(209 days)
The syngo MultiModality Workplace is intended to be used for viewing, manipulation, communication, and storage of medical images and data exchange media.
The syngo MultiModality Workplace can be used as a stand-alone device or as with a variety of cleared and unmodified syngo- and Windows XP-based software options.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
This premarket notification covers only the Siemens syngo MultiModality Workplace (sMMWP) (VE26A), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syngo MultiModality Workplace (sMMWP) (VE26A) offers a comprehensive solution to view, optimize process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.
Due to special customer requirements based in the modality image type and the clinical focus, the syngo MultiModality Workplace (sMMWP) (VE26A) can be offered with different combinations of cleared and unmodified clinical applications. syngo applications can be added to the MultiModality Workplace either individually or as clinically focused packages.
The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. This 510(k) summary focuses on establishing substantial equivalence to a predicate device based on intended use and similar technological characteristics, rather than presenting a performance study with detailed acceptance criteria.
Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states: "Siemens is of the opinion that the syngo MultiModality Workplace (sMMWP) (VE26A) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device." This indicates that the primary method for demonstrating safety and effectiveness was through comparison to an already cleared device, not through a new performance study with defined 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).