(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician.
Models CTL-63 and CTL-128 Spine Array Coils
This document is an FDA 510(k) clearance letter for two spine array coils (Models CTL-63 and CTL-128). It primarily addresses the regulatory approval process and states that the devices are substantially equivalent to legally marketed predicate devices.
Crucially, this document does NOT contain a study that proves the device meets acceptance criteria, nor does it provide any of the detailed information requested in your prompt regarding performance metrics, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).
The letter confirms that the devices are intended "to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cervical, lumbar, and thoracic regions of the spine that can be interpreted by a trained physician." However, it does not specify what "diagnostic images" means in terms of image quality metrics, clinical accuracy, or any performance benchmarks.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, which may involve engineering comparisons and basic bench testing rather than extensive clinical efficacy studies with the type of detailed performance criteria you are asking for.
To answer your questions, you would need access to the actual 510(k) submission itself (which is not provided here) or a separate clinical study report for these devices.
§ 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.