(63 days)
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo.via MI Workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
The syngo.via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morpholoqical or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions. for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
The modifications to the synqo.via MI Workflows (K113029) are adding enhanced functionality to the commercially available Oncology workflow in this software. All changes are based on current commercially available software features and do not change the technological characteristics of the device.
syngo.via MI Workflows are intended to be run on the Siemens synqo.via software platform (K123375) either alone or with other advanced commercially cleared applications.
The provided text is a 510(k) Premarket Notification for the Siemens syngo.via MI Workflows device. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device (K113029).
However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on:
- Identification of the Submitter and Product
- Marketed Devices to which Equivalence is claimed (predicate device)
- Device Description: What the software does (viewing, manipulation, 3D visualization, comparison of medical images from multiple modalities and time-points, support for functional and anatomical data, analytical tools for assessment and documentation of changes).
- Safety and Effectiveness: Mentions compliance with ISO 14971:2007 for risk management, ISO 13485 and IEC 62304 for development, and that "Verification and Validation activities have been successfully performed."
- Indications for Use: Reiterates the device's functionality and its role as a complement to clinician diagnosis.
- Conclusions: States substantial equivalence to the predicate device and no new safety or effectiveness issues.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The document is a submission for regulatory clearance based on substantial equivalence to a predicate device, and thus typically does not include detailed performance studies with acceptance criteria in the summary provided. Such details would usually be found in the comprehensive technical documentation submitted to the FDA, but not necessarily in the publicly available 510(k) summary.
§ 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).