(50 days)
The intended use of the Noras OR Head Coil 3T 7230-PH is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 3T Philips Achieva Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Moras MRI Products GmbH for their Noras OR Head Coil 3T. This document is a regulatory approval letter and does not contain the results of a study or detailed acceptance criteria for a device.
Therefore, I cannot extract the information required by your request about acceptance criteria and the study proving the device meets them, because this information is not present in the provided text.
The document states that the FDA reviewed the 510(k) premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies on demonstrating equivalence to an already approved device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a Premarket Approval (PMA) application might.
The indications for use are provided, but these are not the acceptance criteria or device performance data.
§ 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.