(9 days)
Open Magnetic Resonance Imaging System, MPF3000-III is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal and oblique images that display the internal structure of the head, body or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (E) and flow.
Open Magnetic Resonance Imaging System, MPF3000-III is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Ciient PC, and Imaging Cabinet. The system software, PROSPECT, based on Windows XP® Professional is aninteractive program with user friendly interface.
This document is a 510(k) Summary for the XinAo MDT Open Magnetic Resonance Imaging System, MPF3000-III. It details the device's technical specifications and claims substantial equivalence to a predicate device. However, it does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria.
The document discusses:
- The device (MPF3000-III) is a 0.3T permanent magnet MRI system.
- Its intended use is to provide physiological and clinical information by producing images of the internal structure of the head, body, or extremities.
- "Performance testing was conducted to validate and verify that the proposed device...met all design specifications and was substantially equivalent to the predicate device."
- The device complies with several IEC and NEMA standards.
- The conclusion is that the device is "Substantially Equivalent (SE)" to the predicate device, mStar MPF4500 (K073457).
Therefore, based on the provided text, I cannot extract the requested information. The filing states performance testing was done to meet design specifications and demonstrate substantial equivalence, but it does not detail the specific acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy), the results of such a study, sample sizes, expert qualifications, or ground truth methods.
§ 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.