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CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print and distribute colon image studies.

CT Colonography II is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D, 3D and 360 dissection views, and an object oriented endoluminal display.

The provided text is a 510(k) summary for the GE Medical Systems CT Colonography II device. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

Specifically, the document focuses on:

• Product Identification: Name, classification, manufacturer, distributor, and predicate device.
• Device Description: What the device is and its functions (visualization of 2D/3D medical image data of the colon, bookmarking, synchronized viewing, endoluminal display).
• Indications for Use: Screening of a colon to detect polyps, masses, cancers, and other lesions.
• Comparison with Predicate: States substantial equivalence to the CT Colonography (K023943).
• Adverse Effects on Health: Identifies potential hazards managed through software development, validation, verification processes, and adherence to standards.
• Conclusions: No new safety risks, performs as well as existing devices, equivalent to the predicate.
• FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence.

Therefore, I cannot provide the requested table or additional information as the document does not contain the necessary data regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or comparative effectiveness details.

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