(56 days)
BrainStat is an automated post-processing software option that is designed to process a time-series of MR images acquired in the brain. BrainStat is indicated for use on dynamic magnetic resonance imaging data sets to depict parametric images that are calculated from the image intensity variations over time. These parametric images include the integrated-area of the signal intensity change, the time from the beginning of the change of intensity to the end of the intensity change, and the ratio of the integrated area to the time.
BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis.
The BrainStat Software Option is a software application to be used on GE Signa MR scanners. It is an evolutionary improvement to the post-processing application known as FuncTool on the HDx 1.5T and 3.0T MRI scanners (K052293).
The provided text does not contain information about acceptance criteria or specific study details proving that the device meets those criteria. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than detailing performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the questions regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states: "This premarket notification submission demonstrates that the BrainStat software option is substantially equivalent to an analogous feature in Esaote's Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera because it has the same intended use and functionality." This indicates that the primary "study" or justification for clearance was a comparison of intended use and functionality to a predicate device, rather than a separate performance study with defined acceptance criteria.
§ 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.