ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES by SIEMENS MEDICAL SOLUTIONS USA, INC.

The intended use of the ONCOR Avant-Garde linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. The ONCOR Avant-Garde includes an Electronic Portal Imaging Device (EPID) that will be marketed as OPTIVUE and is used for the verification of the treatment field and shielding blocks in relation to patient positioning markers and/or anatomical landmarks in radiotherapy treatment. OPTIVUE will also allow for verification of the exit dose in radiotherapy treatment. Additionally, the ONCOR Avant-Garde includes an 82 leaf multi-leaf collimator that will be marketed as OPTIFOCUS. The OPTIFOCUS MLC 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. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

The COHERENCE Workspaces (Therapist and Oncologist) encompasses a number of syngo software applications for viewing, processing, filming, and archiving of medical images. The COHERENCE Therapist and Oncologist Workspaces are two of the software applications that are offered on the syngo workstation (K010938). COHERENCE Therapist Workspace is included in the ONCOR Avant-Garde product. The Therapist Workspace permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording.

The COHERENCE Oncologist Workspace permits localization, contouring, image conditioning, and review of treatment parameters. In addition, it includes tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

Device Description

The ONCOR Avant-Garde is a medical linear accelerator based on the previously cleared PRIMUS design architecture (K993425) and includes an amorphous Silicon (aSi) flat panel electronic portal imaging device (EPID), an 82 leaf multi-leaf collimator (MLC), and COHERENCE Therapist Workspace software.

The aSi flat panel (marketed as OPTIVUE) is integrated into the ONCOR Avant-Garde system and aids in positioning verification by visualizing patient positioning markers and/or anatomical references. The flat panel detects radiation from the linear accelerator, this information is then interpreted via software to obtain visualization of patient positioning markers and/or anatomical structures. The OPTIVUE flat panel detector is a digital x-ray camera comprised of sensors. These sensors are amorphous Silicon (aSi) photo diodes that are placed on a glass substrate with scintillator coating. The incident x-rays are converted by the scintillator screen. The converted x-ray signals are then amplified and converted to a digital format. This digital formatted data is then transmitted to the data acquisition unit or frame grabber and interpreted into positioning images. The OPTIVUE includes automated deployment of the flat panel that eliminates the need to enter the treatment room to acquire portal images, thus improving the efficiency of patient treatments.

The 82 leaf multi-leaf collimator (marketed as OPTIFOCUS) is integrated into the ONCOR Avant-Garde system and allows for user definable optimization of resolution for target conformation. The OPTIFOCUS is based on the same architectural design as the previously cleared 58 leaf MLC (K953894). The increase in the number of leaves in the collimator allows for increased conformal shape resolution.

The COHERENCE Workspace software is based on the architecture of the previously cleared syngo software (K010938) and allows for a standard graphical user interface across Siemens medical products.

The COHERENCE Therapist Workspace software integrates the linear accelerator processes of setup. setup verification, patient positioning verification, treatment delivery, and recording. The COHERENCE Therapist Workspace provides a simple interface for 2D. 3D. and volumetric targeting of the radiation treatment. Patient management is facilitated by easy access to all pertinent patient data with the integration of previously cleared functionality. The Therapist Workspace integrates various functions from previously cleared products (ie. VSIM marketed as COHERENCE Dosimetrist (K022036), syngo Workstation (K010938), and LANTIS Treatstation marketed as PRIMEVIEW (K972275).

The COHERENCE Oncologist Workspace software is an option for the ONCOR Avant-Garde linear accelerator and provides access to patient data, images, and tools needed to help facilitate the Oncologist in performing accurate and timely clinical decisions. Multi-modality images can be loaded and manipulated with the advanced tools allowing for efficient localization and contouring of tumors and critical anatomical structures. The COHERENCE Oncologist Workspace provides access to all radiation therapy plans, visualization of suggested alternate plans, and comparisons with prior treatment plan data. In addition, it provides for treatment verification of patients with access to pertinent treatment data allowing for full treatment review. The COHERENCE Oncologist Workspace is based on the previously cleared syngo architecture (K010938). The COHERENCE Oncologist Workspace is also based on functionality cleared under VSIM via K022036 and permits localization, contouring, image conditioning, and review of treatment parameters. In addition, there are tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

The OPTIVUE, OPTIFOCUS, and COHERENCE Therapist Workspace, may also be available as individual purchased options to existing Siemens medical linear accelerators.

AI/ML Overview

This document, K031764, is a 510(k) summary for the ONCOR Avant-Garde with COHERENCE Workspaces. It is primarily a filing for substantial equivalence to predicate devices, meaning it aims to show it's as safe and effective as existing, legally marketed devices. As such, it does not contain the detailed acceptance criteria and study data typical for a device proving novel performance or efficacy.

The document focuses on describing the device, its intended use, and identifying predicate devices it is substantially equivalent to. It explicitly states the intended uses remain unchanged from the predicate devices. This type of submission relies on the prior approval of the predicate devices rather than new, extensive performance studies for novel claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and comparative effectiveness studies are not present in this 510(k) summary because they are not required for a substantial equivalence determination to this extent.

However, I can extract the information that is present and explain why other information is absent.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, explicit quantitative acceptance criteria for new performance claims are not provided. Instead, the "acceptance criteria" can be inferred as demonstration that the device's components perform similarly or identically to their predicate devices. The "reported device performance" is essentially the device functioning as intended, mirroring the predicate's performance.

The submission emphasizes that the intended uses for all components (ONCOR Avant-Garde, OPTIVUE, OPTIFOCUS, COHERENCE Workspaces) remain unchanged from their respective predicate devices. This forms the basis of the substantial equivalence claim.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as implied by the 510(k))
ONCOR Avant-Garde Linear Accelerator: Deliver x-ray radiation for therapeutic treatment of cancer, performing similarly to PRIMUS (K993425) and Mevatron KD2 (K862339).	The ONCOR Avant-Garde is a medical linear accelerator based on the previously cleared PRIMUS (K993425) design architecture and is intended to deliver x-ray radiation for therapeutic treatment of cancer. Its performance is considered substantially equivalent to the predicates.
OPTIVUE EPID: Verification of treatment field and shielding blocks in relation to patient positioning markers/anatomical landmarks; verification of exit dose; provides patient positioning reference data, similar to BeamView (K903139).	The OPTIVUE is an aSi flat panel EPID integrated into the system, aiding in positioning verification by visualizing patient positioning markers and/or anatomical references, detecting radiation to obtain images. Its intended use is the same as the BeamView EPID (K903139), providing patient positioning reference data and allowing verification of exit dose. The flat panel is amorphous Silicon photo diodes on a glass substrate with scintillator coating.
OPTIFOCUS MLC: Assist radiation oncologist in delivery of radiation to defined target volumes while sparing normal tissue; static mode functions like customized shadow blocks; dynamic mode creates changing beam shape for 3D dose distribution, similar to 58 leaf MLC (K953894).	The OPTIFOCUS is an 82-leaf multi-leaf collimator, based on the same architectural design as the previously cleared 58 leaf MLC (K953894). It allows for user-definable optimization of resolution for target conformation, delivering radiation to target volumes while sparing normal tissue in static and dynamic modes. The increase in leaves provides increased conformal shape resolution.
COHERENCE Therapist Workspace: Patient data management, selection/setup, positioning verification, treatment delivery/verification, and recording; based on syngo (K010938), VSIM (K022036), and LANTIS Treatstation (K972275).	The COHERENCE Therapist Workspace integrates linear accelerator processes, providing a simple interface for 2D, 3D, and volumetric targeting. It facilitates patient management and integrates functionality from previously cleared products (VSIM/COHERENCE Dosimetrist (K022036), syngo Workstation (K010938), LANTIS Treatstation/PRIMEVIEW (K972275)).
COHERENCE Oncologist Workspace: Localization, contouring, image conditioning, review of treatment parameters, diagnosis, staging, and prescription of radiation therapy; based on syngo (K010938) and VSIM (K022036).	The COHERENCE Oncologist Workspace provides access to patient data, images, and tools for oncologists, based on the previously cleared syngo architecture (K010938) and functionality from VSIM (K022036). It allows for multi-modality image manipulation, localization, contouring, and review of treatment parameters, including administrative functions for diagnosis, staging, and prescription of radiation therapy.

Specific Study Information (Not Present in this 510(k) Summary)

The following information is not provided in the given 510(k) summary, as it describes a substantial equivalence claim based on predicate devices, rather than a de novo submission or a claim of new performance.

Sample size used for the test set and the data provenance: Not provided. Performance testing would have been done to ensure safety and functionality, but details about specific image or patient datasets for a "test set" demonstrating performance metrics are not included. Data provenance (country, retrospective/prospective) is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This type of information is relevant for studies validating diagnostic or interpretive AI, which is not the primary focus of this submission, though the software aids these processes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 provided. This type of study would be highly relevant for AI-assisted diagnostic devices, but this submission focuses on the safety and foundational functionality of radiation therapy equipment and software tools, not a primary diagnostic AI. The software "aids in the diagnosis, staging, and prescription" but is not explicitly making diagnostic claims that would require an MRMC study here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. Given the nature of the device (radiation therapy system and associated software), human clinicians are always in the loop.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly provided for new studies. For devices claiming substantial equivalence, the "ground truth" for ensuring safety and effectiveness relies on the established performance and safety of the predicate devices.
The sample size for the training set: Not applicable and not provided. This device is not presenting a novel AI model that requires a specific training set in the context of this 510(k). The software (COHERENCE Workspaces) is based on existing, cleared software architectures (syngo, VSIM, LANTIS).
How the ground truth for the training set was established: Not applicable and not provided.

Summary

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KA031764

Tab A 510(k) Summary

Submitter:	Siemens Medical Solutions USA, Inc.Oncology Care Systems Group4040 Nelson AvenueConcord, CA 94520
Contact:	Ken NehmerManager of Regulatory Affairs
Phone:Fax:Email:	(925)602-8011(925)602-8008ken.nehmer@siemens.com
Proprietary Name:	ONCOR Avant-Garde with COHERENCE Workspaces
Common Name:	Accelerator, Linear, Medical
Classification:	892.5050
Product Code:	IYE
Substantial Equivalence Claimed To:
PRIMUSMevatron KD2	K993425 K862339	(equivalence for ONCOR Avant-Garde linear accelerator)(equivalence for ONCOR Avant-Garde linear accelerator)
BeamViewPortalVision	K903139 K003636	(equivalence for OPTIVUE Electronic Portal Imaging Device)(equivalence for OPTIVUE Electronic Portal Imaging Device)
58 leaf MLC	K953894	(equivalence for OPTIFOCUS 82 leaf multi-leaf collimator)
(VSIM) Dosimetrist	K022036	(equivalence for COHERENCE Workspaces)
syngo Workstation	K010938	(equivalence for COHERENCE Workspaces)
LANTIS Treatstation	K972275	(equivalence for COHERENCE Workspaces)

Description:

Within the submission the following internal naming conventions are used:

Market Name	Internal naming convention
ONCOR Avant-Garde	ACCEL linear accelerator
ONCOR Avant-Garde	ACCEL release 1
COHERENCE Therapist Workspace	RTT Workspace
COHERENCE Oncologist Workspace	MD Workspace
OPTIFOCUS	82-leaf multi-leaf collimator
OPTIVUE	aSi flat panel electronic portal imaging device (EPID)

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Tab H through Tab J for detailed information regarding the ONCOR Avant-Garde linear accelerator requirements and specifications.

The COHERENCE Workspace software is based on the architecture of the previously cleared syngo software (K010938) and allows for a standard graphical user interface across Siemens medical products. Efficiency can be improved by this standard graphical interface in that common tasks are presented similarly across the Siemens medical product line.

The OPTIVUE, OPTIFOCUS, and COHERENCE Therapist Workspace, may also be available as individual purchased options to existing Siemens medical linear accelerators.

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Intended Use:

Additionally, the ONCOR Avant-Garde includes an 82 leaf multi-leaf collimator that will be marketed as OPTIFOCUS. The OPTIFOCUS MLC 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. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution. The intended use of the OPTIFOCUS is unchanged from the previously cleared 58 leaf MLC (K953894).

The COHERENCE Therapist Workspace is included with the ONCOR Avant-Garde system and is based on the previously cleared syngo architecture (K010938). The COHERENCE Therapist Workspace is a software application that permits patient data management, patient selection/setup, patient positioning verification, treatment delivery/verification, and treatment recording. The Therapist Workspace integrates various from previously cleared products (ie. VSIM marketed as COHERENCE Dosimetrist (K022036), syngo Workstation (K010938), and LANTIS Treatstation marketed as PRIMEVIEW (K972275).

The COHERENCE Oncologist Workspace is an option to the ONCOR Avant-Garde system and is also based on the previously cleared syngo architecture (K010938). The COHERENCE Oncologist Workspace is based on functionality cleared under VSIM via K022036 and permits localization, contouring, image conditioning, and review of treatment parameters. In addition, there are tools and administrative functions to aid in the diagnosis, staging, and prescription of radiation therapy.

The intended uses of the ONCOR Avant-Garde including the OPTIVUE flat panel EPID and OPTIFOCUS multi-leaf collimator remain unchanged from the predicate devices.

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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three parallel lines forming the body and wings. The bird is enclosed within a partial circle, with text following the curve of the circle. The text is small and difficult to read, but it appears to be a company or organization name.

SEP 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ken Nehmer Manager of Regulatory Affairs Siemens Medical Solutions Oncology Care Systems Group 4040 Nelson Avenue CONCORD CA 94520

Re: K031764 Trade/Device Name: ONCOR Avant-Garde with COHERENCE Workspaces Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: June 5, 2003

Received: June 9, 2003

Dear Mr. Nehmer:

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); 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

<031764

Device Name: ONCOR Avant-Garde with COHERENCE Workspaces

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) /

Over-the-Counter Use

David A. Liggons

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.