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Intended Use

ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. It uses an AI algorithm to analyze images for features suggestive of pneumothorax 5 mm or larger and provides output for worklist prioritization but is not for diagnostic use beyond notification.

Technology

The device uses machine learning and image processing algorithms to analyze adult digital frontal chest radiographs received via DICOM protocol. It operates in parallel with standard care, provides a case-level output for worklist prioritization, and requires both lungs visible. The software normalizes image characteristics to mitigate device differences and detects local patterns clinically meaningful for pneumothorax identification.

Performance

The device underwent extensive non-clinical testing per FDA Quality System regulations and ISO standards, including software lifecycle and risk management compliance. Clinical performance testing on an independent dataset of over 1000 adult chest X-rays demonstrated high accuracy with an AUC-ROC of 0.974, sensitivity of 0.922, specificity of 0.951, and average notification time of 9.73 seconds, supporting its effectiveness as a triage tool.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/9/2021

    4 months
  • 2

    FDA Approval

    3/10/2022

Other devices from Riverain Technologies, Inc.

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