(15 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Not Found
This is a 510(k) premarket notification letter from the FDA regarding MRI coils, not a study report or clinical trial. Therefore, the provided text does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document is an FDA clearance letter, indicating that the device (HRK-63-8 PMS and HRK-127-8 Knee Array Coils) has been deemed substantially equivalent to a legally marketed predicate device. This process does not typically involve the detailed performance studies with acceptance criteria, ground truth, and expert adjudication that would be present in a clinical trial report.
Therefore, I cannot populate the table or answer the specific questions based on 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.