(25 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the elbow that can be interpreted by a trained physician.
Model EXS-63-INT Small Extremity Array Coil
I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a specific MRI coil (Model EXS-63-INT Small Extremity Array Coil), indicating it is substantially equivalent to a predicate device.
The letter discusses regulatory classifications, general controls, and compliance requirements but does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set information).
The core of this document is the FDA's determination of substantial equivalence, which is a regulatory pathway and not a detailed performance study as you described.
§ 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.