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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Specific indications for various components and systems are also listed.

The purpose of this submission is the addition of MR Conditional labeling to the Instructions for Use for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are intended for use in knee arthroplasty.

The provided text is related to the Zimmer Knee Joint Replacement Prostheses MR Labeling and details its indications for use and a summary of performance data related to MR Conditional labeling. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond MR Conditional labeling.

The document states:

• The purpose of the submission is the addition of MR Conditional labeling to the Instructions for Use for predicate devices.
• The addition of MR labeling does not impact indications, materials, design features or dimensions, packaging or sterilization.
• Clinical data was not provided for the subject devices.
• Non-clinical tests were performed to establish the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment.

Therefore, I cannot fulfill all parts of your request as the provided text lacks the detailed information regarding a broad set of acceptance criteria and a study proving the device meets them beyond MR safety.

However, I can extract information related to the MR Conditional testing.

Information on MR Conditional Testing (the only "performance data" provided):

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size for the test set and data provenance:

• Sample Size: Not specified for the MR tests. The testing refers to "implants," implying samples of the knee joint replacement prostheses.
• Data Provenance: Not explicitly stated, but the tests refer to ASTM standards, which are international standards for materials testing. The testing was performed by "Zimmer." The overall submission is for regulatory clearance in the United States (FDA). The study is retrospective as it refers to testing already performed to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not applicable. For these non-clinical engineering-based MR safety tests, "ground truth" is established by adherence to the specified ASTM test method standards and the physical properties of the materials, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation (e.g., image reading). These non-clinical tests rely on instrumental measurements and adherence to standard protocols.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document explicitly states "Clinical data was not provided for the subject devices." These are non-clinical hardware tests for MR compatibility.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical knee prosthesis, not an algorithm. The MR conditional tests evaluate the physical interaction of the device with an MR environment.

7. The type of ground truth used:

• The "ground truth" for these specific MR tests is defined by the physical measurement criteria and thresholds stipulated in the cited ASTM standards (F2182-11a, F2119-07, F2052-14) for determining "MR Conditional" status, and the standard for nonpyrogenicity. It relates to the inherent material and design properties of the implanted device.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set exists for this type of device.

In summary, the provided document details the indications for use for various Zimmer Knee Joint Replacement Prostheses and the fact that non-clinical tests were conducted to demonstrate MR Conditional safety and compatibility, allowing for appropriate MR labeling. It does not provide performance data or acceptance criteria in the context of clinical efficacy or diagnostic accuracy, as it explicitly states no clinical data was provided.

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