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The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that enables radiologists to view, analyze, register and compare new and previous series of thoracic CT images. The software package assists the radiologists by calculating volume change and doubling time of selected segmented candidate thoracic abnormalities, such as pulmonary and pleural nodules and lesions, found on these images.

The software is designed to assist the radiologists in characterization and classification of these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and position and thus aid in the patient management care decision process.

The C-CAT software is dedicated to assist the radiologist in assessing multiple CT case studies as well as any selected abnormal thoracic regions of interest (ROI's), such as pulmonary lesions, nodules, etc. It enables:

• a) a detailed visualization and analysis of the CT slices using tools such as Multi-Planar Reformat and Sliding Maximum Image Projection;
• b) a comparative analysis of the aligned, simultaneously presented current and previous CT images with findings and selected ROIs with their size (volumetric and diameter) measurement displayed for assessment of volume change and doubling time; and
• c) review of software-generated comparative reports that present information such as development of new lesions, prior lesion's progression and doubling time. This software tools package is designed for use with the ImageChecker CT Workstation (K023003, cleared 11/20/02) and other CT workstations that utilize the ImageChecker CT Workstation software tools.

The provided text is a 510(k) summary for R2 Technology's Comprehensive Chest Analysis Tools (C-CAT). It describes the device, its intended use, comparison with predicate devices, and the FDA's clearance letter. However, it does not contain details about specific acceptance criteria or the study that proves the device meets those criteria, or any of the detailed information requested in the prompt.

The document only states: "The Comprehensive Chest Analysis Tools package will undergo design verification tests for conformance with specifications." This indicates that such tests were planned or conducted, but no results, methodology, or specific acceptance criteria are presented in this summary.

Therefore, I cannot provide the requested table and information based on the given input, as the study details are explicitly missing.

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