(20 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.
Model HNC-63-INT Neurovascular Array Coil
The provided text is a 510(k) premarket notification approval letter for the Model HNC-63-INT Neurovascular Array Coil, issued by the FDA in 2001. This document indicates the device's approval based on substantial equivalence to existing devices, but it does not contain details about specific acceptance criteria or a study proving the device meets them.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of detailed performance studies and their results are typically found in the supporting technical documentation submitted with the 510(k), not in the approval letter itself.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This means the device was found to be as safe and effective as a device already on the market, not necessarily that a specific performance study with acceptance criteria was conducted and detailed in this letter.
§ 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.