(30 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-63-INT Wrist Array Coil
The provided text is an FDA 510(k) clearance letter for an MRI coil, not a study report for an AI/ML device. Therefore, it does not contain the information required to populate the requested tables and answer the questions about acceptance criteria, study design, and performance for an AI/ML device.
The document states that the "Model HRW-63-INT Wrist Array Coil" is "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." This is a description of the device's intended use, not performance criteria.
Without a detailed study report describing the evaluation of an AI/ML device, it's impossible to provide the requested information.
§ 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.