(9 days)
The coil is intended to be used in conjunction with a PHILIPS 1.5T MRI scanner as an accessory to produce images of the wrist, hand and elbow.
The Wrist Hand Coil 1.5T 4ch is a 4-channel phased array, receive-only coil, used for obtaining diagnostic images of wrist, hand and elbow in magnetic resonance imaging systems. These images, when interpreted by a trained physician, yields information that may assist in diagnosis. The elements and associated circuitry of the coil are enclosed in a rigid fire rated housing. The sensitive region of the coil offers an approximate 220x117x83 mm3 field of view. With two opening in the coil, patients can bend their wrists at different angles in scanning process.
The provided document is a 510(k) summary for a medical device called the Model CG-WHC18-H150-AP Wrist Hand Coil 1.5T 4ch. This document does not contain information about a study with acceptance criteria for a device with artificial intelligence (AI) or machine learning (ML) components.
This document describes a traditional medical device (an MRI coil) and its substantial equivalence to predicate devices, focusing on technical characteristics, safety, and effectiveness in generating diagnostic images. It does not mention any AI algorithms, human-in-the-loop studies, or specific performance metrics like sensitivity, specificity, or AUC that would be associated with AI evaluations.
Therefore, I cannot fulfill your request for the acceptance criteria and study details as they are explicitly not present in the provided text.
§ 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.