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Intended Use

Software for use by hospitals and clinics to automatically assess the cardiothoracic ratio (CTR) of chest X-ray images in posterior-anterior (PA) view for adults aged 20 to 80 years. It measures the maximal transverse diameter of the heart and thoracic cavity using AI algorithms. Intended users are physicians or licensed practitioners. Results are not for stand-alone clinical decision-making.

Technology

Non-invasive computer-assisted radiological software installed on a computer. It analyzes DICOM chest X-ray images in PA view using AI algorithms to identify and measure the maximal transverse heart diameter and thoracic cavity diameter, then calculates the cardiothoracic ratio. Outputs include annotated images with lines indicating the measurements and CTR records.

Performance

Verification and validation testing of the software demonstrated it meets design requirements and intended use. Accuracy compared to expert panel readings was greater than 95% for identification of imaging mode and view. Annotation models showed low root-mean-square errors for heart and thoracic cavity diameters (~8.81mm and ~14.3mm). Clinical performance testing on 840 adult PA chest X-rays showed 95% accuracy compared to physician-derived cardiothoracic ratios. Non-clinical testing met international standards for software verification, validation, and usability.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/18/2021

    7 months
  • 2

    FDA Approval

    4/4/2022

Other devices from Ever Fortune. AI Co., Ltd.

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