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.

Device Description

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:

Structure sets stored in the form of DICOM-RT Structure-Set,
Reference Points (including isocenters) stored in the form of DICOM-RT Structure-Set.
Plans, including beams stored in the form of DICOM-RT-Plan, and
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.

AI/ML Overview

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.

Acceptance Criteria (Inferred/Missing)	Reported Device Performance (Operational Capabilities described)
Accuracy of 3D Model Creation	User can create 3D models of targets and organs.
Accuracy of Isocenter Identification	User can identify patient isocenter.
Accuracy of Beam Placement	User can place treatment beams.
Accuracy of Beam Modifier Identification	User can identify beam modifiers (blocks, apertures, MLCs).
Data Output Format Compliance	Creates DICOM-RT Structure-Set, DICOM-RT-Plan, DICOM-RT-Image.
Interoperability with other systems	Information sent to radiation treatment planning system; plans reviewed/approved prior to transfer to delivery system.
Compatibility with Scanners/Accelerators	Supports most popular CT Scanners and three most common linear accelerators (Siemens, Varian, Philips/Elekta).

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.

Summary

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5 2002 NOV

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K022036

510(k) Summary

Submitter:	Siemens Medical Solutions USA, Inc.Oncology Care Systems Group4040 Nelson AvenueConcord, CA 94520
Contact person:	Sean M. Curry16787 Bernardo Center Drive, Suite ASan Diego, CA 92128
Phone:	(858) 675-8200
FAX:	(858) 675-8201
Proprietary name:	Siemens Virtual Simulation (VSIM)
Common name:	Treatment Planning System
Classification:	892.5050
Product Code:	MUJ
Classification name:	System Planning Radiation Therapy Treatmen

Substantial equivalence claimed to:

K013112, FocalSim, Computerized Medical Systems, Inc. K923851 , ACQSIM, Philips Medical Systems(Cleveland), Inc.

Description:

Siemens Medical Solutions USA, Inc.

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SIEMENS

The VSim software will be used in a typical scenario summarized below:

Patient is registered, and the relevant data is entered into the system, ı
Schedule is created for radiation therapy, I
Patient is called in for a CT scan,
CT scan is performed, 트
VSim is used for initial viewing and definition of isocenter reference (for patient I marking)
트 Patient is marked prior to leaving the CT room,
트 VSim is used to delineate the Structures targeted for radiation and other critical Structures.
. VSim is used to establish a reference point, known as the isocenter reference, which will be marked on the patient, and any other coordinates will be based on this reference coordinate,
트 VSim is used to design the beam geometry,
. VSim is used to place the jaws and to define the blocks and/or MLC,
트 VSim is used to print charts used for flow of information,
트 VSim is used to print images on film,
t The plans are transferred to radiation therapy planning station for dose calculation.
l The isocenters may be changed by the dosimetrist,
. The plans may be transferred back to the VSim workstation for verification.

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,
1. Reference Points (including isocenters) stored in the form of DICOM-RT Structure-Set.
1. Plans, including beams stored in the form of DICOM-RT-Plan, and
1. 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.

Intended use:

The SYNGO workstation, K010938, 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.

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 Multi-Leaf Collimators (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 Medical Solutions USA, Inc.

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SIEMENS

Summary of technological characteristics Compared to Predicate Devices:

The VSim software described in this 510(k) will be an add-on to the SYNGO workstation, K010938. The VSim system incorporates no technological characteristics not currently in the predicate simulation devices. VSim supports the most popular CT Scanners as well as the three most common linear accelerators (Siemens, Varian, and Philips/Elekta)

Siemens Medical Solutions USA, Inc.

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Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the right. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH &" is arranged in a circular fashion. The bird symbol is composed of three curved lines that suggest the shape of a bird in flight.

5 2002 NOV

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens Medical Solutions USA. Inc. % Mr. Sean M. Curry Chief Operating Officer Certified Software Solutions, Inc. 16787 Bernardo Center Drive Suite A SAN DIEGO CA 92128

Re: K022036

Trade/Device Name: Siemens Virtual Simulation (VSIM) Release 1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: October 18, 2002 Received: October 21. 2002

Dear Mr. Curry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Henry C. Snodgin

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

K022036

Device Name: Siemens Virtual Simulation (VSIM)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use (Per 21 CER 801.109)

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.