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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 data sets. 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 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 of examinations and followup 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. 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 (K123577) is adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment. This change is based on current commercially available software features and does not change the technological characteristics of the device.

syngo via MI Workflows are intended to be run on the Siemens syngo.via software platform (K123375) either alone or with other advanced commercially cleared applications.

The provided text (K133644, Siemens Medical Solutions USA, Inc., syngo.via MI Workflows) is a 510(k) summary and FDA clearance letter, which describes the device and its intended use but** does not contain information about acceptance criteria, specific studies, or performance metrics in the way requested.**

The document states that the modification to the previously cleared syngo.via MI Workflows (K123577) is "adding a new feature allowing the physician to harmonize SUV data based on a standard reference value, allowing comparison of scans acquired over multiple timepoints or using different scan parameters or equipment." It also notes that this change "does not change the technological characteristics of the device" and that "no changes that raise any new issues of safety and effectiveness as compared to the predicate device."

Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions relating to specific acceptance criteria, study details, and performance results.

However, I can extract information related to the device and its general validation:

1. A table of acceptance criteria and the reported device performance

No specific study is described in detail within these documents. The information provided discusses verification and validation activities generally, but not a specific clinical or performance study with defined acceptance criteria and performance results directly linked to the SUV harmonization feature.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document states "Verification and Validation activities have been successfully performed" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not provided. The document focuses on the software's functional capabilities (SUV harmonization) and its substantial equivalence, not on comparative effectiveness studies involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Given the nature of the device as "Image Processing Software" that "provide analytical tools to help the user assess, and document changes," it is inherently a human-in-the-loop device. No standalone performance metrics are provided or implied for automated decision-making without a clinician. The "Note" in the Indications for Use explicitly states: "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."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not provided. The document does not describe the specific ground truth methodologies used for its "Verification and Validation activities."

8. The sample size for the training set

• Not provided. The document describes a software modification to an existing product and does not indicate details about machine learning model training.

9. How the ground truth for the training set was established

• Not applicable / Not provided. As no training set details are mentioned, the method for establishing its ground truth is also not provided.

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