syngo.CT LVO Detection
Siemens Medical Solutions USA, Inc.syngo.CT LVO Detection is an AI-powered post-processing software that analyzes CT angiography images of the brain to help clinicians prioritize cases by detecting suspected large vessel occlusions in specific brain vessels. It aids in triage but is not used for standalone diagnosis or altering images, thereby assisting medical professionals in managing stroke patients more efficiently.
Intended Use
syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images, supporting computer-aided triage by identifying suspected large vessel occlusions (LVO) in ICA, M1, and M2 segments in patients 22 years or older without certain contraindications. The output is for informational purposes and not intended for diagnostic use or image alteration.
Technology
syngo.CT LVO Detection utilizes artificial intelligence learning algorithms to analyze CT-angiography images of the head. It detects large vessel occlusions in the ICA, M1, and M2 segments and supports triage prioritization by notifying users of suspected LVOs without highlighting specific image areas. The software runs on the syngo.via platform and does not alter original images.
Performance
Performance testing included standalone testing on 602 retrospective CT datasets from multiple US clinical sites, with ground truth established by independent neuroradiologists. The device demonstrated a sensitivity of 90.6% and specificity of 88.8% for LVO detection, surpassing predefined acceptance criteria. Testing covered diverse patient demographics, multiple CT manufacturers, and processing time was under 110 seconds (median 42 seconds). Risk analysis and software validation supported substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/30/2024
6 months - 2
FDA Approval
4/10/2025
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