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 LINAC.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 the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the 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.

Device Description

The PreScision™ Option package is an optional feature to the existing SIEMENS ARTISTE™, ONCOR™ and PRIMUS™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC remain unchanged. The PreScision features upports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy for treatment of lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

The PreScision option supports the delivery of up to 2,000 (± 2%) MU / Minute X-Ray photon beam for either single-session radiosurgery or hypo-fractionated stereotactic treatment using a calibrated 6.67 MV photon energy spectrum consisting of an unflattened beam geometry, a selectable field size of 5cm x 5 cm up to 40cm x 40 cm, collimated by any validated third party stereotactic accessory such as a stereotactic cone or a Multi-leaf collimator, with or without the use of patient motion detection or physiologic gating.

The control console will support the PreScision feature with one unflattened beam energy labeled as "7UF" to differentiate from the previous 6 MV unflattened beam energy used by the predicate Stereo feature. The 7UF option replaces the existing "Stereo" option previously cleared under the PRIMUS™ (K993425) and ONCOR™ (K031764, K060226) and ARTISTE (K072585) devices.

The unflattened X-Ray photon energy spectrum is similar to the 6 MV energy spectrum as used by the PRIMUS™, ONCOR™, ARTISTE Linear Accelerator systems for the predicate Stereo option and is similar to the energy spectrum of the TomoTherapy Hi-Art system as described in Section 11, Design Description.

The SIEMENS linear accelerator product requirements for the PreScision™ option consists of the following:

A SIEMENS ARTISTE™, ONCOR™ or PRIMUS™ Family of Linear Accelerators with the minimum configuration of:

COHERENCE™ Therapist Workspace or the syngo® Radiation Therapist (RTT) with . embedded PRIMEVIEW™ Record and Verify system or the RT Express™ system for the ONCOR™or ARTISTE™ linear accelerator systems.
PRIMEVEIW 3i Record and Verify system used with the PRIMUS™ linear accelerator . system.
58 leaf multi-leaf collimator (MLC) marketed as 3D-MLC, 82 leaf MLC marketed as . OPTIFOCUS™ or the 160 Leaf MLC for:
- Stereotactic Radiotherapy 0
- Stereotactic Radiosurgery o
- Fixed fields, 0
- o Auto-sequenced,
- 0 Arc (Rotation) and
- Intensity Modulated Radiation Therapy (IMRT) treatment delivery methods, 0
. MLC interface to support the SIEMENS ModuLeaf MLC (K030609) for precision Stereotactic or Stereotactic Radiosurgery Radiation TherapyTreatments.
. Gating interface to support Third party, cleared, gating devices for physiologic or patient motion detection.
. Stereotactic mode to support Third party, cleared, stereotactic hardware and patient fixation positioning devices.
An amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) marketed as . OPTIVUE 1000ST
patient treatment couch; 550 TxT™ (K050422), or the ZXT™ (K910971).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Siemens Medical Solutions USA, Inc. Oncology Care Systems PreScision™ Option, based on the provided document:

This document is a 510(k) summary for a medical device (PreScision™ Option). 510(k) summaries, by their nature, do not typically contain detailed clinical study results or performance data in the way a scientific publication would. Instead, they focus on demonstrating substantial equivalence to predicate devices, often through technical characteristics and a summary of verification and validation testing.

Therefore, the information for some of your requested points will be limited or inferred from the types of testing typically performed for such devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or a dedicated performance table in terms of clinical outcomes or diagnostic accuracy for the PreScision™ Option itself.

Instead, it relies on demonstrating that the PreScision™ Option, while adding new capabilities (unflattened beam energy for SRT/SRS), maintains the fundamental design, safety features, and function of the existing linear accelerators and achieves performance similar to its predicate devices. The "performance" described is primarily about the technical capabilities and safety of the system.

Here's an inferred table based on the provided text:

Acceptance Criterion (Inferred from Document)	Reported Device Performance (as described)
New Capabilities
Unflattened Beam Energy Delivery	Supports delivery of up to 2,000 (± 2%) MU / Minute X-Ray photon beam with "7UF" unflattened beam energy.
	Similar to 6 MV energy spectrum of predicate Stereo option and TomoTherapy Hi-Art system.
Safety and Function
Basic Design, Safety Features, Function	Remains unchanged from existing LINACs (ARTISTE™, ONCOR™, PRIMUS™ families).
Supports Stereotactic Radiation Therapy (SRT)	Delivers precision high dose X-Ray photon energy for treatment of lesions, tumors, and conditions.
Supports Stereotactic Radiosurgery (SRS)	Delivers precision high dose X-Ray photon energy for treatment of lesions, tumors, and conditions.
Conformance to Regulations	Device labeling contains instructions for use, cautions, and warnings for safe and effective use.
Risk Management	Ensures via risk analysis (identifies potential hazards, mitigations; controlled by software development, verification, validation).
Electrical and Radiation Hazards Control	Siemens adheres to recognized industry practice and relevant international standards.
Compatibility
Integration with LINAC Ecosystem	Requires ARTISTE™, ONCOR™ or PRIMUS™ LINAC with specific minimum configurations (COHERENCE™ Therapist Workspace, PRIMEVIEW™, various MLCs, gating interface, stereotactic mode, OPTIVUE 1000ST EPID, patient treatment couches).

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

The document does not specify a sample size for a test set in the context of clinical data or patient cases, nor does it indicate data provenance (country of origin, retrospective/prospective).

For a device like this (an option for a linear accelerator), "testing" primarily refers to:

Engineering verification and validation (V&V): This involves extensive technical testing of the hardware and software components, dose measurements, beam characteristics, safety interlocks, and system integration. This kind of testing does not typically involve patient "test sets" in the clinical sense.
Pre-clinical testing: This might involve phantom studies, but the document doesn't detail such studies with specific sample sizes.

The statement "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" refers to this internal engineering V&V process.

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

This question is not applicable in the context of this 510(k) submission. The PreScision™ Option is a treatment delivery system, not a diagnostic device that requires expert-established ground truth for a test set of medical images or patient diagnoses. The "ground truth" for such a device would be its ability to safely and accurately deliver the prescribed radiation dose according, to physical and geometric specifications, as determined by physics and engineering measurements.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. There is no mention of an adjudication method as there is no "test set" of clinical cases requiring expert interpretation and consensus.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is relevant for diagnostic devices that AI would assist human readers with (e.g., radiologists interpreting images). The PreScision™ Option is a radiation therapy delivery system, not an AI-driven diagnostic tool.

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

This question is largely not applicable in its typical sense for this device. The PreScision™ Option is an option for a linear accelerator system, which is inherently a "human-in-the-loop" device (operated by radiation therapists, guided by treatment plans created by dosimetrists/physicians and approved by radiation oncologists). There isn't a standalone algorithm that performs a diagnostic or treatment decision-making task in isolation.

The "standalone" performance would relate to the physical characteristics of the unflattened beam and its delivery, which would be measured in a controlled environment (e.g., using phantoms and dosimeters), rather than an "algorithm only" performance for a clinical task. The document details that the "PreScision features supports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state a "ground truth" in the clinical sense (like pathology for cancer diagnosis). For a radiation delivery device, the "ground truth" for its performance would be established through:

Physics measurements: Verification that the radiation beam (energy, dose rate, field size, uniformity) meets specified physical parameters.
Engineering specifications: Conformance of hardware and software components to design requirements.
Safety standards: Adherence to international safety standards for medical electrical equipment and radiation safety.

The 510(k) process primarily relies on demonstrating that the device meets safety and performance requirements through these types of physical and technical verifications, rather than clinical ground truth from patient data, unless it introduces a new clinical claim requiring such validation.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the PreScision™ Option is not an AI/machine learning-based device in the sense that it requires a "training set" of data for an algorithm. It's an enhancement for an existing radiation therapy delivery system.

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

As there is no mention of a "training set" (see point 8), this question is not applicable.

Summary

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Siemens Medical Solutions USA, Inc. Oncology Care Systems

KOS2225

FEB 1 9 2009

Section 5 510(k) Summary

Submitter: Siemens Medical Solutions USA, Inc. Oncology Care Systems 4040 Nelson Avenue Concord, CA 94520 Contact: Christine Dunbar Senior Regulatory Affairs Specialist Phone: (925)602-8139 Fax: (925)602-8008 Email: christine.dunbar.ext@siemens.com Proprietary Name: PreScision™ 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 Stereo mode with the 160 MLC
SIEMENS ONCOR™Expression	K060226	ONCOR™ and PRIMUS™ linear accelerator familieswith Stereo Mode and COHERENCE Workspaces (or there-branded syngo® Suite for Oncology Workspaces)and the 82 leaf MLC marketed as OPTIFOCUS.
SIEMENS PRIMUSTM	K993425	PRIMUS™ family of linear accelerators with the StereoMode, PRIMEVIEW 3i system, the 58 leaf MLC
Varian Trilogy™	K061140	Stereotactic (SRT) and Stereotactic Radio-Surgery(SRS) Radiation Therapy with high dose beam rate.
TomoTherapy Hi-Art™	K060912	Stereotactic (SRT) and Stereotactic Radio-Surgery(SRS) with unflattened beam delivery and extendedtreatment field for Stereotactic Body Radiation Therapy.
Accuray Cyberknife™	K052325	Stereotactic (SRT) and Stereotactic Radio-Surgery(SRS) robotic delivery system and increased dose ratesfor reduced treatment times.

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

Description Summary:

000026

510(k) for PreScision™ Option

CONFIDENTIAL Page Sect. 5/1

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Siemens Medical Solutions USA, Inc. Oncology Care Systems

Market Name	Internal naming convention
ARTISTE™	ARTISTE™ linear accelerator and ACCEL release 4+
ONCOR™ Expression	ONCOR™ linear accelerator and ACCEL release 2+
ONCOR™ Avant-Garde	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™ 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	Mega-Voltage Cone Beam - a method of obtaining 3 dimensionaldata for portal imaging.
160 MLC™	160-leaf multi-leaf collimator
OPTIFOCUS™	82-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
SRT / SRS	Stereotactic Radiation Therapy/ Stereotactic radiosurgery ~ amethod of using high energy, X-Ray photon radiation for precisiontreatment.
syngo® Therapist Workspace, RTTExpress™	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.

Within the submission the following internal naming conventions are used:

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

Technological Characteristics:

The PreScision™ Option:

The PreScision™ Option package is an optional feature to the existing SIEMENS ARTISTE™,

ONCOR™ and PRIMUS™ family of medical linear accelerator devices [LINAC]. The basic design, safety features and function of the LINAC remain unchanged. The PreScision features upports Stereotation Therapy (SRT) and Stereotactic Radio-surgery (SRT) using the conventional linear accelerator and subsystems for the delivery of precision high dose X-Ray photon energy for treatment of lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

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of 5cm x 5 cm up to 40cm x 40 cm, collimated by any validated third party stereotactic accessory such as a stereotactic cone or a Multi-leaf collimator, with or without the use of patient motion detection or physiologic gating.

The SIEMENS linear accelerator product requirements for the PreScision™ option consists of the following:

A SIEMENS ARTISTE™, ONCOR™ or PRIMUS™ Family of Linear Accelerators with the minimum configuration of:

COHERENCE™ Therapist Workspace or the syngo® Radiation Therapist (RTT) with . embedded PRIMEVIEW™ Record and Verify system or the RT Express™ system for the ONCOR™or ARTISTE™ linear accelerator systems.
PRIMEVEIW 3i Record and Verify system used with the PRIMUS™ linear accelerator . system.
58 leaf multi-leaf collimator (MLC) marketed as 3D-MLC, 82 leaf MLC marketed as . OPTIFOCUS™ or the 160 Leaf MLC for:
- Stereotactic Radiotherapy 0
- Stereotactic Radiosurgery o
- Fixed fields, 0
- o Auto-sequenced,
- 0 Arc (Rotation) and
- Intensity Modulated Radiation Therapy (IMRT) treatment delivery methods, 0
. MLC interface to support the SIEMENS ModuLeaf MLC (K030609) for precision Stereotactic or Stereotactic Radiosurgery Radiation TherapyTreatments.
. Gating interface to support Third party, cleared, gating devices for physiologic or patient motion detection.
. Stereotactic mode to support Third party, cleared, stereotactic hardware and patient fixation positioning devices.
An amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID) marketed as . OPTIVUE 1000ST
patient treatment couch; 550 TxT™ (K050422), or the ZXT™ (K910971). �

Refer to Section 11 Design Description, for the Product Specification regarding these specific product features.

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

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requirements and validation testing. To minimize electrical and radiation hazards. SIEMENS adheres to recognized and established industry practice and relevant international standards.

Intended Use:

The LINAC 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 the PreScision™ option, supports precision stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy, fractionated stereotactic intensity modulated radiation therapy for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

The syngo@ Suite for Oncology Workspaces:

Summary:

In summary, it is SIEMENS' belief that the addition of the PreScision option for enhanced stereotactic radiation therapy and stereotactic radiosurgery (SRT / SRS ) does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2009

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

Re: K082775 .

Trade/Device Name: PreScision™ Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 19, 2008 Received: September 22, 2008

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 such 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.

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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; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 laceling regulation (21) . CFR Part 801) ), please contact the 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.

Sincerely yours,

Lain B. Morris

anine 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): _ K082775

Device Name: PreScision™ 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	K082775
Prescription Use(Per 21 CFR 801.109)	OR Over-the-Counter Use ______

510(k) for PreScision™ Option

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.