Varian Treatment is designed to assist the operator of a radiation therapy device by retrieving treatment plans from the Varian System Database for ARIA® Radiation Therapy Management, by providing accurate treatment setups, by monitoring setup parameters, by preventing treatment when machine parameters are out of conformance to treatment plan parameters, and by sending the treatment history for recording to the Varian System Database.

Device Description

Varian Treatment (VTx) is a treatment delivery management application that performs an interface role between the ARIA® Oncology Information System for Radiation Oncology (ARIA OIS RO); ARIA® Radiation Therapy Management System (ARIA RTM), and an external radiation therapy delivery system (e.g., medical linear accelerator). The contents of this submission are applicable to version 13.0 of Varian Treatment.

The device does not contain any biologics or drug components. The device is not intended for single use. No parts of the system are provided sterile or are intended for sterilization. There are no patient-contacting materials. Varian Treatment is operated by radiation therapy therapists in accordance with the prescription of a radiation oncologist and under the general supervision of a chief therapist and medical physicist. Healthcare/treatment facilities are the intended environment of use.

The associated hardware for Varian Treatment consists of:

Single workstation
Two 27-inch monitors
Mouse
Keyboard
In-Room Keypad
MICAP
KVM Switch
Display Port Switcher
Connecting Cables (Network, Serial, and Fiber)
Barcode Reader (Optional Accessory)

The VTx workstation is the computer that hosts the system software described in this section. This workstation uses a mouse and keyboard for the operator's control in the treatment control room. Varian Treatment is connected over the institution's corporate network to the Varian system database via MICAP (firewall). Varian Treatment uses an inroom monitor and kevpad to allow the operator certain functions from the treatment room. Barcode readers are connected to the VTx workstation for use with either PAVS or VVS when licensed (optional); these barcode readers are used for patient and accessory verification. The Display Port Switcher allows for switching between the In-Room monitor application and the Varian Treatment main application from the treatment room when PAVS or VVS is licensed. The KVM Switch and other Connecting Cables are used in connecting the in-room monitor to the VTx workstation.

The main software application for Varian Treatment provides functionality to load a patient session from the Varian System database, validates patient data, sends data to the treatment control system for the linear accelerator, verifies actual parameters versus planned parameters, receives treatment history and saves it to the Varian System database. VTx Administration is the administrative application for the main application, allowing a user to view, modify, and save configuration settings, user and group management, and group rights management for the VTx application. The Multivendor DICOM Service (MVDS) application acts between the main application and the external vendor's imaging system in supported, compatible devices. The VTx system software operates on a Microsofte Windows® operating system on the workstation.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called Varian Treatment (VTx), which is software designed to manage radiation therapy treatment delivery. The document outlines the device's indications for use, comparison to a predicate device, and performance data used to establish substantial equivalence.

However, the document does not contain the specific information requested about acceptance criteria, detailed study results for device performance (especially in a clinical or multi-reader multi-case setting), sample sizes for test/training sets, expert qualifications for ground truth establishment, or adjudication methods. The performance data section primarily discusses non-clinical tests like software verification and validation, with explicit statements that no animal studies or clinical tests were included.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with explicit acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) and corresponding reported device performance in a quantitative sense as might be expected for an AI/ML diagnostic system. Instead, it states that "The result of the software verification and validation testing was that the product conformed to the defined user needs, intended uses, and safety requirements." This is qualitative and refers to general software functionality rather than specific performance metrics against a clinical ground truth.

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

The document states that "Software verification and validation testing were conducted and documentation was provided." It does not specify the sample size of data used for this testing, nor does it mention the data provenance (e.g., country of origin, retrospective/prospective). Since no clinical studies were performed, there isn't a "test set" in the sense of patient data.

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

Not applicable. The ground truth for software verification and validation tests would be the expected output or behavior of the software based on its design specifications, not expert consensus on medical images or diagnoses. No clinical test set requiring expert ground truth was mentioned.

4. Adjudication method for the test set

Not applicable. No clinical test set, therefore no adjudication method for establishing 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

The document explicitly states: "No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination." Therefore, no MRMC study was performed.

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

The software (VTx) is described as "designed to assist the operator of a radiation therapy device" and "performs an interface role." It is inherently a human-in-the-loop system (an assistant tool for operators), not a standalone diagnostic algorithm. The performance evaluation focused on its functional correctness and safety as a software component, not its standalone diagnostic or treatment effectiveness.

7. The type of ground truth used

For the software verification and validation, the ground truth was the defined user needs, intended uses, and safety requirements of the software. This is a functional truth, not a clinical truth based on pathology, expert consensus, or outcomes data.

8. The sample size for the training set

Not applicable. This device is described as software that manages treatment delivery, verifies parameters, and sends data. It's not an AI/ML model that would typically have a distinct "training set" in the sense of learning from large datasets of clinical images or patient outcomes. The software development process would involve coding and internal testing, not machine learning training.

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

Not applicable, as there's no mention of a traditional "training set" for an AI/ML model.

Summary Table of Available Information based on the provided document:

Acceptance Criteria Aspect	Information from provided document
1. Acceptance Criteria & Reported Device Performance	Acceptance Criteria: "conformed to the defined user needs, intended uses, and safety requirements."
	Reported Performance: "The result of the software verification and validation testing was that the product conformed to the defined user needs, intended uses, and safety requirements." (Qualitative statement, no quantitative metrics provided like accuracy, sensitivity, specificity, etc.)
2. Test Set Sample Size & Data Provenance	Sample Size: Not specified.
	Data Provenance: Not specified. No clinical test set mentioned. The testing was for software verification and validation.
3. Experts for Ground Truth & Qualifications	Not applicable. No clinical test set requiring expert ground truth.
4. Adjudication Method for Test Set	Not applicable.
5. MRMC Comparative Effectiveness Study Performed? Effect Size?	No. "No animal studies or clinical tests have been included."
6. Standalone Performance Study Performed?	Not applicable. This is a human-in-the-loop assistance device, not a standalone diagnostic algorithm. Performance focused on functional correctness as software.
7. Type of Ground Truth Used	Defined user needs, intended uses, and safety requirements of the software.
8. Training Set Sample Size	Not applicable. No AI/ML training set mentioned.
9. How Training Set Ground Truth Established	Not applicable.

In conclusion, the provided FDA 510(k) document for Varian Treatment (VTx) focuses on demonstrating substantial equivalence primarily through non-clinical software verification and validation. It explicitly states that no animal or clinical studies were performed. Therefore, the detailed performance metrics, test/training set descriptions, and human expert involvement typically associated with AI/ML device evaluations (as implied by the requested questions) are not present in this document. The "proof" relies on the software meeting its specified design requirements and being functionally equivalent to its predicate.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 26, 2015

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K151882 Trade/Device Name: Varian Treatment (VTx) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 22, 2015 Received: September 25, 2015

Dear Mr. Coronado:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151882

Device Name Varian Treatment (VTx)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038

Telephone: 1.650.493.4000 Toll Free: 800.544.4636

www.varian.com

510k Summary

510k Submission for Varian Treatment (VTx)

A partner for life

As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]"(June 2014).

l. SUBMITTER

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E-110Palo Alto CA 94304-1038
Contact Name:	Peter J. Coronado

Contact Name:	Peter J. Coronado
Position:	Director, Regulatory Affairs
Phone:	1.650.424.6230
Fax:	1.650.646.9200
Email:	submissions.support@varian.com
Date Prepared:	Monday July 06, 2015

ll. DEVICE

Name of Device:	Varian Treatment
Version:	Version 13.0
Common/Usual Name:	Accelerator, Linear, Medical
Regulation Name:	Medical charged-particle radiation therapy system
Regulatory Class:	Class II
Product Code:	IYE

PREDICATE DEVICE lll.

Name of Predicate:	Varian Treatment
Version:	Version 6.6
510(k) Number:	K093967

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IV. DEVICE DESCRIPTION

The associated hardware for Varian Treatment consists of:

Single workstation ●
. Two 27-inch monitors
Mouse .
Keyboard ●
In-Room Keypad ●
MICAP ●
KVM Switch .
Display Port Switcher ●
Connecting Cables (Network, Serial, and Fiber)
Barcode Reader (Optional Accessory) .

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Additional details on the device features, design, and use were provided in the Device Description of this submission.

INDICATIONS FOR USE V.

Indications for Use Statement: Varian Treatment is designed to assist the operator of a radiation therapy device by retrieving treatment plans from the Varian System Database for ARIA® Radiation Therapy Manaqement, by providing accurate treatment setups, by monitoring setup parameters, by preventing treatment when machine parameters are out of conformance to treatment plan parameters, and by sending the treatment history for recording to the Varian System Database.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Both the subject and predicate devices are software that acts to interface between the ARIA® Oncology Information System for Radiation Oncology (ARIA OIS RO): ARIA® Radiation Therapy Management System (ARIA RTM), and an external radiation therapy delivery system (e.g., medical linear accelerator).

At a high level, the subject and predicate devices are based on the following same technological elements:

Main software application used to interface between designated systems ●
Verification of accurately transferred parameter fields and information .
Prevention of treatment when machine parameters are out of conformance with . treatment plan parameters
. Use of a barcode system (optional) to verify patient and treatment details
Use with supported third-party medical linear accelerator devices
Use with the Varian oncology information system (ARIA) ●
. Use of in-room components for operator access in treatment room

The following main differences exist between the subject and predicate devices:

Compatibility with Windows® 7 x64, Embedded ●
Support of QA Mode ●
. Support for additional treatment techniques available on certain compatible linacs
. Support of Varian Verification System (VVS)
Added compatibility with Elekta Versa HD linac, Siemens ONCOR linac ●
. Added compatibility with ARIA 13.5 and 13.6
Added Complete Irradiation Aperture Outline (CIAO) display feature ●

Further details about the differences between the predicate and subject device were included in the Substantial Equivalence Discussion of this submission.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Tests:

Biocompatibility Testing:

This item is not applicable to subject device; there are no patient-contacting components. No biocompatibility tests have been included in this submission in support of the substantial equivalence determination.

Electrical Safety and Electromagnetic Compatibility (EMC):

This item is not applicable to subject device: the device is software. No electrical safety and electromagnetic compatibility tests for the subject device. Varian Treatment, have been included in this submission in support of the substantial equivalence determination.

The computer workstation supplied by Varian is manufactured by a third-party representative and was tested against electrical safety and EMC requirements of the following standards: EN 55022 (Class B), EN 61000-3-2, EN 61000-3-3, EN 55024, & IEC 60950-1. The computer workstation that was provided with the predicate device met similar applicable electromagnetic compatibility and electrical safety requirements. As such. Varian believes that the computer workstation accessory hardware demonstrates equivalent performance with respect to EMC compatibility and electrical safety.

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "major" level of concern as the device is an accessory to a device with "major" level of concern.

Verification and Validation testing was performed for all new software features and regression testing was performed against the existing features of Varian Treatment. System requirements created or affected by the device changes can be traced to the corresponding test results. The result of the software verification and validation testing was that the product conformed to the defined user needs, intended uses, and safety requirements.

Varian therefore considers the subject device software to be safe and effective and to perform at least as well as the predicate device software as demonstrated by the results from testing. There are no changes to the principle of operation of the software. The new software features are all considered by Varian to be enhancements of the predicate.

Mechanical and Acoustic Testing:

This item is not applicable to subject device; the device is software. No mechanical or acoustic tests have been included in this submission in support of the substantial equivalence determination.

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Animal Study / Clinical Tests:

No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.

CONCLUSIONS VIII.

The results of the non-clinical tests support the safety of the device and software verification and validation demonstrate that subject device. Varian Treatment Version 13.0, performs as intended in the specified use conditions. The non-clinical data also demonstrates that Varian Treatment version 13.0 is as safe and effective as and performs as well as or better than the predicate device, Varian Treatment version 6.6 (K093967).

Regulation Number and Section

N/A