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The Integris 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.

The Integris 3D-RA option is comprised of an image processing computer loaded with 3D-RA software. It is linked through a DICOM port to the Integris system and is intended to be placed in the control room of the Angiography suite. The set of 2-Dimensional images from the rotational angiographic examination are transferred via DICOM Connection to the 3D RA Workstation. A 3-Dimensional image is reconstructed from the delivered image information resulting in an object which can be viewed from almnost any angle.

The provided text is a 510(k) summary for the Philips Integris 3D RA Option. It describes the intended use and system description but does not contain any information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study and its methodology based on the provided input. The document mentions "software validation statement, test activities and external evaluations by hospitals" as part of their risk management plan, but no specifics are given.

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