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510(k) Data Aggregation
(234 days)
The PlanOne is a software system used to plan radiotherapy treatments for patients with malignant or benign diseases. PlanOne is used to plan external beam irradiation with photon and proton beams. The intended users of PlanOne shall be clinically qualified radiation therapy staff trained in using the system.
The Cosylab Treatment Planning System (PlanOne) is responsible for creating machine instructions (treatment plans) for radiotherapy. It's a complex piece of software, integrating detailed physics (dose calculation), mathematics (plan optimization) and graphical (contouring) algorithms.
The PlanOne has to import 3D image datasets of patient anatomy, usually CT images. In the first stage of the planning, the tumor and critical structures have to be identified by the user. The process is called contouring. In the second stage, the 3D image and the contours are taken along with prescription input to calculate a treatment plan. The treatment plan includes machine instructions on how to deliver radiation.
To produce an appropriate treatment plan, the PlanOne computes the expected dose distribution in the patient's anatomy, taking into account relative electron density and particle stopping material properties at specific voxels (pixels). The PlanOne also helps to navigate beam placement based on avoiding critical structures that are more sensitive to radiation in an effort to reduce collateral damage from the therapy. The PlanOne may optimize beam shape and intensity to meet the user set objectives. This may include automated, complex programming for multi-leaf collimator (MLC) leaf sequencing to shape the beam around critical structures during dose delivery. In particle therapy instead of shaping MLC, the PlanOne determines the appropriate spot placement and weight in each beam direction.
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