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Intended Use

AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. It analyzes cases using an artificial intelligence algorithm to identify suspected findings and makes case-level output available to a PACS/workstation for worklist prioritization or triage.

Technology

The device is a DICOM-compliant AI software installed in radiology networks that uses deep learning to identify suspected acute intracranial hemorrhage from non-contrast head CT images. It performs skull stripping, tissue segmentation, feature identification including hyperdensity thresholds, and generates a case-level probability to prioritize cases. It works parallel to standard workflows and outputs to PACS or workstations for clinical review prioritization.

Performance

The device was tested in a retrospective clinical study analyzing 360 head CT cases from multiple US sites. It achieved high sensitivity (97%) and specificity (93%) for detecting acute intracranial hemorrhage, with a faster average processing time of 1.17 minutes per case compared to predicate device. Sensitivity for intra-axial hemorrhages was 100%, for extra-axial 92%. Negative predictive value was 99.8%. These results support its safety and effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/15/2020

    2 months
  • 2

    FDA Approval

    8/7/2020

Other devices from MaxQ Al Ltd.

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