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 syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The syngo® RT Therapist Connect Workspace, v4.2, is an additional option when third party OIS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace, v4.2 is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace can be interfaced with third party devices conforming to the DICOM Standard.

The addition of the syngo® RT Therapist Connect Workspace, v4.2, does not change the intended use of the Siemens branded Linear Accelerator System.

Device Description

The syngo® RT Therapist Connect Workspace v4.2 release is intend to update customers with the syngo® RT Therapist Connect Workspace with versions v4.1 (ARTISTE systems) and v2.1a (ONCOR / PRIMUS systems). The technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 remain unchanged from the currently cleared product.

The syngo® RT Therapist Connect software utilizes the proprietary syngo® software architecture design provides a method of delivering customized software applications based on the modality as clinically supporting packages. From these applications SIEMENS utilizes, as part of the Oncology clinical focus package, multiple 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 COHERENCE™ and synqo® products also include an array of image-oriented software tools, support for DICOM connectivity and Siemens Remote Service.

AI/ML Overview

This Siemens product, syngo® RT Therapist Connect Workspace, v4.2, is a software update for an existing medical device, not a new AI-based diagnostic tool. The document describes a traditional software update verification and validation process, not a clinical study to evaluate device performance against specific acceptance criteria in terms of accuracy, sensitivity, or specificity.

Therefore, many of the requested elements (like sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for training/testing) are not applicable in the context of this submission. The "acceptance criteria" here refer to successful completion of software testing against defined requirements, not clinical performance metrics.

Here's a breakdown of the available and relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested for)	Reported Device Performance (Outcome)
All testable requirements in the Software Requirements Specifications (SRS), Sub-System Requirements Specifications (SSRS), and Functional Specifications (FS) for the Control Console software and Function Controller firmware.	Successfully verified and traced in accordance with the Siemens product development (lifecycle) process (PDP). All testable requirements met.
Software verification and regression testing.	Performed successfully to meet their previously determined acceptance criteria as stated in the Test Plans.
System level validation and regression testing (on production prototype devices).	Performed successfully, demonstrating that the software meets the acceptance criteria as noted in the system test plans.
Conformity to relevant consensus standards: IEC 60601-1-4:1996+ A1: 1999 (Medical Electrical Equipment: Part 1-4: Collateral Standard: Programmable Electrical Medical Systems) and IEC 62304:2006 (Medical Device Software -- Software Life Cycle Processes).	Tested to meet the requirements for conformity (where applicable) to these standards.
No new potential safety risks introduced by the update.	Belief that the update does not introduce any new potential safety risks and performs as well as predicate devices.
Substantial equivalence to predicate devices (syngo® RT Therapist Connect Workspace, v4.1 and v2.1a (K090683); Control Consoles for ARTISTE (K072485) and ONCOR (K060226)).	Supported by verification testing, validation of intended use, and regression testing. FDA determined the device is substantially equivalent.

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

Sample Size: Not applicable in the context of a clinical test set. The document refers to "testable requirements" and "system test plans," which would involve software modules and system functionalities, not medical images or patient data in a statistical sample.
Data Provenance: Not applicable. This refers to software verification and validation, not analysis of medical data.

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

Number of Experts: Not applicable. Ground truth for a clinical diagnosis or measurement is not relevant to a software update’s functional and performance testing.
Qualifications of Experts: The testing was performed by "appropriately trained and knowledgeable test personnel." Their specific qualifications are not detailed beyond this.

4. Adjudication method for the test set

Adjudication Method: Not applicable. This type of formal adjudication process is not used for software functional and performance testing.

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 a software update for a radiation therapy system, not an AI-assisted diagnostic device. The functionality described (patient selection/setup, positioning verification, treatment delivery/verification, recording) is primarily for operational support in a radiation therapy workflow.

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

Standalone Performance: Not explicitly discussed in terms of an "algorithm only" performance study. The testing described is against software requirements and system functionality, which implicitly assesses the algorithm's performance within the system context. The device itself is a software application designed to be used in conjunction with linear accelerator systems, implying human interaction.

7. The type of ground truth used

Type of Ground Truth: For this type of software update, the "ground truth" would be the defined and documented software requirements (SRS, SSRS, FS) and expected system behaviors. Successful completion of tests against these requirements indicates that the software performs as specified.

8. The sample size for the training set

Sample Size: Not applicable. This is a software update, not a machine learning model that requires a training set of data.

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

Ground Truth Establishment: Not applicable. This device does not involve a training set as it's not an AI/ML model being developed.

Summary

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Siemens Medical Solutions USA, Inc. Oncology Care Systems

Section 5

OCT 1 8 2010

510(k) Summary

Date Prepared:

...

September 09, 2010

Submitter:	Siemens Medical Solutions USA, Inc.Oncology Care Systems4040 Nelson AvenueConcord, CA 94520
Contact:	Christine DunbarSenior Regulatory Affairs Specialist
Phone:	(925)602-8157
Fax:	(925)602-8008
Email:	christine.dunbar@siemens.com
Proprietary Name:	syngo® RT Therapist Connect Workspace, v4.2
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:
syngo® RT TherapistConnect Workspace withRT Therapist version VA20	K090683 /May 08,2009	syngo® RT Therapist Connect Workspace, for RTTherapist with Software update VB10 (RTTC v4.2)
ARTISTETM Solution (akaARTISTE MV) with ControlConsole 11.0	K072485 /Dec. 27,2007	syngo® RT Therapist Connect Workspace for RTTherapist with Software update VB10 (RTTC v4.2) andControl Console 12
ONCORTM Expression withControl Console 9.0	K060226 /Mar. 15,2006	syngo® RT Therapist Connect Workspace for RTTherapist with Software update VB10 (RTTC v4.2) andControl Console 12

The update to the syngo® RT Therapist Connect Workspace, v4.2 as described in this premarket notification has the same intended use and fundamental scientific technical characteristics as the predicate devices listed above.

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Description Summary

syngo® RT Therapist Connect Workspace, v4.2:

Technological Characteristics:

Zhe syngo® RT Therapist Connect Workspace v4.2 release is intend to update customers with

the syngo® RT Therapist Connect Workspace with versions v4.1 (ARTISTE systems) and v2.1a (ONCOR / PRIMUS systems). The technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 remain unchanged from the currently cleared product.

The syngo® Software Architecture:

Refer to Section 11- Design Description, for the Product and Sub-System Requirements Specifications regarding these specific requirements.

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.

Intended Use:

The syngo® Suite for Oncology Workspaces:

The syngo® workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The

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workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The syngo® RT Therapist Connect Workspace v4.2, is an additional option when third party OlS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace v4.2, is a software application that permits patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The syngo® RT Therapist Connect Workspace v4.2, can be interfaced with third party OIS, TPS and other validated devices conforming to the DICOM Standard.

Substantial Equivalence:

The Substantial Equivalence comparison chart in Section 12 demonstrates the comparison of the technological characteristics of the syngo® RT Therapist Connect Workspace v4.2 and Control Console 12 update to the currently cleared predicate devices.

The syngo® RT Therapist Connect Workspace v4.2, does not change the intended use of the original syngo® RT Therapist Connect Workspace or the Siemens branded Linear Accelerator Systems.

Bench Testing:

Bench testing in the form of Unit. Integration and System Integration testing was performed to evaluate the performance and functionality of the software update for the RT Therapist Connect and the Control Console, version 12. All testable requirements in the Software Requirements Specifications (SRS), Sub-System Requirements Specifications (SSRS), and specifically, the Functional Specifications (FS) for the Control Console software and Function Controller firmware, 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 Plans.

Non-Clinical Test Results:

Validation of the syngo® RT Therapist Connect Workspace, v4.2 and Control Console 12 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 Connect Workspace, v4.2, Control Console and firmware have been tested to meet the requirements for conformity (where applicable) to the following standards:

IEC 60601-1-4:1996+ A1: 1999 Medical Electrical Equipment: Part 1-4: General . requirements for Collateral Standard: Programmable Electrical Medical Systems
IEC 62304:2006 Medical Device Software -- Software Life Cycle Processes .

510(k) for SIEMENS syngo® RT Therapist Connect Update

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Substantial Equivalence to Predicates:

The verification testing to the software and component requirements (Control Console), validation of the intended use, and the regression testing to the existing RT Therapist Connect software and Control Console functional requirements, is intended to support the claim of substantial equivalence to the currently cleared syngo® RT Therapist Connect Workspace, v4.1 and v2.1a. (K090683), the currently cleared Control Consoles and Function controllers for the ARTISTE (K072485) and ONCOR (K060226) medical linear accelerators.

Summary:

In summary, it is SIEMENS' belief that the syngo® RT Therapist Connect Workspace v4.2 update and the Control Console version 12 do not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

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Public Health Service

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Ms. Christine Dunbar Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 4040 Nelson Avenue CONCORD CA 94520

K102671 Re:

Trade Name: syngo® RT Therapist Connect Workspace, v4.2 Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 09, 2010 OCT 12 2010 Received: September 16, 2010

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Siemens Medical Solutions USA, Inc. Oncology Care Systems

Section 4 Indication For Use Statement

510(k) Number (if known): __

K102671

Device Name: syngo® RT Therapist Connect Workspace, v4.2

Indications for Use:

The syngo® Suite for Oncology Workspaces:

The addition of the syngo® RT Therapist Connect Workspace, v4.2, does not change the intended use of the Siemens branded Linear Accelerator System.

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

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	Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Prescription Use(Per 21 CFR 801.109)	Over-the-Counter UseOR(Division Sign-Off)Division of Radiological Devices
	Office of In Vitro Diagnostic Device Evaluation and SafetyK1026
	510(k) for SIEMENS syngo® RT Therapist Connect Update	Page Sec 4/1
	00032

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.