(63 days)
The OrthoVu-1000 is intended to produce MRI images of human extremities, which when reviewed by a qualified medical practitioner, can render medical information of the region under review.
The OrthoVu-1000 is a transportable, permanent-magnet MRI system, which uses a surface magnet/coil assembly to perform nuclear magnetic resonance imaging of human anatomy with particular emphasis on the imaging of extremities. This system utilizes a non-homogeneous magnetic field, developed by a single device head, which applies magnetic and radio frequency (RF) energy and then detects the resultant spin echoes. A computer system controls excitation and performs processing and imaging functions. The control and imaging computer as well as the associated electronics package is mounted on a cart with a magnet assembly which can be manually positioned in the correct orientation to perform the desired imaging.
The provided document is a 510(k) Premarket Notification for the OrthoVu-1000 Magnetic Resonance Imaging System. It describes the device, its intended use, and its technological comparison to predicate devices. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, or details regarding algorithm performance, sample sizes, expert involvement, or ground truth establishment for AI/algorithm-based testing.
The document is purely a regulatory submission for a traditional MRI device, not an AI-powered diagnostic tool. Therefore, none of the requested information regarding acceptance criteria and study details for an AI/algorithm-based device can be extracted from this text.
The document does not provide the information requested in the prompt as it pertains to an MRI system, not an AI-powered device.
§ 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.