(16 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 NVA-63-8 Neurovascular Array Coil
This document is an FDA 510(k) clearance letter for a medical device called the "NVA-63-8 Neurovascular Array Coil." It primarily focuses on the regulatory aspects of the device and confirms its substantial equivalence to a predicate device.
Crucially, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a study (like sample sizes, ground truth establishment, or expert qualifications).
The letter states the "Indications for use:" are: "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." This is a general statement about its intended function, not performance metrics.
Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval, not a scientific study report.
To answer your request, I would need a different document, such as a summary of safety and effectiveness data (SSED) that would have been part of the original 510(k) submission, or a published study related to the device's performance.
§ 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.