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syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel.

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

synqo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

Scenium is a previously cleared software device (K191309) that assists in the display and analysis of images within the MI Neurology workflow of syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.

Scenium consists of four workflows:

• Database Comparison -
• -Striatal Analysis
• -Cortical Analysis
• -Subtraction

The Scenium workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).

syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The software sites within the MI Cardiology workflow within syngo.Via MI Workflows. The application supports dynamic Rubidium - PET and dynamic Ammonia – PET images. The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, such as a database comparison workflow, for the Clinician to assess these results.

The provided text is a 510(k) Summary for the Siemens syngo.via MI Workflows VB50A. It details the device's intended use and technological characteristics but does not include a study specifically testing acceptance criteria for device performance, nor does it provide a table of acceptance criteria and reported device performance.

The document indicates 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 mitigations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not elaborate on what these "predetermined acceptance values" or "performance requirements and specifications" were, nor does it present the results of such testing.

Therefore, I cannot fulfill most of the requested information based on the provided text.

Here's what can be extracted based on the limitations:

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

• Cannot be provided. The document states that "All testing has met the predetermined acceptance values" but does not define these values or the specific performance metrics achieved.

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

• Cannot be provided. The document does not mention any specific test set, its size, or its provenance.

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)

• Cannot be provided. The document does not describe any process for establishing ground truth using experts.

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

• Cannot be provided. The document does not describe any adjudication method.

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

• Cannot be provided. The document does not mention an MRMC comparative effectiveness study or any effect sizes related to human reader improvement with AI assistance.

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

• Cannot be provided. The document generally describes the software features but does not provide details of standalone performance testing.

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

• Cannot be provided. The document does not specify any type of ground truth used for performance evaluation.

8. The sample size for the training set

• Cannot be provided. The document does not mention any training sets or their sizes.

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

• Cannot be provided. The document does not mention any training sets or how their ground truth was established.

Summary of what the document does provide regarding testing:

• General Statement: "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 mitigations have been fully implemented. All testing has met the predetermined acceptance values."
• Standards Followed: Risk Management in compliance with ISO 14971, and development adhered to EN ISO 13485 and IEC 62304.
• Cybersecurity: "The Clinical Applications software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Clinical Applications software and external devices."

In conclusion, while the document indicates that verification and validation were performed and acceptance values were met, it lacks the specific details about these studies, acceptance criteria, and performance results that your request asks for. This type of detailed study information is typically found in the full 510(k) submission, not always in the public-facing 510(k) Summary.

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