(184 days)
Somavision is an advanced treatment planning preparation workstation for the physician and include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Vision database.
Somavision is an advanced treatment planning preparation workstation with 3D image capabilities.
This document is a 510(k) Premarket Notification for the Varian SomaVision 6.0 device. It describes the device's intended use and technological characteristics, and ultimately summarizes the FDA's decision regarding its substantial equivalence to a predicate device.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot fulfill your request for this specific information based on the provided document. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not on detailed performance study results that would typically include acceptance criteria and study methodologies.
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.