(45 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-127-8 Neurovascular Array Coil
The provided text is an FDA 510(k) clearance letter for a medical device (MRI Neurovascular Array Coil). It does not contain any information about acceptance criteria, study design, or device performance metrics.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the input provided. The letter simply states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.
To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, which would detail the performance data and the methods used to collect it.
§ 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.