The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

The linear accelerator systems are high-dose and high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, turnors and conditions anywhere in the head and body where radiation therapy is indicated.

The syngo® RT Therapist workspace is a component of the linear accelerator system and is based on the syngo@ architecture. The syngo@ RT Therapist workspace contains software applications to support patient selection/setup, patient position, treatment delivery/verification. and treatment recording.

The syngo® RT Therapist Workspace v4.3.1, can be interfaced with third party devices conforming to the DICOM Standard.

Device Description

The syngo® RT Therapist Workspace v4.3.1 release is intended to update customers with the currently released syngo® RT Therapist Workspace software with version v4.3 for ARTISTE, ONCOR & PRIMUS Linear Accelerator systems. The technological characteristics and the fundamental technology of the syngo® RT Therapist Workspace v4.3.1 remain unchanged from the currently cleared products.

The syngo® RT Therapist software utilizes the proprietary syngo® software architecture design that provides a method of delivering customized software applications based on the modality as clinically supporting packages. SIEMENS utilizes, as part of the Oncology clinical focus package, multiple syngo® software applications for patient set-up and position verification, treatment localization, treatment verification, portal imaging as well as data processing, image reformatting, display and printing. The currently cleared syngo® based software products also includes an array of image-oriented software tools, support for DICOM connectivity, Siemens Remote Service [SRS], and virus protection features.

AI/ML Overview

The provided document K132935 describes the syngo® RT Therapist Workspace, v4.3.1. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria in the typical sense of performance metrics (like accuracy, sensitivity, specificity) for an AI/ML device.

This 510(k) submission is for an update to existing software that is a component of a medical linear accelerator system. The primary focus of the submission is to demonstrate substantial equivalence to previously cleared predicate devices and to show that the update does not introduce new safety risks or change the fundamental technological characteristics or intended use. The testing described is primarily focused on software verification, validation, and regression testing to ensure functionality and safety.

Therefore, many of the requested data points, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used for performance validation, and training set details, are not applicable or not present in this type of 510(k) submission for a software update to a control system.

Here's a breakdown of the information that is available or can be inferred, and where the requested information is absent:

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

Acceptance Criteria (Inferred from submission)	Reported Device Performance and Study Findings (from submission)
Functional Requirements: The syngo® RT Therapist Workspace, v4.3.1 (with Control Console 13) must perform its intended functions for patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.	Bench Testing Results:- Unit, Integration, and System Integration testing performed to evaluate performance and functionality.- All testable requirements in System Requirements Specifications (SRS) and Component Requirements (CRS) for Sys_VC10C project, and specific requirements for third-party OIS implementation, were successfully verified and traced.- Software verification and regression testing performed successfully to meet "previously determined acceptance criteria as stated in the Test Concept."Non-Clinical Test Results:- Validation of syngo® RT Therapist Workspace v4.3.1, optional third-party OIS implementation, and regression testing with Control Consoles 13 performed at the System test level.- System level validation and regression testing "performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans."
Safety: The update should not introduce any new potential safety risks.	Summary Statement: "In summary, it is SIEMENS' opinion that the syngo® RT Therapist Workspace update to v4.3.1 including the optional 3rd party OIS Connectivity system (ARIA OIS), does not introduce any new potential safety risks and is substantially equivalent to, and performs as well [as predicate devices]."
Compatibility/Interoperability: Interface with third-party devices conforming to the DICOM Standard and with specific OIS/V&R systems (ARIA, Varian Treatment, MOSAIQ, Sequencer).	Description: Explicitly states the device "can be interfaced with third party devices conforming to the DICOM Standard." The update directly addresses compatibility with specific OIS/V&R systems (e.g., ARIA, Varian Treatment). The validation activities would indirectly confirm this.
Compliance with Standards: Meet requirements for conformity to multiple industry standards.	Testing to Consensus Standards: "The syngo® RT Therapist Workspace v4.3.1 and the Control Console 13 supporting the third party OIS and V&R implementation have been tested to meet the requirements for conformity (where applicable) to multiple industry standards." (Details referred to Sections 9 and 17, which are not provided in the extracted text).
Substantial Equivalence: Maintain the same intended use and fundamental scientific and technical characteristics as predicate devices.	Substantial Equivalence Comparison: Claimed throughout the document. The general tone and purpose of a 510(k) is to demonstrate this. The FDA's clearance letter confirms their agreement with this claim.

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

Sample Size: Not specified. The testing described is software verification and validation, not a clinical study on patient data. It's likely related to testing various software functionalities and integrations.
Data Provenance: Not applicable, as it's not a data-driven AI/ML study.

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):

Number of Experts/Qualifications: Not specified. This type of information is usually relevant for performance studies on diagnostic or therapeutic output, not for a software control system update focused on functionality and safety. The "ground truth" here is the correct functioning of the software according to its specifications.

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

Adjudication Method: Not specified and likely not applicable in this context. Software validation typically involves pass/fail criteria for specific test cases determined by engineering specifications.

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:

MRMC Study: No. This is not an AI/ML device in the sense of providing diagnostic or interpretive outputs to human readers. It's a control system component.

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

Standalone Performance: Not applicable in the context of an AI/ML diagnostic or therapeutic algorithm. The software performs its functions as part of a larger medical device system. The "System level validation" described is essentially the standalone performance of the software component within its intended environment.

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

Type of Ground Truth: The "ground truth" for this type of software update is its adherence to engineering specifications, functional requirements, and safety standards. This is established through structured software verification and validation processes, not clinical reference standards like pathology or expert consensus on medical images.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is not described as an AI/ML system that learns from a training set of data. It's a deterministic software program.

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

Ground Truth for Training Set: Not applicable, as there is no described training set.

Summary

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K132935
Page 1 of 5

FEB 2 1 2014

Section 5 510(k) Summary

Date Prepared:		September 12, 2013
Submitter:		Siemens Medical Solutions USA, Inc.Radiation Oncology757A Arnold DriveMartinez, CA 94553
Contact:		Christine DunbarSenior Manager, Regulatory Affairs
Phone:Fax:Email:	(925)293-5442(925)602-8008christine dunbar@siemens.com
Proprietary Name:		syngo® RT Therapist Workspace, v4.3.1And the optional 30 party OIS Connectivity System
Common Name:		Accessory To; Medical Charged-Particle Radiation Therapy System
Classification:		892.5050
Product Code:		IYE

Substantial Equivalence Claimed To:

Product	510(k)Clearance / Date	Claim of Equivalence for:
COHERENCE™ RT TherapistConnect update to Sys_32A(RTTC v2.3) with ControlConsole 9.2.18 and 11.0.212supporting 3rd party OIS, V&Rcalled ARIA and VarianTreatment8 and third party TPSand PACs systems	K123812 /March 01, 2013	Syngo® RT Therapist with softwareversion 4.3.1, with Control Console v13,an update to Sys_VC10C supporting 3rdparty OIS, V&R called ARIA and VarianTreatment9 and third party TPS andPACs systems
ARTISTE™ Solution with SYS-VC10A for the syngo® RTTherapist (RTT v4.3, CC 13)supporting 3rd party OIS, V&R	K121295 / June12, 2012	Syngo® RT Therapist with softwareversion 4.3.1, with Control Console v13,an update to Sys_VC10C supporting 3rdparty OIS, V&R called ARIA and Varian

8 ARIA OIS and Varian Treatment V&R systems are manufactured by Varian Medical Systems. ARIA OIS and Varian Treatment Vart Systems are manufactured by Varian Medical Systems.
9 ARIA OIS and Varian Treatment V&R systems are manufactured by Varian Medical Systems.

510(k) for SIEMENS syngo® RT Therapist v4.3.x and 3rd Party OlS Section/ Page - 5/1

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called MOSAIQ and SequencerV&R10 and third party TPS andPACs systems.		Treatment11 and third party TPS andPACs systems
syngo® RT Therapist Connect(RTT v4.2, CC 12)(ARTISTE, ONCOR andPRIMUS Linacs) supporting 3rdparty OIS, V&R called MOSAIQand Sequencer V&R12 and thirdparty TPS and PACs systems	K103606 /April15, 2011	syngo® RT Therapist with softwareversion 4.3.1, with Control Console v13,an update to Sys_VC10C supporting 3rdparty OIS, V&R called ARIA and VarianTreatment13 and third party TPS andPACs systems.

The update to the syngo® RT Therapist Workspace, v4.3.1 as described in this premarket notification has the same intended use and fundamental scientific technical characteristics as the predicate devices listed above.

Description Summary

syngo® RT Therapist Workspace, v4.3.1

Technological Characteristics:

The syngo® RT Therapist Workspace v4.3.1 release is intended to update customers with the

currently released syngo® RT Therapist Workspace software with version v4.3 for ARTISTE, ONCOR & PRIMUS Linear Accelerator systems. The technological characteristics and the fundamental technology of the syngo® RT Therapist Workspace v4.3.1 remain unchanged from the currently cleared products.

The syngo® Software Architecture:

This update is intended to be backwards compatible to upgrade the currently cleared ONCOR and PRIMUS family of medical linear accelerators and their Control Consoles (v9.2+ & v11.0, v12), the COHERENCE™ RT Therapist (v2.3) workspace (K123812). Additionally, the ARTISTE

11 ARIA OIS and Varian Treatment V&R systems are manufactured by Varian Medical Systems.

12 MOSAIQ OIS and Sequencer V&R systems are manufactured by IMPAC Medical / Elekta AB.

13 ARIA OIS and Varian Treatment V&R systems are manufactured by Varian Medical Systems.

510(k) for SIEMENS syngo® RT Therapist v4.3.x and 3d Party OlS Section/ Page - 5/2

10 MOSAIQ OIS and Sequencer V&R systems are manufactured by IMPAC Medical / Elekta AB.

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Solution with the syngo® RTT v4.1x and v4.2x (K103606) can also be upgraded. These previous versions can be migrated to the current release (syngo® RTT. v4.3) and Control Console 13.

General Safety and Effectiveness:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by software means, user instructions, verification of requirements and validation of the clinical workflow to ensure that the product meets its intended uses. To minimize electrical, mechanical and radiation hazards, SIEMENS adheres to recognized and established industry practice and relevant international standards.

Refer to Section 21 for the Risk Management documentation.

Intended Use:

The intended use of the SIEMENS branded ARTISTE™ , ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

The linear accelerator systems are high-dose rate medical linear accelerators optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT), modulated arc therapy (mARC) and precision stereotactic radiation therapy for lesions, turnors and conditions anywhere in the head and body where radiation therapy is indicated.

The syngo® RT Therapist workspace is a component of the linear accelerator system and is based on the syngo® architecture. The syngo® RT Therapist workspace contains software applications to support patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.

The syngo® RT Therapist Workspace v4.3.1 can be interfaced with third party devices conforming to the DICOM Standard.

Substantial Equivalence:

The Substantial Equivalence comparison chart demonstrates the comparison of the technological characteristics of the synqo® RT Therapist Workspace update to the currently cleared predicate devices.

The syngo® RT Therapist Workspace v4.3.1 (project Sys_VC10C) does not change the intended use of the original ARTISTE™ Solution with the syngo® RT Therapist Workspace v4.3 (project Svs VC10A) or the previously cleared ONCOR™ or PRIMUS™ Siemens branded Linear Accelerator Systems.

Bench Testing:

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Bench testing in the form of Unit, Integration and System Integration testing was performed to evaluate the performance and functionality of the software update v4.3.1 for the RT Therapist and regression testing the Control Console version 13.

All testable requirements in the System Requirements Specifications (SRS) and Component Requirements (CRS) for the Sys_VC10C project, and additionally the specific requirements for the implementation of the third party OIS have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process (PDP).

The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria as stated in the Test Concept.

Non-Clinical Test Results:

Validation of the syngo® RT Therapist Workspace v4.3.1, implementation of the optional third party OIS and regression testing with Control Consoles 13 has been performed at the System test level on production prototype devices by appropriately trained and knowledgeable test personnel. System level validation and regression testing has been performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans.

Testing to Consensus Standards:

The syngo® RT Therapist Workspace v4.3.1 and the Control Console 13 supporting the third party OIS and V&R implementation have been tested to meet the requirements for conformity (where applicable) to multiple industry standards.

Refer to Sections 9 and 17 for this content.

Substantial Equivalence to Predicates:

The verification testing to the System requirements for the syngo® RT Therapist workspace, validation of the intended use, and the regression testing to the existing syngo® RT Therapist software and Control Console functional requirements, is intended to support the claim of substantial equivalence to the following predicates:

The COHERENCE™ RT Therapist Connect v2.3 with Control Consoles 9.2.18 and . 11.0.212 supporting 3d party OIS & V&R (ARIA and Varian Treatment™ System) and third party TPS and PACs systems (K123812).
The ARTISTE™ Solution with SYS-VC10A for the syngo® RT Therapist (RTT v4.3, . CC 13) supporting 310 party OIS & V&R (MOSAIQ and Sequencer V&R15) and third party TPS and PACs systems. (K121295).
The syngo® RT Therapist Connect (RTT v4.2, CC 12) (ARTISTE, ONCOR and . PRIMUS Linacs) supporting 30 party OIS & V&R (MOSAIQ and Sequencer V&R10) and third party TPS and PACs systems (K103606).

14 ARIA OIS and Varian Treatment V&R systems are manufactured by Varian Medical Systems.

15 MOSAIQ OIS and Sequencer V&R systems are manufactured by IMPAC Medical / Elekta AB.

16 MOSAIQ OIS and Sequencer V&R systems are manufactured by IMPAC Medical / Elekta AB.

510(k) for SIEMENS syngo® RT Therapist v4.3.x and 3rd Party OIS Section/ Page - 5/4

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K132935
page 5 of 5

Summary:

In summary, it is SIEMENS' opinion that the syngo® RT Therapist Workspace update to v4.3.1 including the optional 3" party OIS Connectivity system (ARIA OIS), does not introduce any new
potential safety risks and is substantially equivalent to, and performs as well devices.

....

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a three-barred cross, which is the symbol of the Public Health Service.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 21, 2014

SIEMENS MEDICAL SOLUTIONS USA, INC. % CHRISTINE DUNBAR SENIOR MANAGER, REGULATORY AFFAIRS 757A ARNOLD DRIVE MARTINEZ CA 94553

Re: K132935

Trade/Device Name: syngo® RT Therapist Workspace, v4.3.1 & optional 3d party OIS Connectivity System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 4, 2013 Received: October 7, 2013

Dear Ms. Dunbar:

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, Drug, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Dunbar

and the country of the states a

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jaming Jr. Marge

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

ndications for Use

510(k) Number (if known) K132935

Device Name

syngo RT Therapist Workspace, v4.3.1

Indications for Use (Describe)

The syngo® RT Therapist Workspace v4.3.1, can be interfaced with third party devices conforming to the DICOM Standard.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'HaraFORM FDA 3881 (1/14)

PSC Publishing Sen sees (30) ) 441-47 an E

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

... . . . . . . . . "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.