(11 days)
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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. 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 or MR 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 unambiguously, with respect to their size, dimensions. shape and position.
Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.
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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. 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 or MR 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 unambiguously, with respect to their size, dimensions, shape and position.
I apologize, but the provided text does not contain detailed information about acceptance criteria or specific study results that prove the device meets said criteria.
The document is a 510(k) summary for the Syngo Colonography software package, primarily focused on establishing substantial equivalence to previously cleared predicate devices. It describes the device's intended use, general safety and effectiveness concerns, and its relationship to other Siemens software.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions regarding:
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed study information is typically found in the full 510(k) submission, not necessarily in the public summary. The summary focuses on the regulatory aspects of equivalence rather than a detailed performance report against specific acceptance criteria.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).