudication Method:

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was mentioned or performed.

6. Standalone (Algorithm Only) Performance Study:

• Not applicable as this is a medical device (tibial bearing) and not an algorithmic/AI device.

7. Type of Ground Truth Used:

• Not applicable as no clinical study or ground truth establishment based on clinical data was performed. For non-clinical testing, the "ground truth" would be engineering specifications and functional benchmarks.

8. Sample Size for the Training Set:

• Not applicable as no clinical study or AI algorithm requiring a training set was performed.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

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