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Intended Use

Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. It provides an automated ASPECT score for patients presenting with known MCA or ICA occlusion to evaluate extent of disease within 6 hours of symptom onset.

Technology

Rapid ASPECTS uses a machine learning algorithm based on a random forest technique that automatically registers, segments, and analyzes non-contrast CT brain images by delineating predefined ASPECTS regions of interest to compute morphological features. It outputs an automated ASPECTS score reflecting early ischemic changes, integrates with PACS, and requires physician confirmation of Large Vessel Occlusion detection.

Performance

Extensive validation including clinical reader studies with expert neuroradiologists and typical users showed Rapid ASPECTS improves accuracy of ASPECTS scoring, especially for non-expert physicians, achieving statistically significant agreement closer to expert level. Software testing, verification, and validation demonstrated accuracy and conformance to relevant standards including ISO 14971, IEC 62304, and DICOM. The system was robust across clinically relevant parameters.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/24/2020

    3 months
  • 2

    FDA Approval

    6/26/2020

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