Oncospace
Oncospace, Inc.Oncospace is a software tool that assists radiation oncologists and medical dosimetrists in planning radiotherapy treatments for patients with cancer in the prostate, head, and neck regions. It uses locked machine learning algorithms to predict achievable dose objectives for organs at risk based on the patient's anatomy and automates aspects of treatment plan optimization. This helps clinicians customize treatment protocols, optimize radiation dose delivery while sparing healthy tissue, and review treatment plans efficiently, ultimately supporting better patient care in radiation oncology.
Intended Use
Oncospace is used to configure and review radiotherapy treatment plans for patients with malignant or benign disease in the prostate, head, and neck regions. It allows setup of treatment protocols, dose prescriptions, achievable dosimetric goals, and review of the treatment plan, intended for use by trained radiation therapy professionals.
Technology
Oncospace is a software-only medical device that augments radiation therapy treatment planning by allowing customization of treatment protocols, predicting dosimetric goals for organs at risk based on patient-specific anatomy using locked machine learning models, automating initiation of plan optimization on treatment planning systems, and providing an interface for plan evaluation. It operates as a client-server platform and is DICOM-RT compliant but does not control radiation delivery devices.
Performance
Verification and validation testing included retrospective clinical data from prostate and head and neck cancer treatment plans. Results showed Oncospace achieved non-inferiority in organ-at-risk dose sparing compared to traditional planning with some statistically significant improvements. The system reduced plan optimization iterations by 77%, indicating increased planning efficiency. All tests confirmed safety and effectiveness compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2022
4 months - 2
FDA Approval
2/2/2023
Other devices from Oncospace, Inc.
- Oncospace2021 • 510K
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