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The Portal Vision™ Advanced Imaging device is used to acquire images of anatomical landmarks, fiducial markers, the shape of the treatment beam and dosimetric signals to guide the delivery of radiation anywhere in the body where radiation treatment is indicated.

The Portal Vision Advanced Imaging (PVAI) device combines two previously cleared Varian Medical Systems devices into a single device. The PVAI device provides hardware and software for acquiring MV images and is an accessory to Varian Linear Accelerator devices. The hardware component of PortalVision™ Advanced Imaging consists of a detector support arm known as the R-Arm or Exact Arm, and an image acquisition system that provides highquality radiographic images and high-energy treatment images. The software component of the modification known as PortalVision™ Advanced Imaging provides additional capability to remotely correct the patient position from the treatment console.

The provided text is a 510(k) summary and FDA clearance letter for the Varian PortalVision Advanced Imaging device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, or performance data beyond the statement of substantial equivalence.

Therefore, I cannot fulfill your request for the detailed table and study information because the required data is not present in the provided input.

The document focuses on regulatory clearance based on substantial equivalence, and not on presenting a detailed performance study with acceptance criteria.

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