The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: brain and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, ocular tumors, optic nerve tumors, and skull based tumors), head and neck turnors (such as unknown primary of the head and neck, oral cavity, hypopharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as lung cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, cervical, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinomaly tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

Device Description

The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

AI/ML Overview

The provided text describes the regulatory clearance for the Varian TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery Systems but does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document is a 510(k) premarket notification decision letter from the FDA, along with the device's Indications for Use and a 510(k) summary. It primarily addresses the substantial equivalence of the new devices to a previously cleared predicate device (K162472).

Here's what can be extracted and what is missing based on your request:

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

Not provided. The document focuses on regulatory compliance and equivalence to a predicate device, not on specific performance metrics or acceptance criteria for a validation study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not provided. There is no mention of a test set with patient data. The "testing" referred to is primarily hardware and software verification and validation, as well as adherence to safety standards.

3. 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 applicable. This information is for studies involving interpretation or diagnosis, which is not the focus of this clearance document.

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

Not applicable. As above, this is for studies involving interpretation or diagnosis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a radiotherapy delivery system, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant to this submission.

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

Not applicable. This is a hardware and software system for delivering radiation therapy, not a standalone algorithm in the sense of AI for diagnosis or interpretation. The document mentions software verification and validation, but this is for the control of the device, not for an autonomous diagnostic function.

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

Not applicable. Ground truth, in the context of diagnostic or interpretive AI, is not relevant to this device's clearance. The "ground truth" for a radiotherapy delivery system would relate to its physical performance (e.g., dose delivery accuracy, beam shaping accuracy) which is assessed through engineering tests and phantom measurements, not human-read data.

8. The sample size for the training set:

Not provided. This device is not an AI/ML model that would have a "training set" in the typical sense. Its software is developed and validated against requirements and specifications, not trained on data to learn a task.

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

Not applicable. No training set as per the typical understanding of AI/ML.

Summary of available information related to validation/testing from the provided document:

Type of Testing: Hardware and software verification and validation testing, as well as conformance to FDA Quality System Regulation (21 CFR §820), ISO 13485 (Quality Management System), ISO 14971 (Risk Management), and other FDA recognized consensus standards (listed in the table on page 4). This includes electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2).
Software Level of Concern: The software for this device was considered "major" level of concern, meaning "A failure or latent flaw in the software could directly result in serious injury or death to the patient or operator."
Conclusion: The tests demonstrated "conformance to applicable requirements specifications and assured hazard safeguards functioned properly." The conclusion states that the devices are substantially equivalent to their predicate device based on these tests.

In essence, the provided document is a regulatory approval notice based on demonstrating safety, effectiveness, and substantial equivalence to a predicate device through engineering validation and adherence to recognized standards, rather than a clinical performance study with specific acceptance criteria for diagnostic accuracy or similar metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.

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

July 12, 2017

Varian Medical Systems, Inc. % Ms. Sara Muddell Sr. Manager, Americas Submissions 911 Hansen Way PALO ALTO CA 94304

Re: K171733

Trade/Device Name: TrueBeam. TrueBeam STx. and Edge Radiotherapy Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 9, 2017 Received: June 12, 2017

Dear Ms. Muddell:

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. O'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) K171733

Device Name

TrueBeam, TrueBeam STx and Edge Radiotherapy Delivery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System

The following information follows the format of 21 CFR 807.92.

I. Submitter's Name:	Varian Medical Systems, Inc.3120 Hansen Way C-260Palo Alto, CA 94304
	Contact Name: Peter J. CoronadoPhone: 650.424.5731Fax: 650.842.5040Date: June 2017
II. Trade Name:	TrueBeamTM/TrueBeam STXTM/EdgeTM
Common Name:	Linear accelerator radiation therapy system
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: 90 IYE
III. Predicate Device:	TrueBeam Radiotherapy System and Accessories: K162472
IV. Device Description:	The TrueBeamTM Radiotherapy Delivery System is a medical linearaccelerator that integrates the previously cleared Trilogy Radiotherapysystem and associated accessories into a single device.
	The system consists of two major components, a photon, electron,and diagnostic kV X-ray radiation beam-producing component that isinstalled in a radiation-shielded vault and a control console arealocated outside the treatment room.
V. Intended UseStatement	The TrueBeamTM system is intended to provide stereotacticradiosurgery and precision radiotherapy for lesions, tumors, andconditions anywhere in the body where radiation treatment isindicated.
Indications for UseStatement	The TrueBeam, TrueBeam STx and Edge Systems are intended to providestereotactic radiosurgery and precision radiotherapy for lesions, tumors,and conditions anywhere in the body where radiation therapy is indicatedfor adults and pediatric patients.
	The TrueBeam and Edge Systems may be used in the delivery ofradiation for treatment that includes: brain and spine tumors (such asglioma, meningioma, craniopharyngioma, pituitary tumors, spinal cordtumors, hemangioblastoma, orbital tumors, ocular tumors, optic nervetumors, and skull based tumors), head and neck tumors (such asunknown primary of the head and neck, oral cavity, hypopharynx, larynx,oropharynx, nasopharynx, sinonasal, salivary gland, and thyroid cancer),thoracic tumors (such as lung cancer, esophageal cancer, thymic tumors,and mesothelioma), gynecologic tumors (such as ovarian, cervical,endometrial, vulvar, and vaginal), gastrointestinal tumors (such asgastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma),genitourinary tumors (such as prostate, bladder, testicular, and kidney),

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breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's and non-Hodgkin's lymphoma), skin cancers (such as squamous cell, basal cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, ependvmoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

VI. Technological Characteristics:

Significant changes to the predicate device are listed below.

Feature	Cleared device	Device with change
Delta Couch Shift	No	Yes
Enlarged bounding box	No	Yes

VII. Summary of Hardware and software verification and validation testing was conducted performance according to the FDA Quality System Regulation (21 CFR §820). ISO 13485 testing: Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly.

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 as a "major" level of concern A failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

There was no change to the patient-contact materials biocompatibility in this medical device. Therefore no change occurred in conformance to ANSI/AAMI/ ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1"

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

Varian TrueBeam™, TrueBeam STx™ and Edge™ medical linear accelerators Standards conformance: conform in whole or in part with the following FDA recognized consensus standards:

AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012; C1:2009/(R)2012 & A2:2010/ (R)2012	IEC 60601-1-2:2007	IEC 61217: 2011
ANSI/AAMI/ISO 10993-1: 2009	IEC 60601-1-3: 2013	IEC 62274: 2005
	IEC 60601-1-6: 2013	IEC 62304: 2006
	IEC 60601-2-1: 2014	IEC 62366:2015
	IEC 60825: 2007	IEC 60976: 2007

Conclusion: The results of verification, validation and safety standards testing demonstrate that the Varian TrueBeam™, TrueBeam STx™ and Edge™ medical linear accelerators are substantially equivalent to their predicate device.

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.