(63 days)
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
The nordicBrainEx is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application.
- . BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
- . DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain.
- . DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage.
- DCE Perfusion analysis: Enables analysis of Dynamic Contrast Enhancement (DCE) MR data. In contrast to DSC Perfusion which uses T2* weighted sequence, DCE Perfusion uses T1-weighted sequence to measure bolus passage. Parameters are calculated to provide information about blood vessel structure and characteristics. The output maps from these calculations include interstitial volume (Ve), plasma volume (Vp), transfer constant map (Ktras), rate constant map (Kep), area under the curve (AUC), time to peak (TTP), peak, wash In and wash Out.
In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.
The provided text does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets acceptance criteria in the format requested.
The document is a 510(k) premarket notification letter and summary for the nordicBrainEx device, indicating its substantial equivalence to a predicate device (nordicICE). While it mentions "extensive in-house testing" and "prospectively defined verification and validation activities" to assure the device meets design and performance specifications, it does not provide the quantitative results or the methodology of these tests in detail.
Therefore, I cannot extract the information required for the table and bullet points provided in your request. The document explicitly states that the "successful completion of said tests verifies the claimed characteristics of nordicBrainEx, and thus supports the determination of substantial equivalence," but it does not present the 'acceptance criteria' or the 'reported device performance' in a measurable way that can be tabulated.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).