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syngo Colonography - Software Package with Extended Functionality is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT or MR scanning.

The syngo Colonography - Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Polyp Enhanced Viewing), Furthermore workflow improvements, like "segmentation in global view". "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package.

This visualization tool allows for volumetric analysis of colonic lesion size over time. helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position.

The syngo Colonography - Software Package with Extended Functionality is limited to CT volume data sets.

This pre-market notification covers Siemens syngo Colonography - Software Package with Extended Functionality. It is based on Siemens syngo software platform.

syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or lowdose spiral CT or MR scanning.

The syngo colonography Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Polyp Enhanced Viewing). Furthermore workflow improvements, like "segmentation in global view", "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package.

This visualization tool allows for volumetric analysis of colonic lesion size over time, helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position.

The provided document describes the "syngo Colonography - Software Package with Extended Functionality" (K042605). However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on:

• General Information: Device name, classification, manufacturer, contact.
• Substantial Equivalence: Comparing the device to a predicate device (syngo Colonography Software Package, K030982) and stating that it does not introduce new safety risks.
• Device Description and Intended Use: Explaining what the software does (image analysis for evaluating CT/MR volume data, supporting physicians in identifying colon lesions, volumetric analysis, etc.) and new features (Polyp Enhanced Viewing, segmentation in global view, automatic size measurement, synchronization of prone and supine, unseen areas).
• FDA Clearance: The official letter from the FDA confirming clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions because the necessary information is not present in the provided text.

Based on the provided text, I can only state the following:

• Study Information: The document states that "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." This indicates that some form of internal testing was conducted for safety and effectiveness, but no details of these tests (e.g., specific acceptance criteria, performance metrics, or study design) are provided.
• Substantial Equivalence: The primary "proof" of the device meeting its intended purpose and safety is its substantial equivalence to a previously cleared predicate device (syngo Colonography Software Package, K030982). The assumption is that if the predicate device met certain criteria, and the new device is substantially equivalent with new features, those new features also meet those implicit criteria through validation testing.

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