syngo.CT Brain Quantification
Siemens Medical Solutions USA, Inc.syngo.CT Brain Quantification is a software tool designed to help radiologists analyze non-contrast CT scans of the brain. Using artificial intelligence, it automatically identifies and measures abnormal areas of increased density (such as those caused by bleeding) and calculates midline shift, a sign of severe brain injury. This helps clinicians quickly assess and quantify critical findings in adult patients.
Intended Use
syngo.CT Brain Quantification is a radiological post-processing application for the analysis of non-contrast head CT images. The device is intended for automatic labeling, visualization, and quantification of intracranial structures. It is intended for use in the analysis of intracranial hyperdensities and midline shift in patients aged 18 years or above, with no surgical signs present in the images.
Technology
The device is a standalone post-processing software that uses deep learning (supervised voxel classification with convolutional neural networks) to automatically segment and quantify intracranial hyperdensities and midline shift on non-contrast brain CT scans. It interoperates via DICOM, operates on multi-vendor CT input, and outputs annotated DICOM images for clinical review.
Performance
The device underwent extensive non-clinical and clinical performance evaluation, including software verification and validation, algorithm performance, and risk management. Clinical performance was established with retrospective studies: Midline shift accuracy was measured in 300 CT cases (mean absolute difference 0.87 mm), and hyperdensity segmentation accuracy was measured in 200 cases (Dice coefficient 0.72). Results demonstrated that the device met all predefined acceptance criteria and performed comparably to ground-truth measurements by expert neuroradiologists.
Predicate Devices
No predicate devices specified
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