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The SYNGO workstation encompasses a number of software applications for viewing, processing, filming, and archiving of medical images. VSim is one of the software applications that are offered on the SYNGO workstation, K010938.

VSim permits CT Simulation to be performed on the SYNGO workstation. The CT scans are first loaded into the VSim software. On VSim the user is able to create 3D models of targets and organs. On VSim the user is able to identify the patient isocenter, place treatment beams and identify beam modifiers (blocks, apertures, and MLCs). This information is then sent to a radiation treatment planning system for dose calculation. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.

Siemens Virtual Simulation (VSim) is a software application that runs on Siemens Medical Workstation, Syngo (K010938). It is intended to give the user general Viewing & Examination tools for viewing medical diagnostic images. Computed Tomography (CT) scans are the centerpiece of the diagnostic images used by the VSim. It will be possible to load other modality images, Positron Emission Tomography (PET) and Magnetic Resonance (MR), in conjunction with the CT images for treatment planning.

VSim is intended to provide tools for delineating and representing targets and critical Structures. It takes specifications and dimension for the dose delivery system (Siemens and other vendors). It will then enable the user to design complex beam profiles and place them for optimum treatment of the discase. 3D Graphical representation and visualization of all the relevant objects allow for a virtual setup and treatment of the patient without involving the patient.

VSim is a 3D post-processing software application that uses CT planning images as input and creates the following data objects as output:

1. Structure sets stored in the form of DICOM-RT Structure-Set,
2. Reference Points (including isocenters) stored in the form of DICOM-RT Structure-Set.
3. Plans, including beams stored in the form of DICOM-RT-Plan, and
4. Reference Images in the form of Digitally Reconstructed Radiographs (DRRs), (one DRR for each beam in the plan) stored in the form of DICOM-RT-Image.

This Siemens 510(k) submission for the Virtual Simulation (VSIM) Release 1.0 software does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a specific study proving the device meets those criteria. The provided document is a summary for regulatory clearance, primarily focused on demonstrating substantial equivalence to predicate devices, rather than a detailed technical report or performance study.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in this document. The focus is on functionality and equivalence to predicate devices, implying that if it functions similarly, it meets an unstated "acceptable" level of performance.
• Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision, processing speed benchmarks) are reported. The document describes the capabilities of the software rather than its measured performance against specific targets.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. This document does not detail any specific clinical or technical testing data.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. There is no mention of a formal ground truth establishment process or the use of experts for a test set in this summary.

4. Adjudication method for the test set:

• Not applicable/specified. No test set or adjudication method is detailed.

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

• No. This document describes a treatment planning software, not an AI-assisted diagnostic or interpretative tool. MRMC studies are not relevant to this type of device as described here. The software provides tools for the user, but its "intelligence" is not framed as an AI for diagnosis or interpretation that would improve human reader performance in a statistical sense.

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

• No. The device is explicitly described as a software application with a "human-in-the-loop" where the user performs actions like creating models, identifying isocenters, and placing beams. There's no mention of a standalone algorithm performance evaluation.

7. The type of ground truth used:

• Not applicable/specified for performance testing. The "ground truth" for radiation therapy planning is ultimately expert clinical judgment and treatment outcomes, but this document does not refer to using these for a formal validation study of the software itself. The output of VSim (structure sets, plans, DRRs) becomes input for further clinical processes.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set in the conventional sense. It's a software application providing tools for users.

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

• Not applicable, as there is no training set for this type of software.

In summary: The provided 510(k) summary for Siemens Virtual Simulation (VSIM) is a regulatory document focused on demonstrating equivalency to existing devices based on functional descriptions. It does not contain the detailed information about performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment that would be present in a comprehensive device performance study report. This kind of information is typically part of internal validation reports or more detailed technical documentation, not usually included in the high-level 510(k) submission summary.

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