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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

Model HRK-63 Knee Array Coil

This document is a 510(k) premarket notification letter for the Model HRK-63 Knee Array Coil. It confirms that the device has been reviewed by the FDA and determined to be substantially equivalent to legally marketed predicate devices.

The information provided does not contain the details you are asking for regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This is a regulatory approval document, not a scientific study report.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not included.
2. Sample size used for the test set and the data provenance: Not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not included.
4. Adjudication method for the test set: Not included.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware device (MRI coil), not an AI algorithm.
7. The type of ground truth used: Not included.
8. The sample size for the training set: Not applicable, as this is a hardware device.
9. How the ground truth for the training set was established: Not applicable, as this is a hardware device.

The document only states the device's name, regulation number, regulatory class, product code, and its intended use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician." The FDA's substantial equivalence determination implies that performance characteristics relevant to safety and effectiveness were considered comparable to predicate devices, but the specific studies and their results are not detailed in this letter.

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