(308 days)
The BOLD Analysis option for the EasyVision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.
The BOLD Analysis package supports the visualization and analysis of dynamic MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs over dynamic scans as a result of the variation of blood oxygenation through task performance by the subject (e.g. finger tapping). BOLD data can be processed with the BOLD Analysis package to provide data analysis based on standard statistical methods.
The provided text is a 510(k) Summary for the Philips Easy Vision Family Workstation Option BOLD Analysis Package. It describes the device's intended use and safety information, as well as the FDA's clearance letter. However, this document does not contain any information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device rather than detailed performance 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.