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Intended Use

PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized 2D images from tomosynthesis exams. It provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in assessing breast tissue composition. It produces adjunctive information and is not a diagnostic aid.

Technology

PowerLook Density Assessment V4.0 is a software application designed to run on the PowerLook AMP platform, utilizing data management capabilities of the PowerLook AMP for controlling input and output. It processes synthetic 2D images generated from digital breast tomosynthesis data. The software supports multiple DBT systems including Hologic and GE models. The V4.0 version includes a new custom software application independent from previous versions and validated to support GE V-Preview V4.1 data.

Performance

Verification included unit, integration, and regression testing. Performance tests were conducted using datasets from Hologic C-View, GE V-Preview V3, and V4.1. Confusion matrices demonstrated desired or better performance for breast density classification accuracy according to BI-RADS.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    5/14/2021

    1 month
  • 2

    FDA Approval

    7/12/2021

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