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 is a high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treatments, fractionated intensity modulated radiation therapy (IMRT) for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multi-leaf collimator that is marketed as 160MLC™. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485).

The syngo® Suite for Oncology 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.

Device Description

The 160MLC™ Option is an integral feature of the currently cleared SIEMENS ARTISTE™ system and is intended to be marketed as an optional upgrade to the ONCOR™ Klystron class family of medical linear accelerator devices. The basic design, safety features and function of the 160-leaf Multi-Leaf Collimator and the ONCOR Linear Accelerator remain unchanged from their currently cleared intended use and functions. The 160MLC™ supports the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation using the conventional linear accelerator. The 160MLC, in conjunction with the Linear Accelerator and control systems, arrough to delivery of X-Ray photon or electron energy for precise treatment of lesions, turnors and onditions anywhere in the body where radiation therapy is indicated.

The 160MLC™ option supports the dynamic IMRT and dynamic Arc delivery of up to 1,000 (± 2%) MU / Minute X-Ray photon beam using a calibrated MV photon energy spectrum with an edge position acouracy at isocenter of 0.5mm (± 0.5mm) with minimal leakage and penumbra.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Siemens 160MLC™ Option, an accessory for linear accelerators used in radiation therapy. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way that would typically be presented for an AI/ML medical device.

Instead, this submission is centered on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the 160MLC™ Option's basic design, safety features, and function remain unchanged from already approved components. It focuses on the technological characteristics and intended use being similar to existing cleared devices.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or not provided in this specific type of regulatory submission, as it's not a study demonstrating AI/ML performance.

However, I can extract what is provided regarding performance claims and the general approach to safety and effectiveness.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are not quantitative performance metrics in the typical sense for an AI/ML device but rather technical specifications and aspects deemed important for safe and effective use.

Acceptance Criteria / Technical Specification (from document)	Reported Device Performance (from document)
Maximum X-Ray Photon Beam MU / Minute	Up to 1,000 (± 2%) MU / Minute
Edge Position Accuracy at Isocenter	0.5mm (± 0.5mm)
Leakage and Penumbra	Minimal
Basic Design, Safety Features, and Function	Unchanged from their currently cleared intended use and functions (referring to the 160-leaf Multi-Leaf Collimator and the ONCOR Linear Accelerator).
Potential Safety Risks	No new potential safety risks introduced by the addition of the 160MLC™ option to ONCOR linear accelerators.
Substantial Equivalence	Substantially equivalent to, and performs as well as, the predicate devices (SIEMENS ARTISTE™ (K072485), SIEMENS ONCOR™ Expression (K060226), SIEMENS PreScision™ Option (K082775), and the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485)).

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

Not applicable/provided. This is a technical device submission, not a study evaluating an AI/ML algorithm's performance on a dataset. The "test set" would refer to internal verification and validation of the device's physical and software components during development, which is summarized as adhering to industry practices and relevant international standards.

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

Not applicable/provided. "Ground truth" in this context would implicitly be derived from established physics principles of radiation therapy, engineering specifications, and clinical requirements rather than expert annotation of data for an AI/ML model.

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

Not applicable/provided. Adjudication methods are typically for resolving discrepancies in expert annotations for AI/ML ground truth.

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

Not applicable/provided. This submission is for a hardware accessory (Multi-Leaf Collimator) and associated software, not an AI-assisted diagnostic or treatment planning tool that would undergo an MRMC study.

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

Not applicable/provided. The "160MLC™ Option" is an integral part of a larger medical linear accelerator system, designed to operate in conjunction with clinical users and other system components. It's not a standalone AI algorithm.

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

The "ground truth" for the performance of the 160MLC™ Option, in a general sense, would be based on:

Physical measurements and engineering specifications: For parameters like edge position accuracy, leakage, and penumbra, which are quantifiable physical properties.
Compliance with established standards: Adherence to recognized and established industry practices and relevant international standards (as stated in the "General Safety and Effectiveness" section).
Clinical effectiveness of predicate devices: The claim of substantial equivalence relies on the known safe and effective performance of the predicate linear accelerator systems and MLCs.

8. The sample size for the training set

Not applicable/provided. This is not an AI/ML device that requires a training set in the typical sense.

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

Not applicable/provided (as above).

Summary

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K692145

SEP 1 8 2009

Siemens Medical Solutions USA, Inc. Oncology Care Systems

Section 5 510(k) Summary

Submitter:	Siemens Medical Solutions USA, Inc.Oncology Care Systems4040 Nelson AvenueConcord, CA 94520
Contact:	Christine DunbarSenior Regulatory Affairs Specialist
Phone:Fax:Email:	(925)602-8157(925)602-8008christine.dunbar.ext@siemens.com
Proprietary Name:	160MLC™ Option
Common Name:		An accessory to: Accelerator, Linear, Medical
Classification:	892.5050
Product Code:	IYE

Substantial Equivalence Claimed To:

PRODUCT	Clearance	Claim of Equivalence For:
SIEMENS ARTISTE™	K072485	The Siemens branded Linear Accelerator with the 160leaf MLC and the syngo® Suite for OncologyWorkspaces including the syngo® RT Therapist and RTTherapist Express.
SIEMENS ONCOR™Expression	K060226	ONCOR™ linear accelerator families and COHERENCEWorkspaces (or the re-branded syngo® Suite forOncology Workspaces), RT Therapist workspace withthe PRIMEVIEW V&R system, the 82 leaf MLC marketedas OPTIFOCUS™, the Flat Panel device marketed asthe OPTIVUE™ and the Mega-Voltage Cone Beamtechnology marketed as MVision™ and AdaptiveTargeting™.
SIEMENS PreScision™Option	K082775	Establishes the basic hardware/firmware and softwarecomponents across all of Siemens branded LinearAccelerators for the purposes SE and conformity tostandards testing at the device level. Indicates commonfeatures between Siemens branded Linear Acceleratorsfor interchangeability of device accessories and options.Supports increased dose rate and Enhanced StereotacticTechnique (EST) for the delivery of high precisionradiation therapy when used with an 82 leaf, 160 leaf orThird Party Multi-Leaf Collimators or stereotacticaccessories.

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510(k) for SIEMENS 160MLCTM Option

:有

ﺳﺘﺴ

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Slemens Medical Solutions USA, Inc. Oncology Care Systems

The ARTISTE™ and ONCOR™ family of linear accelerators with the 160MLC™ Option as described in this premarket notification has similar intended use and fundamental scientific technical characteristics as the predicate devices listed above.

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.x+
ONCOR™ Expression	ONCOR™ linear accelerator and ACCEL release 2.x+
ONCOR™ Avant-Garde	ONCOR™ linear accelerator and ACCEL release 1.x+ and 2.x+
PRIMEVIEW™	Siemens proprietary verify and record system. The syngo®basedPRIMEVIEW is hosted on the COHERENCE™ TherapistWorkspace.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.
MVCB - MVision™	Mega-Voltage Cone Beam - a method of obtalning 3 dimensionaldata for portal imaging.
160 MLC™	160-leaf multi-leaf collimator
OPTIFOCUS™	82-leaf multi-leaf collimator
58 MLC	58 leaf multi-leaf collimator
OPTIVUE™	aSi flat panel electronic portal imaging device (EPID) AL7 model
OPTIVUE 1000ST	aSi flat panel electronic portal imaging device (EPID) AG9 model
syngo® Therapist Workspace,RTT 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® 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.
Sys_VB35	System Software, version VB35 for ONCOR R2.2.

For further definitions of the terms used in this submission, refer to the Glossary in Section 24.

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510(k) for SIEMENS 160MLC™ Option

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Siemens Medical Solutions USA, Inc. Oncology Care Systems

Technological Characteristics:

The 160MLC™ Option:

The 160MLC™ Option is an integral feature of the currently cleared SIEMENS ARTISTE™ system and is

intended to be marketed as an optional upgrade to the ONCOR™ Klystron class family of medical linear accelerator devices. The basic design, safety features and function of the 160-leaf Multi-Leaf Collimator and the ONCOR Linear Accelerator remain unchanged from their currently cleared intended use and functions. The 160MLC™ supports the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation using the conventional linear accelerator. The 160MLC, in conjunction with the Linear Accelerator and control systems, arrough to delivery of X-Ray photon or electron energy for precise treatment of lesions, turnors and onditions anywhere in the body where radiation therapy is indicated.

Refer to Section 11- Description, for the Product Specification regarding these specific modifications.

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 miligations. These potential hazards are controlled by software development, vertification 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 linear accelerator is a high-dose and high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treation ated in the next modulated radiation therapy (IMRT) for lesions, tumors and conditions anywhere in the body when radiation therapy is indicated.

Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multileaf collimator that is marketed as 160MLC™. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485).

510(k) for SIEMENS 160MLC™ Optlon

00032

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Siemens Medical Solutions USA, Inc., Oncology Care Systems

The syngo® Suite for Oncology Workspaces:

Summary:

In summary, it is SIEMENS' belief that the addition of the 160MLC™ option to the ONCOR linear accelerators for high precision radiation therapy does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

510(k) for SIEMENS 160MLC™ Option

CONFIDENTIAL Page Sect. 5/4

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three lines representing the wings and a wavy line representing the body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 1 8 2009

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

Re: K092145

Trade/Device Name: 160MLCTM Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 10, 2009 Received: July 15, 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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

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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Siemens Medical Solutions USA, Inc. Oncology Care Systems

Section 4 Indication For Use Statement

510(k) Number (if known):

Device Name: 160MLC™ Option

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 Device Evaluation (ODE)
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K092145
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use

000029

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.