(132 days)
The Miniflex Coil is indicated for use in magnetic resonance imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.
The Miniflex Coil is a receive-only coil designed for use with General Electric Medical System's 1.5T SIGNA MRI Scanner. The coil is designed to give better imaging quality than would be possible with the Body Coil, by maximizing signal reception by closely conforming to the specific body part to be imaged. The physical structure of the antenna consists of two figure-eight shaped coils in a flexible, fabric-covered material. This allows the coil to bend, making it easy to wrap around the anatomy of interest. The coil is fastened to the patient with flexible straps. All patient-contact materials are biocompatible and were chosen to maximize patient comfort. User instructions are contained in the User Manual provided with each device.
I'm sorry, but the provided text describes a medical device (Miniflex Coil) and its technological characteristics and intended use. It does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed metrics related to a study (sample size, data provenance, ground truth, expert qualifications, etc.).
The document seems to be a premarket notification summary (510(k) submission) from 1996 for an MRI accessory, focusing on demonstrating substantial equivalence to predicate devices rather than presenting performance study results against predefined acceptance criteria. The only mention of "Imaging Quality" is a subjective statement: "Good to Excellent, compared to predicate devices," with "N/A" for the predicate devices, indicating this is not a quantified performance measure from a study.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.