(18 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.
Model HRW Wrist Array Coil
The provided documents (Images {0} and {1}) are a 510(k) clearance letter from the FDA and the corresponding Statement of Indications for Use for the MRI Devices Corporation's Model HRW Wrist Array Coil. These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. The FDA's 510(k) pathway often relies on demonstrating substantial equivalence rather than requiring extensive clinical trials with acceptance criteria and detailed performance metrics as might be seen for novel, high-risk devices.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details because it is not present in the provided text.
§ 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.