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Intended Use

Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems. The software marks regions of soft tissue lesions and calcifications with an abnormality score indicating likelihood of malignancy, and is intended for use with screening mammograms of the female population. It is not a replacement for a physician's full clinical review or judgment.

Technology

Lunit INSIGHT DBT is a computer-assisted detection/diagnosis software powered by AI and deep learning technology that automatically analyzes digital breast tomosynthesis slices. It generates analysis results including lesion type, location, lesion-level and case-level scores, and outlines suspected regions to augment physician workflow in diagnosis.

Performance

Performance testing included software verification and validation, standalone performance testing on 2,202 DBT exams from multiple US imaging facilities, and a clinical multi-reader multi-case (MRMC) study with 15 qualified radiologists evaluating interpretation performance with and without the device. The standalone study showed high accuracy with AUROC of 0.928 exceeding the predicate device, and the clinical study demonstrated statistically significant performance improvement with CAD assistance compared to without (AUROC 0.915 vs 0.897, p=0.0498).

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/22/2023

    5 months
  • 2

    FDA Approval

    11/6/2023

Other devices from Lunit Inc.

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