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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 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,

The syngo.via MI Workflows are based on the syngo.PET&CT Oncology package (K093621and are merely adding the ability to launch additional commercially available software such as Siemens Scenium product (K061545) on the syngo.via platform.

syngo.via MI Workflows are intended to be run on the Siemens syngo.via software platform (K092519) either alone or with other advanced commercially cleared applications.

The provided document, K113029 for syngo.via MI Workflows, does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for performance evaluation of diagnostic algorithms.

This device is described as "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." Its primary function is for "viewing, manipulation, 3D-visualization and comparison of medical images...[providing] analytical tools to help the user assess, and document changes..."

The submission makes an equivalency claim to previously cleared Siemens devices (K092519 and K093621) and does not present new performance data or a clinical study for this specific 510(k) submission. Therefore, many of the requested elements regarding acceptance criteria, study design, and performance metrics are not applicable or not provided in this document.

Here's an assessment based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for an AI algorithm or analytical tool, nor does it report device performance against such criteria. The device's clearance is based on substantial equivalence to existing predicate devices, implying its performance is comparable to or does not raise new questions of safety and effectiveness compared to those devices for its stated functions of image viewing, manipulation, visualization, and comparison.

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

Not applicable. No new test set data or studies are presented.

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

Not applicable. No new test set data or studies are presented.

4. Adjudication Method for the Test Set

Not applicable. No new test set data or studies are presented.

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

Not applicable. An MRMC study was not conducted or reported for this submission. The device provides "analytical tools to help the user assess, and document changes," but there is no comparative effectiveness study on human readers with vs. without AI assistance described.

6. Standalone (Algorithm Only) Performance Study

Not applicable. A standalone performance study was not conducted or reported for this submission. The device is a software application designed for human review and analysis.

7. Type of Ground Truth Used

Not applicable. No new performance studies or ground truth establishment are detailed in this 510(k) summary.

8. Sample Size for the Training Set

Not applicable. No new training set or algorithm development data are detailed in this 510(k) summary.

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

Not applicable. No new training set or algorithm development data are detailed in this 510(k) summary.

Summary of Device Rationale for Clearance:

The K113029 submission for syngo.via MI Workflows primarily relies on demonstrating substantial equivalence to previously cleared Siemens products (syngo.via (syngo.x) K092519 and syngo.via MI Workflows (syngo.via PET&CT Oncology) K093621). The document states that the new device is "based on the syngo.PET&CT Oncology package (K093621) and are merely adding the ability to launch additional commercially available software such as Siemens Scenium product (K061545) on the syngo.via platform."

The safety and effectiveness argument is based on:

• Risk Management via risk analyses in compliance with ISO 14971:2007.
• Adherence to recognized and established industry standards for development.
• The device labeling containing instructions for use and any necessary cautions and warnings.

In essence, this 510(k) is for updates and integration capabilities of existing, cleared functionalities, rather than for a novel diagnostic algorithm requiring a new performance study to establish its efficacy or accuracy with specific acceptance criteria.

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