(18 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician.
Model Osh-085 Wrist Array Coil
The provided text is a cover letter from the FDA to MRI Devices Corporation regarding their 510(k) notification for the Model Osh-085 Wrist Array Coil. It also includes the "Indications for Use" statement for the device.
This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions you've asked, as the input document does not contain that level of detail about a study.
The primary information available is:
- Device Name: Model Osh-085 Wrist Array Coil
- Intended Use: To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand, that can be interpreted by a trained physician.
- Regulatory Class: II
- Procode: 90 MOS
- Date: October 15, 1999
To answer your request thoroughly, you would need to provide a document that describes the design verification and validation studies performed for this device, which would typically be found in the 510(k) summary or full submission.
§ 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.