QyScore Software is an automated medical image processing software that analyzes brain MRI scans to segment and measure brain structures and lesions. It generates an electronic report and overlays segmentations on images, helping clinicians quantify brain volumes compared to a healthy reference population. This assists in assessment and monitoring of brain health in patients aged 20 to 90 years.
Intended Use
QyScore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data may be compared to reference percentile data. QyScore is not intended for use in clinical scenarios that require evaluation of the number of the white matter hyperintensities.
Technology
QyScore retrieves DICOM MRI data (3DT1 and T2FLAIR), sends it to an analysis server for automatic segmentation using a dynamic probabilistic neuroanatomical atlas. It segments grey matter, white matter, hippocampus, amygdala, and white matter hyperintensities and provides an electronic report with color overlays on images. The software operates on off-the-shelf hardware and integrates with RIS/PACS.
Performance
Performance testing included software verification, validation, human factors testing, and segmentation accuracy versus expert manual labels. Dice coefficients exceeded 85% for whole brain regions and 75-85% for subcortical structures. Lesion segmentation evaluation showed a mean absolute volume difference of 3.34mL. Results confirmed the software meets intended use and user needs.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2019
2 months - 2
FDA Approval
12/13/2019
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