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

Device Description

The syngo® Therapist Connect Workspace is an optional feature to the existing SIEMENS branded ARTISTE™ and ONCOR™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC control console and the linear accelerator treatment delivery, dosimetry, treatment recording and portal imaging subsystems remain unchanged.

The syngo® Therapist Connect Workspace differs from the predicate COHERENCE and syngo® Therapist Workspaces in that it does not contain a Oncology Information System (OIS) or Verify and Record (V&R) application such as PRIMEVIEW. These functions are located on the Third Party OIS system. The syngo® Therapist Connect Workspace receives the treatment plan from a Third Party OIS system or Third Party Treatment Planning System (TPS), supports the final review of the treatment parameters and enables the Radiation Therapist to initiate the delivery of the treatment prescription.

Upon completion of the treatment prescription, a report is submitted to the Third Party OIS or TPS system in the form of a DICOM RT Structured Report. All other features such as patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording that are supported by the predicate COHERENCE and syngo® Therapist Workspaces remain unchanged.

AI/ML Overview

The provided text describes the "syngo® RT Therapist Connect Workspace" and its 510(k) submission to the FDA. However, it does not include detailed information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

The document primarily focuses on:

Description of the Device: What it is, its purpose, and how it differs from predicate devices (it doesn't include a proprietary Verify & Record application, relying on third-party OIS).
Intended Use and Indications for Use: Its role as an accessory to linear accelerator systems for radiation therapy.
Safety and Effectiveness: General statements about risk management, adherence to industry standards, and the belief that it introduces no new safety risks and is substantially equivalent to predicate devices.
Verification and Validation Testing: A very high-level statement that "Verification and Validation testing was performed to evaluate the performance and functionality of the syngo® RT Therapist Connect workspace software. This testing included software unit-level test, integration and system-level tests. The results demonstrate that the device satisfies all performance and functional requirements as stated in the Product Requirement Specifications."

Therefore, the specific information requested in your prompt (acceptance criteria table, detailed study information, sample sizes, expert qualifications, etc.) is not present in the provided text.

The text states that "The results demonstrate that the device satisfies all performance and functional requirements as stated in the Product Requirement Specifications," but it does not list these specifications or the raw performance results.

To answer your request based only on the provided text, I must state that this information is not available.

Here's what I can extract/infer from the text regarding your questions:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. The document generically mentions "all performance and functional requirements as stated in the Product Requirement Specifications" but these specifications are not provided.
- Reported Device Performance: No specific performance metrics (e.g., accuracy, speed, uptime) are reported in the provided text.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
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):
- Not mentioned. The device is a software workspace for managing radiation therapy, not typically one that requires expert-established ground truth in the way an AI diagnostic algorithm would.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not mentioned. Adjudication methods are typically relevant for diagnostic or image interpretation studies, which this is not.
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:
- Not done, as this device is a workflow management system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The testing performed ("software unit-level test, integration and system-level tests") would be considered "standalone" in the sense that they evaluated the software's inherent functionality. However, the performance metrics are not given. The device itself is human-in-the-loop by design as it assists a Radiation Therapist.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense for this type of device. "Ground truth" for this system would be conformance to its own "Product Requirement Specifications" and proper functionality of its features (patient selection/setup, positioning verification, treatment delivery/verification, recording, and DICOM interfacing). This is verified through software testing against those specifications.
The sample size for the training set:
- Not applicable as this is not an AI/machine learning device that requires a training set. It is a software application designed to manage workflow.
How the ground truth for the training set was established:
- Not applicable (see point 8).

Summary

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SIEMENS

MAY - 8 2009

510(k) Summary of Safety and Effectiveness

SIEMENS Medical Solutions USA, Inc

syngo® RT Therapist Connect Workspace

Submitted By	Siemens Medical Solutions USA, Inc.Oncology Care Systems4040 Nelson AvenueConcord, CA 94520
Contact Person	Christine DunbarSenior Regulatory Affairs SpecialistTel: (925) 602-8157Fax: (925) 602-8008Christine.dunbar.ext@siemens.com
Date Prepared	March 11, 2009
Proprietary Name	syngo® RT Therapist Connect
Common Name(s)	(Accessory To) Medical Charged-Particle Radiation Therapy System
Classification Name(s)	21 CFR, Part 892.5050 (90IYE)
Predicate Device	The syngo® RT Therapist Connect is substantially equivalent to thefollowing devices:

Product	510(k)	Clearance Date
ARTISTE™ Solution (akaARTISTE MV) with thesyngo® RT Therapistworkspace	K072485	December 27,2007
ONCOR™ Expression withCOHERENCE™ RT Therapistworkspace	K060226	March 15,2006
PreScision™ Option	K082775	February 19,2009

Siemens Medical Solutions USA, Inc. Oncology Care Systems Group syngo® AT Therapist Connect 510(k) Submission

CONFIDENTIAL

001172

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SIEMENS

Description Summary

Within the submission the following internal naming conventions are used:

Market Name	Internal naming convention
ARTISTE™	ARTISTE™ linear accelerator and ACCEL release 4+
Bay Bridge	Internal project name for the syngo® Therapist ConnectWorkspace.
ONCOR™ Expression	ONCOR™ linear accelerator and ACCEL release 2+
PRIMUS™	PRIMUS™ linear accelerator and ACCEL release 2+
PRIMEVIEW™	Siemens proprietary verify and record system. The syngo® basedPRIMEVIEW is hosted on the COHERENCE™ and the re-branded syngo® Therapist Workspace.The syngo base version is marketed as PRIMEVIEW3i and is usedon the PRIMUS™ linear accelerator systems.
COHERENCE™ Therapist Workspace	RTT Workspace contains the SIEMENS proprietary verify andrecord system as well as access to the Oncology InformationSystem and directly connects to the LINAC control console.
syngo® RT Therapist Workspace andsyngo® RT Therapist Express™	RTT Workspace contains the SIEMENS proprietary verify andrecord system as well as access to the Oncology InformationSystem and directly connects to the LINAC control console on theARTISTE™ linear accelerator system.
syngo® Therapist Connect Workspace	The syngo® Therapist Connect Workspace does NOT contain thePRIMEVIEW verify and record application. The Third Party OISsystem containing a verify and record application connects to thesyngo® Therapist Connect Workspace via a validated DICOMinterface.The syngo® Therapist Connect Workspace directly connects to theLINAC control console on the ARTISTE™ linear acceleratorsystem.
syngo® Suite for OncologyWorkspaces	Syngo based workstation, re-branded COHERENCE workspaces.
syngo®	Siemens proprietary software architecture and hosting SIEMENSsoftware applications organized by task cards on a dedicatedworkstation

For further definitions of the terms used in this submission, refer to the Glossary.

Technological Characteristics:

Siemens Medical Solutions USA, Inc. CONFIDENTIAL Oncology Care Systems Group syngo® RT Therapist Connect 510(k) Submission

Page 92 of 100

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2x Required: The Linear Accelerator device and its accessories are intended to be used by trained medical professionals under the supervision and direction of a therapeutic radiologist.

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 development. verification of requirements and validation testing. 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® RT Therapist Connect Workspace is an additional option when third party OIS, Treatment Planning Systems and/or PACS devices are intended to be used in conjunction CONFIDENTIAL Siemens Medical Solutions USA, Inc. Page 93 of 100 Oncology Care Systems Group syngo@ RT Therapist Connect 510(k) Submission

001174

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SIEMENS

with the Siemens branded Linear Accelerator system. The syngo® RT Therapist Connect Workspace 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 does not change the intended use of the Siemens branded Linear Accelerator System.

Verification and Validation Testing

Verification and Validation testing was performed to evaluate the performance and functionality of the syngo® RT Therapist Connect workspace software. This testing included software unit-level test, integration and system-level tests. The results demonstrate that the device satisfies all performance and functional requirements as stated in the Product Reguirement Specifications.

Summary:

In summary, it is SIEMENS' belief that the syngo® RT Therapist Connect workspace option does not introduce any new potential safety risks and is substantially equivalent to. and performs as well as, the predicate devices.

CONFIDENTIAL

001175

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and recognizable, representing the department's role in public health and welfare.

Public Health Service

MAY - 8 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090683

Trade/Device Name: syngo® RT Therapist Connect Workplace Regulation Number: 21 CFR 892.5050

Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 9, 2009

Received: April 10, 2009

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 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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx (Gastroenterology/Renal/Urology) (240) 276-0115 21 CFR 884.xxx (Obstetrics) Gynecology) (240) 276-0115 21 CFR 892.xxx (Radiology) (240) 276-0120 Other (240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Samme M. Marre

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SIEME

Indications for Use Statement

510(k) Number:

K0.90683

Device Name:

syngo® RT Therapist Connect Workspace

Indications for Use:

The syngo® Suite for Oncology Workspaces:

The syngo® RT Therapist Connect Workspace:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colin Pollard

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Prescription Use

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

Siemens Medical Solutions USA, Inc. Oncology Care Systems Group syngo® RT Therapist Connect 510(k) Submission

CONFIDENTIAL

Over-The-Counter Use

Page 1 of _1 : Page 86 of 100

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AND/ OR

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.