Intended Use

Ethos Treatment Management is indicated for use in managing and monitoring radiation therapy treatment plans and sessions; Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans.

Technology

Ethos Treatment Management provides tools for managing treatment plans including AI segmentation deep learning algorithms for contouring, support for hypersight images and high fidelity mode; Ethos Treatment Planning includes enhanced optimizer engines, AI segmentation with additional anatomical site support and direct CBCT dose calculation support.

Performance

The software underwent formal design verification and validation demonstrating performance as intended. AI segmentation models were validated using DICE metrics and evaluated by clinical experts confirming contours required minor or no adjustments in 80% of cases. No clinical trials were included; testing was limited to software verification and validation.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/19/2023

    7 months
  • 2

    FDA Approval

    4/30/2024

Other devices from Varian Medical Systems Inc.

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