(10 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head, that can be interpreted by a trained physician.
Model HRH-127-8 Head Array Coil for the GE Signa 3T Excite MRI System
The provided document is a 510(k) premarket notification letter from the FDA for an MRI head coil (HRH-127-8 Head Array Coil for GE Signa 3T Excite MRI System). This type of document is an approval for a medical device that demonstrates substantial equivalence to a legally marketed predicate device.
The letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information based on this document. The document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to existing devices for producing diagnostic images of the head. It does not detail the specific performance metrics or studies used to demonstrate this equivalence.
§ 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.