Search Results

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

Not Found

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "HRH-63-8 Head Array Coil." It states that the device is substantially equivalent to legally marketed predicate devices and is intended to "produce diagnostic images of the head, that can be interpreted by a trained physician."

However, the document does NOT contain information about:

1. Acceptance criteria and reported device performance: These details are typically found in the 510(k) submission summary, not the clearance letter.
2. Sample size for the test set and data provenance: Not mentioned.
3. Number of experts and their qualifications for ground truth: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone (algorithm-only) performance: Not applicable as this is a hardware device (coil).
7. Type of ground truth used: Not applicable as this is a hardware device.
8. Sample size for the training set: Not applicable as this is a hardware device.
9. How ground truth for the training set was established: Not applicable as this is a hardware device.

The FDA clearance letter primarily confirms that the device is legally cleared for marketing based on substantial equivalence, not a detailed performance study with specific metrics and methodologies as requested.

Ask a specific question about this device