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The Allura 3D-CA release 1 is intended to assist physicians when analyzing 2-Dimensional X-ray images by creating 3-Dimensional views from a pair of 2-Dimensional images created during rotational angiographic runs.

The Allura 3D-CA release 1 device contains an image processing computer loaded with 3D-CA application software. It is linked through a DICOM port to a Philips Cardio-Vascular X-ray system and is intended to be placed in the control room of the Angiographic suite. 3D Coronary Angiography refers to 3D scanning of the coronary arteries, employing a C-arm based X-ray system. 2D projections are generated during a rotational scan, in which the patient's heart is scanned over an angular range of ca. 100-120 degrees. The complexity of making a 3D image of the coronary arteries is mainly caused by motion of the heart. 3D-CA uses a cardiac modeling technique to obtain a still 3D model of the heart. Cardiac modeling allows the construction of a 3D surface model of a coronary segment, or multiple segments, from two 2D projection images.

The provided text from the 510(k) submission for the "Allura 3D-CA, release 1" device does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Integris 3D-RA release 4.2) and confirming compliance with general safety and effectiveness regulations, such as DICOM standards and UL safety standards.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

This submission is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria.

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