The intended use of the COHERENCE Workspaces are as optional accessories to the linear accelerator systems to aid and support in the quality assurance, planning and delivery of x-ray radiation for the therapeutic treatment of cancer.

The COHERENCE Workspaces encompasses a number of syngo software applications who's indication for use include the viewing, manipulation, filming, communications, and archiving of medical images and data on exchange media.

The COHERENCE Oncologist Workspace permits localization, contouring, image calibration and 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. The indications for use for the COHERENCE Oncologist 2.0 workspace remain unchanged from the previously cleared COHERENCE Oncologist workspace (K031764).

The COHERENCE Physicist Workspace is a syngo software application package for the use with radiation therapy devices for viewing, manipulation and conditioning, communication and storage of medical images and data on exchange media; and as a quality assurance tool for radiation therapy linear accelerators and their accessories.

Device Description

The COHERENCE Physicist Workspace is an optional accessory to a medical linear accelerator and is based on the previously cleared ONCOR Avant-Garde with COHERENCE Workspaces (K031764) and syngo™ software design architecture previously cleared on the LEONARDO workstation (K040970). The Quality Assurance software applications support the COHERENCE Data Conditioner and customer configurable Quality Assurance applications that Siemens believes are substantially equivalent to those previously cleared on the RIT 113 Film Analysis System (K935928).

The Physicist workspace will support the current manual methodologies for managing quality assurance data using the ONCOR COHERENCE Therapist (or PRIMEVIEW3) workspace) as sources of QA data. The Physicist WS will also offer a suite of customizable QA test protocols (user created and configured macros), test analysis and documentation tools.

The Physicist Workspace will support the COHERENCE Data Conditioner software application which allows the input of DICOM and non-DICOM conforming data objects that have been converted from electronically scanned film (bitmap or TiFF format), EPID data and electronic data from analyzers and The new COHERENCE Data Conditioning application will provide a method of film digitizers. importing non-DICOM data from a variety of electronic media, as mentioned above, and provide the user a method of converting the non-DICOM data into DICOM RT standard images. The DICOM RT standard images can then be processed using a combination of the previously cleared syngo software applications and the new conditioning, calibration and analysis software applications as described in this submission.

The previously cleared COHERENCE Oncologist Workspace provided a syngo based interface for 2D, 3D, and volumetric targeting of the radiation treatment using the Portal Imaging application for the purposes of patient position and setup. This revision to the Oncologist workspace adds.

COHERENCE Data Conditioner: The same syngo based software application module to enable the medical physicist and/or oncologist a method to convert non-DICOM data into DICOM RT conforming data where non image dependent information is missing such as gantry angle, collimator angle, etc.

Adaptive Targeting TM: Improvements to the volume targeting application for advanced Image Guided Radiation Therapy (IGRT) is featured in the new syngo based Adaptive Targeting application module, which supports alignment of 3D planning data for the purposes of patient setup and patient position localization. The Adaptive Targeting application supports the automatic calculation of the table offsets when comparing 3D planning data and current 2D or 3D portal imaging.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the COHERENCE™ Workspaces (Physicist, Oncologist) device:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission typically does not include detailed performance studies with explicit acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies in the way a de novo or PMA submission might. The "study that proves the device meets the acceptance criteria" in a 510(k) context is primarily the demonstration of substantial equivalence by comparing the new device's features and safety/effectiveness to a predicate device.

Given this context, I will extract what information is available and highlight what is not present in the document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments / Source in Text
Functional Equivalence to Predicate Devices: - Processing of QA data. - Support for DICOM and non-DICOM conforming data. - Customizable QA test protocols, analysis, and documentation. - Viewing, manipulation, archiving of medical images and data. - Localization, contouring, image calibration, review of treatment parameters (for Oncologist Workspace). - Enhanced patient positioning accuracy through Adaptive Targeting.	The device, COHERENCE™ Workspaces (Physicist, Oncologist), successfully provides these functionalities. It enables the input, conversion, processing, and display of various QA data types (DICOM and non-DICOM), offers tools for QA practices, and enhances treatment planning and patient setup.	The entire submission implies that the device meets these functional requirements, as it claims substantial equivalence to predicate devices (K031764, K040970, K935928) and describes its new features (Data Conditioner, Adaptive Targeting) as performing these tasks. Page 2-4 describe the new functionalities in detail.
Safety and Effectiveness Equivalence: - The new device should be as safe and effective as the predicate device(s) for its intended use.	The FDA cleared the device, stating it is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."	Page 5, FDA clearance letter.
Compliance with Standards (implicit): - Adherence to medical physics standards (AAPM Task Group 40).	The rationale for development cites AAPM standards as defining current QA practices, implying the device supports these.	Page 1, "The American Association of Physicist in Medicine, (AAPM) currently defines the standard of care for the quality assurance practices..."
Conversion of Non-DICOM to DICOM RT: - Ability to convert electronically scanned film (bitmap/TiFF), EPID data, and electronic data from analyzers/film digitizers into DICOM RT standard images.	The COHERENCE Data Conditioning application is described as providing "a method of importing non-DICOM data from a variety of electronic media... and provide the user a method of converting the non-DICOM data into DICOM RT standard images."	Page 2-3, "COHERENCE Data Conditioner" section.
Automatic Calculation of Table Offsets (Adaptive Targeting): - Ability to automatically calculate table offsets by comparing 3D planning data and current 2D or 3D portal imaging.	The Adaptive Targeting application "supports the automatic calculation of the table offsets when comparing 3D planning data and current 2D or 3D portal imaging."	Page 3, "Adaptive Targeting™" section.

Detailed Study Information from the Provided Text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. A 510(k) submission primarily relies on demonstrating equivalence to predicate devices and describing the new features. It does not typically involve new clinical performance studies with specific test sets and data provenance as would be seen in a PMA or de novo submission. The document describes functionalities and claims equivalence to previously cleared software.
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 explicitly stated. Since there is no mention of a formal "test set" or ground truth establishment process for a new performance study in this 510(k), information regarding experts for ground truth is absent. The document mentions that Medical Physicists, Medical Oncologists, Dosimetrists, and Radiation Therapists define and perform QA practices per AAPM and JCAHO guidelines, implying these professionals use and interpret the data generated by such systems.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated. No adjudication method is mentioned as a formal test set was not described.
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, an MRMC comparative effectiveness study was not done according to the provided document. This document is a 510(k) for an accessory to a linear accelerator, which is software for managing and processing radiation therapy data and QA. It's not an AI diagnostic or assistive device in the sense that would typically warrant an MRMC study comparing human reader performance with and without AI assistance. The "Adaptive Targeting" feature offers automated calculations for position offsets, but this is presented as a functional improvement rather than an AI-driven diagnostic aid requiring MRMC.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not explicitly mentioned as a formal "standalone" study. The device's functionalities, such as calculating table offsets and converting non-DICOM to DICOM, are inherently automated processes. However, these are presented as features of the software accessory rather than a standalone algorithm performance study. The device is an "accessory to a medical linear accelerator" and designed to "aid and support" human users (physicists, oncologists, therapists).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Since a new performance study with a dedicated "test set" and ground truth establishment is not described, the type of ground truth is not detailed. The "ground truth" for radiation therapy QA and planning would generally derive from established clinical protocols, dosimetry measurements, and expert interpretation, which the software aims to facilitate and automate where possible.
The sample size for the training set:
- Not applicable / Not explicitly stated. This device is software for managing and processing radiotherapy data, not a machine learning model that relies on "training sets" in the conventional sense of AI. Its development relies on established physics principles and software engineering practices, ensuring compatibility with existing radiotherapy systems and data standards.
How the ground truth for the training set was established:
- Not applicable / Not explicitly stated. As there's no mention of a "training set" for a machine learning model, the establishment of its ground truth is not discussed.

Summary

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K060633

1 2006 MAY

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)602-8139(925)602-8008christine.dunbar@siemens.com
Proprietary Name:	COHERENCE™ Workspaces (Physicist, Oncologist)
Common Name:	Accelerator, Linear, Medical (Accessories to)
Classification:	892.5050
Product Code:	IYE
Substantial Equivalence Claimed To:

PRODUCT Clearance Claim of Equivalence For: ONCOR Avant-Garde with COHERENCE Workspaces, includes the addition of the K031764 COHERENCE Workspaces COHERENCE Physicist and an upgrade to the Oncologist workspaces. LEONARDO K040970 Syngo based applications on COHERENCE Workspaces RIT 113 K935928 Quality Assurance software applications.

Description Summary:

Within the submission the following internal naming conventions are used:

Market Name	Internal naming convention
ONCOR Avant-Garde	ONCOR linear accelerator and ACCEL release 1
COHERENCE Oncology Workspaces	Suite of oncology focused workspaces
COHERENCE Therapist Workspace	RTT Workspace
COHERENCE Oncologist Workspace	MD Workspace

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Market Name	Internal naming convention
COHERENCE Data Conditioning	Syngo based software application consisting of several micro-applications. Referred to as "CDC" and consists of:o Image Conditionero Image Calibration
LEONARDO	Syngo based workstation
Machine Quality Assurance	MQA - Syngo based software application consisting of severalmicro-applications used for:o Test Preparationo Analysis Toolso Documentation of results.
PRIMEVIEW3i Verify and Recordsystem	PRIMEVIEW3i Verify and Record system has a 510(k) Non-Filing Justification on file because the application differs onlyin name from the COHERENCE Therapist workspace(K031764). The PRIMEVIEW3i V & R is used with the PRIMUSLinear Accelerator.
syngo	Siemens proprietary software architecture and hosting Siemenssoftware applications organized by task cards on a dedicatedworkstation.
TPS	Treatment Planning System

COHERENCE Workspaces (Physicist, Oncologist):

The rationale for the development of this product is as follows:

. The American Association of Physicist in Medicine, (AAPM) currently defines the standard of care for the quality assurance practices', which are defined in a written QA program and performed by a licensed Medical Physicist, a Medical Oncologist, Dosimetrist and/or Radiation Therapist as required by JCAHO2 and other guidelines. The COHERENCE Physicist workspace will provide a dedicated workspace to enable timely quality practices utilizing advanced software packages.
The currently cleared ONCOR Avant-Garde with COHERENCE Workspaces (K031764) . facilitates the quality assurance practices and procedures utilizing manual input of data by the Medical Physicist, Medical Oncologist, Dosimetrist and/or Radiation Therapist. The QA data may be derived from film based dosimetry, electronic portal imaging devices (EPID), ion chambers and other calibration devices, however, the data can only be processed using software based applications if the electronic data conforms to the DICOM RT standard. This

1 Kutcher et al: Report of AAPM Radiation Therapy Committee Task Group 40, Medical Physics, Vol. 21, No. 4. April 1994.

2 Joint Commission on the Accreditation of Healthcare Organizations

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means that the collection of QA data from a variety of sources, specifically electronic image scanners who's output is in a Non-DICOM standard format such as a BITMAP or .TIFF file, cannot be used. The Non-DICOM conforming data requires manual input into electronic spreadsheets or manual data entry into software processing applications (MS Excel™ file). The required output is generally a written report, printed and filed as per the department record retention requirements.

Syngo™:

The original COHERENCE Workspace software (K031764) was based on the software architecture of the previously cleared syngo software (K010938) and allows for a standardized graphical user interface across Siemens medical products. The syngo-based software design consists of task cards allowing for a selection of modules of common software applications for image acquisition, reconstruction, postprocessing, display, and archiving across the Siemens medical product lines. The latest in syngo software applications for the reconstruction, post- processing, manipulation, display and archiving of images are included in the previously cleared workstation under the market name of LEONARDO (K040970).

As part of the Siemens Medical Solutions family of workstations, the syngo based workstations (Oncology Care System calls a "workstation" a "workspace") offers a configurable selection of software applications depending on the type of syngo package that is required for a specific modality. There are multiple applications in common across all Siemens imaging modalities as previously mentioned. In this submission, the COHERENCE Data Conditioner and Adaptive Targeting software modules are shared across several COHERENCE Workspaces.

COHERENCE Oncologist Workspace, Version 2.0.

. COHERENCE Data Conditioner

The same syngo based software application module to enable the medical physicist and/or oncologist a method to convert non-DICOM data into DICOM RT conforming data where non image dependent information is missing such as gantry angle, collimator angle, etc.

. Adaptive Targeting TM

Improvements to the volume targeting application for advanced Image Guided Radiation Therapy (IGRT) is featured in the new syngo based Adaptive Targeting application module, which supports alignment of 3D planning data for the purposes of patient setup and patient position localization. The Adaptive Targeting application supports the automatic calculation of the table offsets when comparing 3D planning data and current 2D or 3D portal imaging.

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Note:

Refer to Section 11 Design Description, for the design description and functional specifications of these new features.

The COHERENCE Physicist and Oncologist Workspaces, will also be available as individual purchased options to existing Siemens PRIMUS and ONCOR medical linear accelerator product lines upon receipt of FDA market clearance notification.

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Intended Use:

The intended use of the COHERENCE Workspaces are as accessories to the linear accelerator systems to aid and support in the quality assurance, planning and delivery of x-ray radiation for the therapeutic treatment of cancer.

The COHERENCE™ Physicist Workspace can be configured with a variety of syngo™ based software options and is intended for use to aid and support quality assurance practices for radiation therapy linear accelerators and their accessories such as Multi-Leaf Collimators, EPIDs, and other electronic devices.

The COHERENCE Physicist workspace has similar technical characteristics as the COHERENCE™ Therapist and Oncologist workspace accessory devices and is to be considered an additional accessory to the previously cleared Primus (K993425) and ONCOR (K031764) radiotherapy linear accelerator product lines.

Also as part of the COHERENCE Oncologist V2.0 revision, the addition of the Adaptive Targeting application enhances the utilization of patient position data derived from 3D imaging applications or imported from another 3D imaging system (i.e. CT or Megavoltage Cone Beam). The Adaptive Targeting application can automatically align the 3D reconstructed image data with the 3D planning data imported from a Treatment Planning System using the calibrated machine isocenter and calculate position offsets. The offset amount can be transferred to the COHERENCE Therapist Workspace then to the treatment table to align the patient's setup position. The image alignment and offset calculation can be performed using both manual and automated tools. Adaptive Targeting is intended to provide a method by which the physician can improve treatment positioning accuracy in conventional fractionated radiation therapy.

The intended use for the COHERENCE Oncologist 2.0 workspace remains unchanged from the previously cleared COHERENCE Oncologist workspace (K031764).

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

1 2006

MAY

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

Re: K060633

Trade/Device Name: Coherence™ Workspaces (Physicist("M and Oncologist™) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 7, 2006 Received: March 9, 2006

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 (Premarket Approval), 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.

Image /page/5/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The seal also includes the years 1906-2006. Below the seal is the text "Protecting and Promoting Public Health" in a decorative font.

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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 (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.

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 this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

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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Section 4 Indication For Use Statement

510(k) Number (if known): __KO60633

Device Name: COHERENCE™ Workspaces (Physicist, Oncologist)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number	K060633
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Prescription Use		OR	Over-the-Counter Use
------------------	---------------------------------------------	----	----------------------

(Per 21 CFR 801.109)

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.