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RTIS is an imaging accessory indicated for use with radiotherapy devices such as linear accelerators and simulators. It provides radiographic/fluoroscopic images for simulations, and portal images for high energy treatment machines.

RTIS is a component of imaging systems for use with radiotherapy devices such as linear accelerators and simulators for various imaging tasks. It may be integrated into systems such as Varian PortalVision® and VARiS® Digital Imaging Option and offers the capability of a realtime imager that can provide both high quality simulator fluoroscopic/radiographic images and high energy treatment images.

This document is a 510(k) premarket notification for the "Varian Radiation Therapy Imaging System (RTIS)". It describes the device, its intended use, and technological considerations, but does not contain details about acceptance criteria or a study proving its performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, or standalone performance) from the provided text.

The document primarily focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device, rather than providing a performance study report.

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