Rapid ASPECTS (v3)
iSchemaView, Inc.Rapid ASPECTS (v3) is a software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. It automatically analyzes certain brain regions to generate an ASPECT Score, which helps characterize ischemic damage. This tool supports radiologists by providing standardized, AI-derived scores and annotated images, facilitating accurate and consistent stroke assessment to inform treatment decisions.
Intended Use
Rapid ASPECTS is a computer-aided diagnosis software device used to assist clinicians in assessing and characterizing brain tissue abnormalities using CT image data, generating an ASPECT score for ischemic stroke patients typically within 24 hours of last known well.
Technology
Rapid ASPECTS uses machine learning (random forest technique) to automatically register, segment, and analyze pre-defined brain regions on non-contrast CT images, extracting morphological imaging features that are combined into a single ASPECT score to aid clinical interpretation.
Performance
Performance validation included standalone and integrated software testing showing 82.8% agreement with reference standards at regional and scan levels, clinical reader studies demonstrated improved accuracy with Rapid ASPECTS assistance, and sensitivity assessments showed minimal confounder impact, supporting device safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/20/2023
6 months - 2
FDA Approval
1/19/2024
Other devices from iSchemaView, Inc.
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 510K
- Rapid Aneurysm Triage and Notification2023 • 510K
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