(73 days)
Quantib™ Brain is a non-invasive medical imaging processing application that is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures from a set of magnetic resonance (MR) images. The Quantib™ Brain output consists of segmentations, visualizations and volumetric measurements of grey matter (GM), white matter (WM), and cerebrospinal fluid (CSF). The output also visualizes and quantifies white matter hyperintensity (WMH) candidates. Users need to review and if necessary, edit WMH candidates using the provided tools, before validation of the WMHs. It is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the trained medical professional in quantitative reporting. Quantib™ Brain is a post-processing plugin for the GE Advantage Workstation (AW 4.7) or AW Server (AWS 3.2) platforms.
Quantib™ Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 13.0 Ext 4 (or higher). It is intended for automatic labeling, visualization, and volumetric quantification of identifiable brain structures from magnetic resonance images (a 3D T1-weighted MR image, with an additional T2-weighted FLAIR MR image for white matter hyperintensities (WMH) segmentation). The segmentation system relies on a number of atlases each consisting of a 3D T1-weighted MR image and a label map dividing the MR image into different tissue segments. Quantib™ Brain provides quantitative information on both the absolute and relative volume of the segmented regions. The automatic WMH segmentation is to be reviewed and if necessary, edited by the user before validation of the segmentation, after which volumetric information is accessible. Longitudinal analysis can be performed for the brain tissue segmentation and WMH seqmentation in order to compare multiple exams of an individual patient. Quantib Brain is intended to provide the trained medical professional with complementary information for the evaluation and assessment of MR brain images and to aid the radiology specialist in quantitative reporting.
Here's an analysis of the acceptance criteria and study details for QuantibTM Brain 1.3 based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from Study) | Reported Device Performance |
|---|---|
| Brain Volumetry (GM, WM, CSF): | |
| Dice index closer to 1 (perfect overlap) | CSF: 0.78 ± 0.05 |
| GM: 0.84 ± 0.02 | |
| WM: 0.86 ± 0.02 | |
| Absolute difference of relative volumes | CSF: 1.8 ± 1.0 pp |
| (lower is better, implied target |
§ 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).