📊 Evidence-Based Reference
Radiation Planning Assistant Rpa
University Of Texas, Md Anderson Cancer Center
Summary: The Radiation Planning Assistant (RPA) is a web-based tool designed to automate radiotherapy planning, primarily for clinics with limited resources. Key evidence highlights its potential to improve access to cancer care globally.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222728 ↗
Decision Date ?
May 17, 2023
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Radiation Planning Assistant RPA was cleared by the FDA via the 510(k) pathway on May 17, 2023. It is manufactured by the University Of Texas, Md Anderson Cancer Center and classified as a Class 2 device.
What It Is
The Radiation Planning Assistant is a web-based tool that automates radiotherapy contouring and planning. It is intended to support clinics with limited resources by providing automated treatment planning capabilities.
FDA-Cleared Indications
- Software for automated radiotherapy treatment planning and related contouring tasks.
- Intended to support the preparation of radiation treatment plans in clinical radiotherapy practice.
Clinical Applications
- Automated contouring of relevant anatomy for radiotherapy planning.
- Automated generation or assistance with radiotherapy treatment plans.
- Support for radiation oncology clinics with limited treatment-planning resources.
- Use as part of the clinical workflow for preparing plans that are reviewed and approved by qualified radiation oncology professionals.
Evidence Summary
The available literature includes 10 studies, with types ranging from RCTs to retrospective analyses, published between 2023 and 2024. These studies focus on the feasibility and clinical acceptability of the RPA.
Reported Outcomes
Published studies report that the RPA can significantly reduce radiotherapy planning time and improve workflow efficiency in resource-constrained settings. It has been shown to enhance the ability of clinics to deliver timely cancer care.
Safety Profile
Reported complications include potential errors in automated contouring, which require clinician oversight. No significant adverse events have been reported in the studies reviewed.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on low-resource settings. Further research is needed to assess long-term outcomes and the device's applicability in diverse clinical environments.
Practical Considerations
- The RPA is software rather than an implanted or handheld medical device; it is used through a web-based workflow.
- Treatment plans require review and clinical approval by qualified radiation oncology personnel before treatment.
- The software must be used with compatible imaging, patient information, treatment-planning, and radiation-delivery systems as specified by its labeling and local implementation requirements.
- MRI safety considerations apply to the imaging equipment and accessories used in the workflow, not to the web-based RPA software itself.
- The FDA clearance does not eliminate the need for institutional quality assurance, cybersecurity controls, data protection, and verification of the final treatment plan.
Frequently Asked Questions
What are the clinical indications for Radiation Planning Assistant RPA?
The RPA is indicated for use in automating radiotherapy planning, particularly in clinics with limited resources.
What outcomes have been reported in clinical studies?
Studies report improved planning efficiency and enhanced access to radiotherapy services in low-resource settings.
What complications have been reported?
Safety data indicate potential errors in automated contouring, necessitating clinician oversight.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.