(78 days)
RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI Among the generated plans, the user selects and climically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the pattent
RayAutoplan is a stand-alone software program that generates a number of treatment plans, based on the dose distribution exported from a TomoTherapy treatment planning system. To execute, RayAutoplan needs the following unput: A patient description, normally CT images and regions of interests. A dose distribution serving as a reference dose, which should be benchmarked. As output, RayAutoplan produces a inac IMRT treatment plan and the corresponding dose distribution from an accurate calculation of the dose engine plan to DICOM archive or R&V system. The software runs on a Windows XP or Windows Vista platform.
The provided text for the RayAutoplan device does not contain information about acceptance criteria or specific studies proving the device meets them. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing performance studies against defined acceptance criteria.
Therefore, I cannot provide the requested information in the tables or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.
The document mainly covers:
- Device Description: RayAutoplan is a stand-alone software that generates multiple IMRT treatment plans based on dose distributions from a TomoTherapy system.
- Intended Use: To generate individualized IMRT plans, present their characteristics, allow user selection and clinical approval, and export electronically for patient treatment. Intended users are clinically qualified staff (medical physicists, medical doctors, dosimetrists).
- Predicate Device: Oncentra MasterPlan v3.1 (K081281).
- Technological Characteristics Summary: Stating that RayAutoplan's technological characteristics are the same as the predicate device, producing IMRT plans with collapsed cone dose engine calculations, electronic clinical approval, and DICOM export.
- 510(k) Clearance Letter: Confirming that the device is substantially equivalent to legally marketed predicate devices.
To answer your request, information typically found in a clinical or performance evaluation report would be needed, which is not present in this 510(k) summary.
§ 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.