(30 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Model HRK-63-8 Knee Array Coil
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for an MRI knee array coil (HRK-63-8), indicating that it has been determined to be substantially equivalent to legally marketed predicate devices.
The letter mentions:
- Device Name: HRK-63-8 Knee Array Coil
- Regulation Number: 21 CFR 892.1000
- Regulation Name: RF Coil for Magnetic Resonance Imaging System
- Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician."
However, it does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about a study conducted to demonstrate performance, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details about training sets or how ground truth for training was established.
This document is primarily concerned with regulatory clearance based on substantial equivalence, not a detailed technical performance study with specific acceptance criteria.
§ 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.