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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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To assist the therapist in verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment.

VARiS PortalVision™ is an on-line electronic portal imaging system which allows for verification of the treatment field and shielding blocks in relation to anatomical landmarks in radiotherapy treatment. The imaging mechanism of VARiS PortalVision™ is an ionization chamber.

VARiS PortalVision™ is fully integrated into Varian's VARiS environment. It is a subsystem of the VARiS Images application. The VARiS PortalVision™ software supports image acquisition, image processing, and image evaluation by means of quantitative comparison tools.

As a subsystem of VARiS Images, VARiS Portal Vision™ runs on the VARiS Images workstation. The VARiS Images workstation is based on an Intel Pentium processor based PC running Microsoft Windows NT or the Win 95 operating system.

The provided text is a K955774 submission for the VARiS PortalVision™ device. It describes the device, its intended use, and technological considerations, but it does not contain information about acceptance criteria, a study proving performance against those criteria, or details regarding ground truth, sample sizes, or expert involvement for assessing performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document primarily focuses on the device's description, predicate comparison, and intended use as part of a 510(k) submission, which typically outlines the device's functionality and its substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria and clinical results.

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