(80 days)
The Signa SP Flexible Coll family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.
The Signa SP Flex Colls are a group of symmetric transmit/receive surface colls of varying dimensions that are coupled as helmholtz pairs and contained in a flexible, biocompatible outer covering.
I am sorry, but the provided text is a 510(k) summary for a medical device (Signa SP Flex Coils) from 1997. It describes the device, its intended use, and its substantial equivalence to a predicate device.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot extract the requested information from the given input. The information you are asking for typically comes from a detailed clinical study report, which is not present here.
§ 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.