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The coil is indicated for use, on the order of a physician, in conjunction with an MR scanner as an accessory to produce images of the anatomy of interest, as an aid to diagnosis / treatment.

Models HRB-127-32 High Resolution Brain Coil

This document is a 510(k) clearance letter from the FDA for a medical device called "Models HRB-127-32 High Resolution Brain Coil." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the detailed information requested regarding acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information from the given text.

The provided text does NOT contain the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval notice, not a technical performance report.

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