(18 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissue, that can be interpreted by a trained physician.
Model OBC-250-PAN Breast Array Coil
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Model OBC-250-PAN Breast Array Coil". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its similarity to existing cleared devices, not on a new clinical study demonstrating specific performance metrics.
Therefore, I cannot provide a table of acceptance criteria or details about a study that proves the device meets them from the given text.
To reiterate, the document is a regulatory approval notice and does not contain the information requested.
§ 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.