(72 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the pediatric head and spine, that can be interpreted by a trained physician.
Model PHSL-63 Pediatric Head and Spine Array Coil
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the Model PHSL-63 Pediatric Head and Spine Array Coil. This letter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also outlines regulatory requirements and contact information.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design based on the input provided.
§ 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.