(42 days)
nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
nordicBrainEx provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.
DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.
The nordicBrainEx·Software is a post-processing application for functional MRI data developed with a view to ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for processing and analyzing BOLD fMRI and DTI data, in addition to efficient and easy to use tools for visualization and report generation. The application workflow has been optimized to ensure efficiency and high throughput in a clinical environment.
The provided text does not contain detailed information about specific acceptance criteria, reported device performance metrics, or a study that uses a test set, ground truth, or expert review for the nordicBrainEx Software. The documentation focuses on establishing substantial equivalence to a predicate device (nordicICE Software, K090546) through general "verification and validation activities" rather than presenting a performance study with quantitative results against specific criteria.
Therefore, many of the requested fields cannot be filled.
Here's a summary of what information is available in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific device performance metrics in the way you've requested (e.g., sensitivity, specificity, accuracy). It broadly states that "Prospectively defined verification and validation activities for the nordicBrainEx Software assure that the nordicBrainEx Software is substantially equivalent to the cleared nordicICE Software and meets design and performance specifications as well as user needs when operated according to the operating instructions." This implies that the acceptance criteria revolved around demonstrating functional equivalence to the predicate device and meeting internal design specifications and user needs.
2. Sample size used for the test set and the data provenance
Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided text.
4. Adjudication method for the test set
Not specified in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No MRMC study is mentioned. The focus is on substantial equivalence to a predicate device, not on improving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the software as a "post-processing application" and "image processing software package to be used by trained professionals including but not limited to physicians and medical technicians." This indicates it's designed to be used by humans, implying human-in-the-loop. No standalone algorithm performance is detailed.
7. The type of ground truth used
Not specified in the provided text.
8. The sample size for the training set
Not specified in the provided text. The document refers to "verification and validation activities" but doesn't detail specific training sets.
9. How the ground truth for the training set was established
Not specified in the provided text.
§ 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).