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) and precision stereotactic applications. The stereotactic applications may include single-session radiosurgery, fractionated stereotactic radiation therapy, or fractionated stereotactic intensity modulated radiation therapy for lesions, tumors and conditions anywhere in the head and body where radiation therapy is indicated.

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, contains software applications 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 devices conforming to the DICOM Standard.

The syngo@RT Oncologist Workspace permits localization, contouring, segmentation, image calibration, and review of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

Device Description

The ARTISTE™ Solution SYS_VB50 Update to the ARTISTE family of medical linear accelerators is intend to update customers with optional new features and accessories for systems with the syngo® RT Therapist and RT Therapist Connect Workspaces (versions v4.1 or v4.2) for the ARTISTE systems. This update is intended to be backwards compatible to the currently cleared ONCOR and PRIMUS family of medical linear accelerators and their Control Consoles (v9.0+ and v11.0+), the RT Therapist (v2.1a or v2.2) and Oncologist v2.0 workspaces.

The technological characteristics of the RT Therapist Connect Workspace v4.2 and Control Console 12 remain unchanged from the currently cleared product (K102671).

The syngo® Suite for Oncology Workspace focused 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 syngo® products also include an array of image-oriented software tools, support for DICOM connectivity and the Siemens Remote Service option.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Siemens ARTISTE™ Solution with SYS_VB50 Update, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K103606) for the Siemens ARTISTE™ Solution with SYS_VB50 Update focuses on demonstrating substantial equivalence to predicate devices rather than providing specific, quantitative acceptance criteria and performance metrics for a novel claim.

Instead of a table with numerical acceptance criteria, the document states:

Aspect	Acceptance Criteria (Implicit)	Reported Device Performance
Performance and Functionality	All testable requirements in Engineering Requirements Specifications (ERS), Sub-System Requirements Specifications (SSRS), and Risk Management Hazard keys are met. Software verification and regression testing meet previously determined acceptance criteria in Test Plans.	Successfully verified and traced in accordance with Siemens product development process (PDP). Performed successfully to meet acceptance criteria.
System Level Validation	Software meets acceptance criteria as noted in system test plans.	System level validation and regression testing performed successfully.
Safety	Device does not introduce any new potential safety risks. Device adheres to recognized and established industry practice and relevant international standards to minimize electrical, mechanical, and radiation hazards.	Risk analysis used to identify potential hazards and mitigations; potential hazards controlled by software means, user instructions, verification of requirements, and validation of clinical workflow.
Intended Use	Maintains the same intended use as predicate devices.	The update does not change the intended use of the original syngo® RT Therapist or Oncologist Workspaces or the Siemens branded Linear Accelerator Systems.
Substantial Equivalence	Demonstrates substantial equivalence to predicate devices.	Claim of substantial equivalence to several predicate devices is supported by verification and validation testing.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical data used for performance evaluation, as this submission is primarily about software updates and feature additions for an existing device.

The "test set" for performance evaluation refers to production prototype devices and the testing was described as non-clinical test results which means it was not performed on human subjects.

Sample Size for Test Set: Not explicitly stated as a number of devices/patients. The testing was performed on "production prototype devices."
Data Provenance: Non-clinical (bench testing, system test level) rather than real-world patient data. The country of origin is Siemens Medical Solutions USA, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable/not stated. The ground truth for this type of non-clinical, software update validation is based on engineering specifications and adherence to design requirements, not expert clinical consensus on patient data.
Qualifications of Experts: The testing was carried out by "appropriately trained and knowledgeable test personnel." No specific professional qualifications (e.g., radiologist, medical physicist) are mentioned for these personnel in the context of establishing ground truth, as they are validating the software's adherence to its design specifications.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned as this was non-clinical technical validation against pre-defined engineering requirements and acceptance criteria, not a clinical trial with ambiguous cases requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and functional testing, not a direct comparison of human reader performance with and without AI assistance. This is a 510(k) for a software update to a radiation therapy system, not an AI-powered diagnostic device.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, standalone performance (algorithm only) was evaluated indirectly through the "Bench Testing" and "Non-Clinical Test Results" sections. These tests assess the software's functional performance against its requirements in an isolated manner, without direct human interaction as part of the core evaluation. The "algorithm" here refers to the software features and updates. The device itself (linear accelerator) operates with human-in-the-loop, but the validation of the software updates described here is akin to a standalone performance check against specifications.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Engineering Requirements Specifications (ERS), Sub-System Requirements Specifications (SSRS), and Risk Management Hazard keys: The software was tested to ensure it met these predefined technical and safety requirements.
Test Plans: Acceptance criteria outlined in test plans served as the ground truth for software verification and validation.

This is a technical ground truth, not clinical ground truth derived from pathology, expert consensus on patient images, or patient outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not stated. This 510(k) pertains to a software update (SYS_VB50) for an existing medical linear accelerator system, not a de novo AI/ML algorithm that requires a "training set" in the context of machine learning model development. The software is likely deterministic and rule-based, or uses pre-defined algorithms, rather than being "trained" on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not stated. As no training set for an AI/ML model is indicated, there is no discussion of how ground truth for such a set would be established. The "ground truth" for the device's technical functionality, as mentioned in point 7, is established through engineering design and safety specifications.

Summary

{0}------------------------------------------------

K103606

. .

ు

Siemens Medical Solutions USA, Inc. Oncology Care Systems

APR 15 2011

November 27, 2010

Section 5

510(k) Summary ::

Date Prepared: ·

Submitter: Siemens Medical Solutions USA, Inc. Oncology Care Systems 4040 Nelson Avenue . Concord, CA 94520

Contact: Christine Dünbar Senior Regulatory Affairs Specialist

Phone: (925) 602-8157 Fax: . (925) 602-8008 Email: christine.dunbar@siemens.com

Proprietary Name: ARTISTE™ Solution with SYS_VB50 Update

Medical Charged-Particle Radiation Therapy System Common Name:

Classification: 892.5050

Product Code: IYE

Substantial Equivalence Claimed To:

Product	510(k)Clearance/Date	Claim of Equivalence for:
syngo® RT TherapistConnect for RTTherapist version 4.2including ControlConsole 12.	K102671 /Oct. 12,2010	syngo® RT Therapist Connect v4.2 software updateSYS_VB50 and Control Console 12, and newlicensed features, In-Line kView™ and MultipleX™
ARTISTE™ Solution(aka ARTISTE MV)RTT v4.1 withMegaVoltage ConeBeam (MVCB) and theOPTIVUE Flat Panel,160MLC and electron	K072485 /Dec. 27,2007	ARTISTE™ Solution with the syngo® RT TherapistConnect v4.2 with software update SYS_VB50 andControl Console 12, with the new licensed featureIn-Line kView™ using the MVCB with a carbongraphite target, OPTIVUE 1000ART Flat Panel,160MLC and electron treatment cones and

. ..

510(k) for SIEMENS ARTISTE™ Solution with SYS_VB50 Update

Page Sect. 5/1

00023

{1}------------------------------------------------

Product	510(k)Clearance/Date	Claim of Equivalence for:
treatment cones andaccessoriesIncluding the RTTherapist Assist (off-line) Workspace		accessoriessyngo® RT Oncologist v4.2 including the RTTherapist Assist off-line features.
COHERENCE™Oncologist v2.0 withAdaptive Targeting and2D portal imageapproval.	K060633 /May 01,2006	syngo® RT Oncologist v4.2 with AdaptiveTargeting and 3D portal image approval.
syngo® DosimetristWorkspace v2.7including the Basic,Advance and Modelbased Segmentationfeatures.	K101119 /June 16,2010	syngo® RT Oncologist v4.2 with Basic, Advanceand Model based Segmentation features.
PreScision™ Option*	K082775 /Feb. 19,2009	ARTISTE™ Solution with the syngo® RT TherapistConnect v4.2 with software update SYS_VB50 andControl Console 12, and new licensed feature calledMultiple X™ and multiple high dose rate andUnFlat energy options.

The ARTISTETM Solution SYS VB50 Update as described in this premarket notification has the same intended use and fundamental scientific technical characteristics as the predicate devices listed above.

Description Summary - ARTISTE™ Solution with SYS_VB50 Update

Technological Characteristics:

The ARTISTE™ Solution SYS_VB50 Update to the ARTISTE family of medical linear

accelerators is intend to update customers with optional new features and accessories for systems with the syngo® RT Therapist and RT Therapist Connect Workspaces (versions v4.1 or v4.2) for the ARTISTE systems. This update is intended to be backwards compatible to the currently cleared ONCOR and PRIMUS family of medical linear accelerators and their Control Consoles (v9.0+ and v11.0+), the RT Therapist (v2.1a or v2.2) and Oncologist v2.0 workspaces.

The technological characteristics of the RT Therapist Connect Workspace v4.2 and Control Console 12 remain unchanged from the currently cleared product (K102671).

510(k) for SIEMENS ARTISTE™ Solution with SYS VB50 Update

{2}------------------------------------------------

The syngo® Software Architecture:

Refer to Section 11- 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.

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 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

510(k) for SIEMENS ARTISTE™ Solution with SYS VB50 Update

Page Sect. 5/3

{3}------------------------------------------------

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, contains software applications 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 devices conforming to the DICOM Standard.

The syngo® RT Oncologist Workspace v4.2 permits localization, contouring, segmentation, image calibration, and review of treatment plan parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

Substantial Equivalence:

The Substantial Equivalence comparison chart in Section 12 demonstrates the comparison of the technological characteristics of the new features and their currently cleared predicate devices.

The new features for the syngo® RTT Connect Workspace v4.2, the rebranding and updating of the syngo® RT Oncologist v4.2 and the modifications to the Linear Accelerator portal imaging system, does not change the intended use of the original syngo® RT Therapist or Oncologist Workspaces or the Siemens branded Linear Accelerator Systems.

Bench Testing:

Bench testing in the form of Unit, Sub-System Integration (SSIT), and System Integration (SIT) testing was performed to evaluate the performance and functionality of the new feature and software updates. All testable requirements in the Engineering Requirements Specifications (ERS) keys, Sub-System Requirements Specifications (SSRS) keys, and the Risk Management Hazard keys 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 new features for syngo® RT Therapist Connect Workspace, v4.2 and Oncologist v4.2 has been performed at the System test (ST) 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:

510(k) for SIEMENS ARTISTE™ Solution with SYS VB50 Update

Page Sect. 5/4

00026

{4}------------------------------------------------

The Siemens branded Linear Accelerators with the new features 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 new software features and component requirements for

In-Line kView™ imaging with the carbon graphite target and the OPTIVUE™ . 1000ART Flat Panel,
. the additional high dose rate Unflat energies in Multiple X™.
the syngo® RT Oncologist v4 with Adaptive Targeting, Advanced and Model ● Based Segmentation and 3D Image and plan review and approval,
. accessories such as Small cones, Rotational applicators,
and the OPTIGARD™ collision avoidance system, .
along with the validation of the intended use,

including the regression testing to the existing RT Therapist Connect software v4.2 and the Control Console 12 functional requirements, is intended to support the claim of substantial equivalence to the currently cleared:

syngo® RT Therapist Connect Workspace, v4.2(K102671), ●
the ARTISTE (K072485) medical linear accelerator with the RT Therapist and . RT Therapist Assist workspaces, electron cone accessories and a collision avoidance system.
and to the stereotactic option PreScision (K082775) for high dose rate, unflat energies.
additionally to the Advanced Segmentation and Model based Segmentation . features in the Dosimetrist v2.7 (K101119)
Image and plan review and approval and Adaptive Targeting in the Oncologist . v2.0 (K060633)

Summary:

. ·

In summary, it is SIEMENS' belief that the ARTISTE with the Sys VB50 update does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as the predicate devices.

Page Sect. 5/5

00027

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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. Oncology Care Systems 4040 Nelson Avenue CONCORD CA 94520

APR 1 5 2011

Re: K103606

Trade/Device Name: ARTISTE™ Solution with SYS VB50 Update Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 25, 2011 Received: March 28, 2011

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

{6}------------------------------------------------

Page 2

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.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Section 4

Indication For Use Statement

510(k) Number (if known): K (03606

Device Name: ARTISTE™ Solution with SYS VB50 Update

Indications for Use:

The syngo® Suite for Oncology Workspaces:

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

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

	(Division Sign-Off)
	Division of Radiological Devices
	Office of In Vitro Diagnostic Device Evaluation and Safety

510K	K113606
Prescription Use	✓
(Per 21 CFR 801.109)
	OR
	Over-the-Counter Use

510(k) for SIEMENS ARTISTE™ Solution with SYS VB50 Update

Page Sec 4/1

00022

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.