(23 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee , foot, and ankle that can be interpreted by a trained physician.
Model KAC-300 Knee Array Coil
The provided documents are a 510(k) clearance letter from the FDA for a medical device (Model KAC-300 Knee Array Coil) and its associated Indications for Use statement. These documents do not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications related to the device's diagnostic capabilities.
The 510(k) clearance letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The Indications for Use statement specifies that the coil is "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee, foot, and ankle that can be interpreted by a trained physician."
Therefore, I cannot fulfill your request for information about acceptance criteria and the study proving the device meets them based on the provided input. This type of information would typically be found in a separate clinical study report or performance evaluation report, which is not part of this 510(k) submission summary.
§ 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.