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syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization 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 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 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 (K160426) include the following new features:

MM Oncology Multi-foci-Segmentation Quick Quant Updates to OncoBoard VA20 Customer acceptance/ usability improvements MI Neurology:

Ability to set a default layout for Neurology studies

MI Cardiology:

Updates / redeployment to third party software Improved launching performance of third party software

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the syngo.via MI Workflows, a software-only medical device. However, it does not contain specific acceptance criteria or quantitative performance metrics for the device's diagnostic capabilities. The submission focuses on the substantial equivalence of the updated software version (VB20A) to a previously cleared version (VB10B), emphasizing that the new features do not alter the fundamental technological characteristics or raise new safety/effectiveness issues.

Therefore, a table with specific acceptance criteria and reported device performance cannot be generated from the given text. The document refers to "predetermined acceptance values" for internal verification and validation but does not provide these values publicly.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Verification and Validation activities have been successfully performed on the software package," but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number of experts used to establish ground truth for any test set or their qualifications.

4. Adjudication Method:

The document does not provide information on any adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The focus is on the software's capabilities for visualization, manipulation, and analysis, not comparative diagnostic performance.

6. Standalone Performance Study:

The document describes the device as "software only" and details its features for "viewing, manipulation, 3D-visualization and comparison of medical images." It states that "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." This indicates that the device is intended for human-in-the-loop use as a tool to aid interpretation, rather than a standalone diagnostic algorithm. Therefore, a standalone performance study in the sense of an algorithm-only diagnostic output is not described or implied.

7. Type of Ground Truth Used:

The document does not specify the type of ground truth used for any testing.

8. Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The submission is for an updated version of existing software, and details about initial development or machine learning training are not included.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for any training set was established.

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