(15 days)
The intended use of the device is to support and aid in positioning a patient during radiation therapy.
The HexaPOD consists of two platforms, which are connected by six linear, rigid but length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
The provided document is a 510(k) Premarket Notification for a medical device called the HexaPOD™ RT Couch Top. It outlines the device's description, intended use, and its substantial equivalence to a predicate device.
However, the document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because no such studies were required or performed for this specific device submission.
The 510(k) submission for the HexaPOD™ RT Couch Top focuses on demonstrating substantial equivalence to a previously legally marketed device (Medical Intelligence's "HexaPOD RT Couch Top") rather than proving novel performance against specific acceptance criteria through new clinical or performance studies. The modifications made were evolutionary hardware changes and implementing additional safety functions, which did not trigger a requirement for new performance data.
§ 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.