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CADENS™ Colon is a self-contained image analysis software package for evaluating CT volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-luminal view), the wall and the outside (extra-luminal view) of the colon. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue, with respect to their size, dimensions, shape and position.

It is to be used only by trained and instructed health care professionals.

Similar to the Siemens Syngo Colonography software package, VIATRONIX V3D Colon and VITAL Images CT Colonography, the CADENS™ Colon is indicated for use and designed for the support of authorized physicians in reviewing relevant CT scanner images of Colorectal Cancer patients. The CADENS™ Colon is similar in intended use to the above Siemens and VITAL Images solutions combined with the electronic cleansing intended use of the Viatronix medical device.

This document, K111758, is a 510(k) summary for CADENS™ Colon, a self-contained image analysis software package for evaluating CT volume datasets related to colorectal cancer. The document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

The submission focuses on establishing substantial equivalence to predicate devices (Siemens Syngo Colonography software package, VITAL Images Vitrea, and Viatronix V3D Colon) based on similar intended use and technological characteristics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as these details are not present in the provided text.

The closest sections that describe general testing are in "8. General Safety and Efficacy examination," which states: "CADENS™ Colon has been tested and verified in various phases, including design review, internal verification and validation. The design was verified throughout a design process; internal validations included bench testing and practical testing in a simulated clinical environment. Hazard analysis was carried out during a Risk Management Plan, and appropriate measures were implemented and their effectiveness was verified." This is a high-level overview and lacks the specifics required to answer your questions.

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