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Intended Use

ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. It calculates percent breast density as the ratio of fibroglandular tissue to total breast area and provides breast density group information (BI-RADS A+B as fatty and BI-RADS C+D as dense) to aid interpreting physicians in assessing breast tissue composition. It produces adjunctive information and is not a diagnostic aid.

Technology

ClariSIGMAM is a standalone software that automatically analyzes 2D full field digital mammograms for breast tissue composition. It outputs breast density metrics and BI-RADS classification to mammography workstations or PACS via DICOM structured reporting or secondary capture. The software uses image processing to calculate breast and fibroglandular tissue areas and percent density.

Performance

Non-clinical performance testing demonstrated that ClariSIGMAM meets FDA-recognized standards including ISO 14971 and DICOM standards. Validation included comparison to expert radiologist assessments using a gold standard interactive thresholding software, reproducibility across data sets and time points, and comparison of left and right breast density estimates. The results showed good agreement with expert consensus (Kappa 0.734) and high accuracy (~87%). Clinical studies were not required to demonstrate equivalence.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/28/2020

    8 months
  • 2

    FDA Approval

    9/10/2021

Other devices from ClariPi Inc.

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