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The Varian Ximatron ScanVision CT device is an attachment to the Varian Radiation therapy simulator Ximatron. It is to be used to obtain CT images of the patient in the intended treatment position, for the purposes of radiation therapy treatment planning.

The Varian Ximatron ScanVision is an attachment to the Varian Radiation therapy simulator Ximatron. ScanVision is a hardware computed tomography acquisition system, based on Varian Ximiatron radiation therapy simulator. It acquires CT silce Infornation as digital images from the Ximatron simulator. These images may be viewed and manipulated prior to being made available to the doctor for planning the treatment. In combination with XimaVision, which is an integral part of ScanVision, either: - the doctor can specify and mark on the flattened fluoro image where he wants the slices to be taken . or - t after the slices have been taken, the slice positions can be automatically marked on the fluoro image. ScanVision is also linked to the Ximitron for automatic set-up of the Ximatron and the X-ray generator for scanning.

The provided text is a 510(k) Premarket Notification summary for the Varian Ximatron ScanVision with Version 5.0 Software. This document primarily focuses on establishing substantial equivalence to a predicate device (Varian Ximatron CT Option cleared to market per 510(k) No. K910647) for regulatory clearance, rather than detailing a specific study to prove the device meets acceptance criteria developed for this specific device.

The document outlines the device's intended use and technical description, but it does not contain the specifics of a study designed to demonstrate performance against defined acceptance criteria. This type of information (detailed performance metrics, sample sizes, ground truth establishment, etc.) is typically found in design validation reports or clinical study summaries, which are often provided to the FDA as part of the 510(k) submission but are not always part of the publicly available 510(k) summary.

Therefore, I cannot fulfill your request for the specific acceptance criteria and the details of a study proving the device meets them from the provided text. The document focuses on regulatory equivalence, not detailed performance validation against specific acceptance metrics.

In summary, the document provided does NOT contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance validation.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document's primary purpose is to inform the FDA that the Varian Ximatron ScanVision is substantially equivalent to a previously cleared device, based on its intended use and functional description.

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