(251 days)
The Radiation Planning Assistant (RPA) is used to plan radiotherapy treatments with cancers of the head and neck, cervix, breast, and metastases to the brain. The RPA is used to plan external beam irradiation with photon beams using CT images. The RPA is used to create contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for review, editing, and re-calculation of the dose.
Some functions of the RPA use Eclipse 15.6. The RPA is not intended to be used as a primary treatment planning system. All automatically generated contours and plans must be imported into the user's own treatment planning system for review, edit, and final dose calculation.
The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
Here's a breakdown of the acceptance criteria and study information for the Radiation Planning Assistant (RPA) device:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Number | Criteria | Reported Device Performance (Overall, across all sites/anatomical locations where available) |
|---|---|---|
| 1. | Assess the safety of using the RPA plan for normal structures for treatment planning by comparing the number of patient plans that pass accepted dosimetric metrics when assessed on the RPA contour with the number that pass when assessed on the clinical contour. The difference should be 5% or less. When there are multiple metrics for a single structure at least one should pass this criterion. | Cervix: 0.7 |
| Head & Neck: 25th percentile for recall > 0.7 | ||
| 5. | Assess the quality of body contouring generated by the RPA by comparing primary and secondary body contours generated by the RPA with manual body contours. Surface DSC (2mm) should be greater than 0.8 for 95% of the CT scans. | Cervix: Surface DSC > 0.8 for 95% of CT scans |
| Chest Wall: Surface DSC > 0.8 for 95% of CT scans | ||
| Head & Neck: Surface DSC > 0.8 for >95% of CT scans | ||
| Whole Brain: > 0.8 difference between RPA Plan and Clinical Plan for all assessments. | ||
| 6. | Assess the ability of the RPA to accurately identify the marked isocenter. This is achieved by comparing the automatically generated isocenters with manually generated ones. 95% of automatically generated marked isocenters (primary and verification approaches) should agree with manually generated marked isocenters within 3mm in all orthogonal directions (AP, lateral, cranial-caudal). | Cervix: |
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.