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

Models HRW-63-8 and HRW-127-8 Wrist Array Coils

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for MRI Devices Corporation's Models HRW-63-8 and HRW-127-8 Wrist Array Coils, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document mentions:

• Trade/Device Name: Models HRW-63-8 and HRW-127-8 Wrist Array Coils
• Regulation Number: 21 CFR 892.1000
• Regulation Name: Magnetic resonance diagnostic device
• Regulatory Class: II
• Product Code: MOS

It also includes the Indications for use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician."

However, there is no discussion of any performance acceptance criteria, test methodology, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of detailed study information is typically found in the supporting documentation submitted for 510(k) clearance, not in the clearance letter itself.

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