(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder when interpreted by a trained physician.
Model QSC-127-INT Shoulder Array Coil Set
I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (Model QSC-127-INT Shoulder Array Coil Set). It confirms the device's substantial equivalence to predicate devices and outlines regulatory compliance.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval letter, not a technical report or study summary.
Therefore, I cannot extract the requested information from this 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.