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The Siremobil Iso-C 3D with extended Indications for Use is based on Siemens isocentric mobile C-arm, marketed as Siremobil Iso-C 3D. The extended Indications for Use include the high contrast objects and anatomical structures of the entire body. The Siremobil Iso-C 3D contains no new hardware or software.

The Siremobil Iso-C 3D is designed as a 3D imaging device and is intended to be used whenever the physician benefits from intraoperatively generated 3D information of high contrast objects and anatomical structures.

The Sirernobil Iso-C 3D is an isocentric mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a monitor trolley which consists of the digital memory device, image monitor(s), and user interface. The 3D imaging option allows the reconstruction of two-dimensional images acquired with a mobile isocentric C-arm device into a three-dimensional image format.

The provided text does not contain information about acceptance criteria or a study proving that the Siemens Siremobil Iso-C 3D device meets specific acceptance criteria. The document is a 510(k) summary for the device, detailing its description, intended use, and substantial equivalence to a predicate device, as well as the FDA clearance letter. It does not include performance metrics or study designs for meeting acceptance criteria.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth establishment, or expert adjudication based on the given input.

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