(35 days)
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensator and an aperture.
The range compensator is made out of acrylic or wax. The custom shape/design specifications for range compensators are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.
.decimal's Range Compensator manufacturing service manufactures the solid Range Compensators for intensity modulation of external beam proton radiation therapy. The Range Compensator are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
This appears to be a 510(k) premarket notification summary for a medical device called the ".decimal Range Compensator." It describes the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document focuses on regulatory information for market clearance, not on a detailed scientific study.
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.