(17 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 can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo via MI workflows support the interpretation and evaluation 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 SPECT Processing feature resides within synqo.via MI Workflows and is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens synqo.via MI Workflows software platform by trained service personnel.
syngo.via MI Workflows is a medical diagnostic application 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. synqo.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. 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 syngo.via MI Workflows (K151192) include the addition of the SPECT (Organ) Processing feature within the MI Reading workflow. This feature will integrate already existent functionality from Symbia 6.0, MI Applications (K142006) and provide the user additional organ-specific functionality for Nuclear Medicine (NM) and SPECT images within the syngo.SPECT Processing workflow.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device syngo.via MI Workflows meets those criteria. Instead, it describes the device, its intended use, and its equivalence to a predicate device for the purpose of 510(k) clearance by the FDA.
The text states that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitiqations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not provide the specifics of these "predetermined acceptance values" or the "performance requirements and specifications."
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance. The document broadly states "All testing has met the predetermined acceptance values" but does not define these values or present specific performance data.
- Sample size used for the test set and the data provenance. This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This information is not present.
- Adjudication method for the test set. This information is not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done. This information is not present. The document focuses on showing equivalence to a predicate device rather than comparative effectiveness.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. This information is not present. The device is described as a tool to aid human interpretation ("The clinician retains the ultimate responsibility...").
- The type of ground truth used. This information is not present.
- The sample size for the training set. This information is not present.
- How the ground truth for the training set was established. This information is not present.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include the information you've requested.
§ 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).