(144 days)
The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips. The MRgFUS Coil is designed for use with the GE 1.5 T MRI systems manufactured by GE Medical Systems. The Pelvic Phase Array Coil can be used in conjunction with the InSightec Focused UltraSound (MRgFUS) treatment.
The MRgFUS Phase Array Pelvic Coil (the MRgFUS PA Coil) is a receive only RF coil, designed for MR imaging of the pelvis and hips.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (MRgFUS PA Pelvic Coil), indicating that it has been found substantially equivalent to legally marketed predicate devices.
The letter mentions:
- Device Name: MRgFUS PA Pelvic Coil
- Regulation Number: 21 CFR 892.1000
- Regulation Name: Magnetic resonance diagnostic device
- Regulatory Class: II
- Product Code: MOS
- Indications for Use: The MRgFUS PA Pelvic Coil is a receive-only RF coil, designed for MR imaging of the pelvis and hips. It is designed for use with GE 1.5 T MRI systems manufactured by GE Medical Systems and can be used in conjunction with the InSightec Focused Ultrasound (MRgFUS) treatment.
However, there is no data or description of any studies that would allow me to answer your specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement in a study. The letter is an administrative notification of clearance, not a summary of a performance or clinical study.
§ 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.