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

Models HRS-63-8 and HRS-127-8 Shoulder Array Coils

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (MRI coils). This type of document does not contain information regarding software-related acceptance criteria, study details, or AI performance metrics.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory classifications, general controls, and compliance requirements for the physical device, but it does not include any performance data or studies that would address the points in your request related to acceptance criteria for software, AI, or human reader performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts for ground truth, or adjudication methods for a test set.
3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Type of ground truth used.
5. Sample size for the training set or how its ground truth was established.

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