(10 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 KFA-12 Knee, Foot, and Ankle Array Coil
The provided text is a 510(k) premarket notification letter from the FDA regarding an MRI coil (Model KFA-12 Knee, Foot, and Ankle Array Coil). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as it would for an AI/CADe device.
Instead, this letter confirms the device's substantial equivalence to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. The core of a 510(k) for this type of device (an MRI coil) typically focuses on demonstrating that the new device has the same intended use and performance characteristics as a legally marketed predicate device, without raising new questions of safety and effectiveness.
Therefore, I cannot extract the information required in your request about acceptance criteria and study details from the provided text because it primarily concerns regulatory approval for a medical device (an MRI coil), not an AI/CADe software that would have performance metrics like sensitivity, specificity, or reader study results.
§ 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.