(29 days)
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.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.