(11 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce 16 be abod in confully that can be interpreted by a trained physician.
Model HAC-420 Head Array Coil
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Magnetic Resonance Imaging System, specifically the HAC-420 Head Array Coil.
This letter primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and general information but does not contain detailed performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be necessary to answer the questions posed.
The only performance-related statement is in the "Indications for Use" section, which says: "To be used in conjunction with a Magnetic Resonance Scanner to produce [text is cut off, but likely refers to images] that can be interpreted by a trained physician." This is an intended use statement, not a performance metric or acceptance criterion.
§ 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.