Intended Use

Oncospace is used to configure and review radiotherapy treatment plans for patients with malignant or benign disease in prostate, thoracic, pancreas, or head & neck regions. It allows setting treatment protocols, associating treatment plans, submitting dose prescriptions and dosimetric goals to treatment planning systems, and reviewing treatment plans. Intended for use by qualified radiation therapy professionals.

Technology

Oncospace is a software-only device employing locked machine learning algorithms to augment radiotherapy treatment planning by predicting individualized dosimetric goals for organs at risk based on patient-specific anatomical geometry. It integrates with existing treatment planning systems via DICOM to automate plan optimization and review, without controlling radiation delivery devices or modifying ROI contours.

Performance

Verification and validation testing showed the device met system requirements and improved planning efficiency by reducing the number of plan optimization iterations by almost two thirds compared to traditional workflows, based on retrospective clinical data across prostate, thoracic, pancreas, and head & neck cancers. Safety and effectiveness were demonstrated without adverse effects.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/12/2020

    7 months
  • 2

    FDA Approval

    3/12/2021

Other devices from Oncospace, Inc.

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