(39 days)
The MRgFUS General Purpose and Breast Coil (the MRgFUS Coil) is a receive only RF coil, designed for MR imaging of the breast and auxiliary tissue and of a variety of medium sized anatomical regions, such as spine, neck, shoulder, thigh, foot ankle and joints.
The MRgFUS Coil is designed for use with the GE Signa™ (1.5 T or 3.0 T) MRI systems manufactured by GE Medical Systems.
The MRgFUS Coil is a receive only coil. The coil is a single element coil consisting of two 6.5 inch loops located one above the other and connected electrically in parallel. Coupling of the coil to the transmitted field is prevented through three RF blocking circuits, one active and two passive circuits.
There are two versions of the MRgFUS Coil, one compatible with 1.5 T MRI and the other with 3.0T MRI, providing operating frequency of 63.8 MHz and 127.6 MHz, respectively. This difference in the operating frequency dictates different components value (i.e. capacitors and inductors). Another difference is the coil connector, which is dictated by the MRI coil interface. In all other aspects, the two coil versions are identical.
The MRgFUS Coil is specially designed for MR imaging of variety of anatomic regions including the human female breast in conjunction with a Focused UltraSound (FUS) treatment employing MR thermometry to monitor temperature. The coil provides optimum signal to noise ratio and coverage, allowing high-resolution imaging, while the sensitive region of the coil covers approximately a 15 cm Field of View.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (MRgFUS General Purpose and Breast Coil), focusing on its substantial equivalence to predicate devices. It lists performance standards that the device conforms to but does not provide specific acceptance criteria or the results of a study demonstrating the device's performance against those criteria.
Therefore, I cannot generate the requested table or the detailed information about sample sizes, ground truth establishment, or comparative effectiveness studies.
§ 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.