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 tumors (such as unknown 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 as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney) 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, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

Device Description

The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator. The system consists of two major components: 1) a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault in a healthcare facility and 2) a control console using the device software in an area located outside the treatment room.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and device performance evaluation, formatted to answer your specific questions.

Device: TrueBeam, TrueBeam STx, and Edge Radiotherapy Delivery System
Manufacturer: Varian Medical Systems, Inc.
FDA Submission: K162472
Date: January 19, 2017

It is important to note that the provided document is an FDA 510(k) clearance letter and associated summary, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting raw performance data against specific, quantifiable acceptance criteria in the manner one might find in a clinical trial or a more exhaustive performance study. The "performance testing" section primarily describes the types of testing conducted (e.g., hardware/software V&V, biocompatibility, electrical safety, EMC) and confirms that "passing criteria were met." It does not provide numerical performance metrics or specific acceptance thresholds for output parameters like dose accuracy, beam profile, or treatment delivery precision.

Therefore, the following answers are based on the information available in this specific document. Many of your questions, particularly those related to detailed AI/algorithm study design (like MRMC studies, ground truth establishment methods for large datasets, or specific expert qualifications for image-based diagnostics), are not applicable to this type of device (a radiotherapy delivery system) or the nature of this regulatory submission. This document describes a medical linear accelerator, which is a hardware-based radiation delivery system, not an AI/software diagnostic tool.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a radiotherapy delivery system, the "acceptance criteria" are not reported as specific performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic algorithm. Instead, the acceptance criteria are implicit in the conformance to established standards, successful completion of verification and validation (V&V) testing, and demonstration of substantial equivalence to a predicate device. The document states that "passing criteria were met" for all tests.

Acceptance Criteria Category	Reported Device Performance
Hardware & Software V&V	"Passing criteria were met, device conformance to applicable requirements specifications and assured hazard safeguards functioned properly."
Biocompatibility	"Conducted in accordance with the FDA Blue Book Memorandum #G95-1... and International Standard ISO 10993-1... as recognized by FDA." (Implicitly, the device material biocompatibility met acceptance for patient contact.)
Electrical Safety	"The system complies with the IEC 60601-1 standards for safety." (Implicitly, safety requirements were met.)
Electromagnetic Compatibility (EMC)	"The system complies with the IEC 60601-1-2 standard for EMC." (Implicitly, EMC requirements were met.)
Quality Systems	"Conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards." (Implicitly, the development and manufacturing processes met regulatory standards.)
Software Level of Concern	Designated as "major" level of concern. Software V&V results "showed passing criteria were met 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.'" (Implicitly, software rigor matched risk level.)
Substantial Equivalence	"The results of verification, validation and safety standards bench testing demonstrate that the Varian Medical Systems TrueBeam™, TrueBeam STx™ and Edge™ medical linear accelerators are substantially equivalent to their predicate device." (This is the ultimate regulatory acceptance criterion for a 510(k).)

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

This document does not describe a "test set" in the context of a dataset for an AI algorithm evaluation (e.g., images for classification). The testing described is primarily bench testing and verification and validation (V&V) of system functions. Therefore, there is no information on:

The sample size of a specific test set (e.g., patient data).
Data provenance (country of origin, retrospective/prospective) for a clinical dataset. The V&V testing typically involves engineering tests, phantom measurements, and software functionality checks, not necessarily a large patient cohort study for performance validation.

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

This information is not applicable to this type of device and submission. The ground truth for a radiotherapy delivery system's performance is typically established through:

Physical measurements (e.g., dosimeters, ionization chambers) against known physical principles and standards.
Engineering specifications and design documents.
Mathematical models of radiation physics.
Software testing against expected outputs.
Comparison to existing, validated devices.

Clinical experts (like radiologists) are involved in defining the clinical indications for the device's use, but not in establishing "ground truth" for the device's technical performance in the way they would for an image-based diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of medical images or clinical outcomes, where there can be inter-reader variability. The testing described for this device is physical and software-based V&V, not human-reader performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or reported in this document. MRMC studies are specific to evaluating how AI assistance affects human reader performance with medical images. This device is a radiotherapy delivery system, not an imaging or diagnostic AI tool that assists human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device contains significant software components, the "standalone" performance concept (algorithm-only performance) as typically discussed for AI diagnostics is not applicable in the same way. The software controls the hardware to deliver radiation. The performance is assessed based on the accuracy and precision of the system's (hardware + software) delivered radiation, not an independent diagnostic output. The document states that "Software verification and validation bench testing were conducted. Results showed passing criteria were met..." This confirms the algorithm's functionality within the system.

7. The Type of Ground Truth Used

For a radiotherapy delivery system, the "ground truth" for performance evaluation is typically established through:

Physics principles: Expected dose distribution, beam energy, and geometric accuracy based on fundamental physics.
Reference standards: Calibrated measurement devices (e.g., electrometers, phantom materials).
Predicate device comparison: Performance is compared to an existing, legally marketed device to demonstrate substantial equivalence.

It would not be expert consensus, pathology, or outcomes data in the context of device performance testing, though these are crucial for defining the clinical utility and safety in the broader context of radiation therapy.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the common sense (e.g., labeled images for deep learning). The software within a linear accelerator is typically developed through traditional software engineering paradigms rather than data-driven machine learning models requiring large training datasets for feature extraction and model building.

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

As there is no "training set" in the context of machine learning, this question is not applicable.

Summary

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

January 19, 2017

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K162472

Trade/Device Name: 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: December 22, 2016 Received: December 27, 2016

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) K162472

Device Name

TrueBeam, TrueBeam STx and Edge Radiotherapy Delivery System

Indications for Use (Describe)

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, 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).

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 94304Contact Name: Peter J. CoronadoPhone: 650.424.5731Fax: 650.842.5040Date: December 2016
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: K143224
IV. Device Description:	The TrueBeamTM Radiotherapy Delivery System is a medical linear accelerator.The system consists of two major components: 1) a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault in a healthcare facility and 2) a control console using the device software in an area located outside the treatment room.
V. Intended UseStatement	The TrueBeam TM system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Indications for UseStatement	The TrueBeam, TrueBeam STx 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 tumors (such as unknown 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 as gastric, pancreatic, hepatobiliary, colon, rectal, and anal carcinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney)

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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, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

VI. Technological Characteristics:

Listed below is a comparison of significant changes to the predicate device.

Feature	Cleared device	Device with change
Hyperarc Automated Dynamic Beam	No	Yes
Gated CBCT	No	Yes
Online 4D CBCT	No	Yes
Extended Length CBCT	No	Yes
iCBCT	No	Yes
4D CBCT reconstruction new algorithm	No	Yes
Automatic Exposure Control	No	Yes
Auxiliary Device Interface v3.0	No	Yes
Single Camera for Respiratory Gating	No	Yes

VII. Summary of performance testing:

Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards listed below. Bench testing results showed passing criteria were met, device conformance to applicable requirements specifications and assured hazard safeguards functioned properly.

Software verification and validation bench testing were conducted. Results showed passing criteria were met 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, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

The biocompatibility evaluation for the patient-contact materials in this medical device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

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 Standards accelerator models conform in whole or in part with the following FDA conformance:

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AAMI/ANSI ES60601-1: 2005/(R)2012 & A1:2012; C1:2009/(R)2012 & A2:2010/ (R)2012ANSI/AAMI/ISO 10993-1: 2009	IEC 60601-1-2:2007IEC 60601-1-3: 2013IEC 60601-1-6: 2013IEC 60601-2-1: 2014IEC 60825: 2007	IEC 61217: 2011IEC 62274: 2005IEC 62304: 2006 IEC62366:2015 IEC60976: 2007
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Conclusion: The results of verification, validation and safety standards bench testing demonstrate that the Varian Medical Systems 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.