(39 days)
The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
The RoboCouch Patient System is an electric computer-controlled treatment table for supporting and positioning a patient during radiosurgery, radiotherapy and other medical procedures requiring precise positioning. The RoboCouch is mounted on a robotic arm with 6 degrees of freedom.
The provided text is a 510(k) summary for the RoboCouch Patient Support System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria, as the necessary information is absent from the provided text.
The 510(k) summary provided is focused on demonstrating substantial equivalence to already marketed devices, which is a regulatory pathway for lower-risk devices. This often means that extensive new clinical studies with detailed performance metrics against specific acceptance criteria (as would be seen for a novel, higher-risk device) are not required or detailed in this type of submission document.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.