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The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

The present device (K040192) is cleared to make corrections to a patient's position based on a comparison of the newly acquired digital kV Xray images with digital reference images generated during treatment planning or simulation. Regarding this submission, the On-Board Imager has been modified to include correction of a patient's position based on comparison of fiducial markers in digital images to fiducial markers that are in reference 3-D volumetric data sets and allow for gated radiographic image acquisitions and fluoroscopic pretreatment visual verification.

The provided document is a 510(k) summary for the Varian Medical Systems On-Board Imager, a medical device used for verifying patient position and treatment fields in relation to anatomical and/or fiducial landmarks during radiation therapy. It outlines the device description, intended use, and substantial equivalence to a predicate device (Varian Medical Systems' On-Board Imager, K040192).

However, the document does not contain specific details regarding acceptance criteria, study design, statistical analysis, or performance metrics that would allow for a complete response to your request. The 510(k) summary primarily focuses on regulatory approval based on equivalence to a previously cleared device.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The document indicates that "The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission." This chart, if available, would likely contain more technical specifications and potentially some performance data used for the substantial equivalence claim. However, the content of Tab 8 is not included in the provided text.

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