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Intended Use

Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease.

Technology

Cleerly ISCHEMIA is an add-on software module to Cleerly Labs that calculates vessel-specific likely ischemia presence based on quantitative measures of atherosclerosis, stenosis, and vascular morphology from typically acquired Coronary Computed Tomography Angiography images (CCTA). It outputs a binary Cleerly ISCHEMIA Index (likely ischemia presence vs absence) equivalent to invasive FFR ≤0.80 vs >0.80. It uses a locked machine learning algorithm and includes preprocessing and postprocessing to assess vessels.

Performance

Performance testing included software verification, risk assessment, and cybersecurity evaluation. Clinical validation was done using data from the CREDENCE trial and other studies involving 582 subjects across multiple centers. Sensitivity was approximately 76% and specificity about 85% at the per-vessel level. The device demonstrated acceptable clinical performance compared to invasive fractional flow reserve (FFR) measurements as the reference standard.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/8/2023

    4 months
  • 2

    FDA Approval

    9/8/2023

Other devices from Cleerly, Inc

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