(53 days)
mStar MPF4500 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 (Tl), spin-spin relaxation time (E), and flow.
mStar MPF4500 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 (Tl), spin-spin relaxation time (E), and flow.
I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a Magnetic Resonance Diagnostic Device (MPF4500), indicating substantial equivalence to a predicate device.
The letter mentions:
- Device Name: MPF4500
- Regulation Number: 21 CFR 892.1000
- Regulation Name: Magnetic resonance diagnostic device
- Regulatory Class: II
- Product Code: MOS
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
- If a standalone algorithm performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval, not a technical report detailing the performance studies conducted. To provide the requested information, a different type of document, such as a summary of safety and effectiveness, clinical study report, or a more detailed submission document, would be required.
§ 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.