The ViewRay System, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Device Description

The ViewRay™ System for Radiation Therapy is a single medical device that combines a magnetic resonance imaging system for image guidance, with a cobalt-60 radiation delivery system. The system is designed so that the imaging and radiotherapy fields of view coincide, permitting imaging of the patient at the radiotherapy isocenter before and during treatment. These imaging and radiation delivery systems are designed to operate together as the ViewRay System, for accurate, targeted administration of radiation therapy. The ViewRay System is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915, FDA clearance 1/12/11).

The magnetic resonance imaging system (MRIS) of the ViewRay System can be used by the clinician to perform three (3) different functions before and during the treatment of a patient. A trained clinician may choose to perform all, some, or none of the functions. These 3 functions are:

Treatment planning the images from the ViewRay MRIS can be used to perform pre-treatment and on-table planning.
Patient positioning Fast pilot or planning volumetric images can be used to position the patient.
Treatment gating (soft tissue tracking)- If the prescribing clinician employs this feature during therapy, planar MR images (in a single plane or in 3 planes) are taken continuously during therapy delivery, to control the beam based on anatomy motion.

The ViewRay radiation delivery system (RDS) consists of:

Radioactive cobalt-60 sources
Source shielding heads and movement mechanism
Gantry and base
Multi-leaf collimators
Radiation therapy control system
User console

The sealed cobalt-60 sources are housed in source-shielding heads made of tungsten alloy and depleted uranium encased with stainless steel. The heads are mounted on a ring gantry located between the gap in the MRIS magnets. The sources can be positioned for therapy (BEAM ON), standby (BEAM HOLD) and shielding (BEAM OFF) by the source movement mechanism. The beams from the sources are shaped to conform to the target using double focused multi-leaf collimators. The radiation therapy interfaces with the radiation treatment planning, imaging, gating, and dose calculation functions by means of the radiation therapy control system (RTCS). This system is the central point of control and is designed to provide fail-safe operation of the ViewRay System. The RTCS includes the Radiation Therapy Controller (RTC) and the Auxiliary Controller (AUXC). The AUXC provides secondary monitoring of the ViewRay System safety functions in the event of an RTC failure. The ViewRay System records patient information, treatment plans, dose administered during each fraction, the accumulated dose, imaging data, and system performance during treatment.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the ViewRay™ System for Radiation Therapy. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics against acceptance criteria in the way a PMA or de novo submission might.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance to design requirements	Passed all verification testing
Ensure all identified risks and hazards were mitigated	Passed all verification testing
Demonstrate conformance to relevant standards: - IEC 60601-1 (2.0 Edition) - IEC 60601-2-33 (3.0 Edition) - IEC 60601-2-11 (2.0 Edition)	Conformed with all applicable sections of IEC 60601-1 (2.0 Edition), IEC 60601-2-33 (3.0 Edition) and IEC 60601-2-11 (2.0 Edition)
Substantial equivalence to predicate device (Trilogy Mx™ Radiotherapy Delivery System K092871)	System performance was found to be equivalent in function to the predicate device.

Note: The document describes "Design Verification testing" as the study proving the device meets these criteria.

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

Sample size: Not specified. The document states "Design Verification testing was performed," but does not detail the number of patients, phantoms, or test cases used.
Data provenance: Not specified. As a 510(k) submission primarily focused on engineering and functional testing, clinical data provenance is not typically detailed in this section unless a specific clinical study for performance was required beyond substantial equivalence.

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

Number of experts: Not specified.
Qualifications of experts: Not specified.
- Rationale: This document describes verification testing against design requirements and standards, not a clinical study requiring expert-established ground truth for performance evaluation in the typical sense of diagnostic or prescriptive AI algorithms. The "ground truth" here would be the established engineering specifications and standard requirements.

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

Adjudication method: Not specified.
- Rationale: As above, this type of adjudication is typically for clinical performance evaluation (e.g., grading images) and not for engineering verification testing described here.

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

MRMC study: No, a multi-reader, multi-case comparative effectiveness study was not explicitly mentioned or indicated in the provided text.
Effect size: Not applicable, as no MRMC study was reported.
- Rationale: The ViewRay system is a medical device combining imaging and radiation delivery for treatment, not an AI-assisted diagnostic tool for human readers in the way an MRMC study would typically evaluate. The text describes the system's capabilities (e.g., continuous imaging for soft tissue tracking) but not as an "AI assistance" to human readers.

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

Standalone performance: Yes, the device itself underwent "Design Verification testing" to show conformance to design requirements and standards. This testing evaluates the device's inherent functionality (imaging quality, radiation delivery accuracy, safety features, etc.) as a standalone system. However, it's not an "algorithm-only" standalone performance in the context of an AI device but rather the integrated system's performance. The document focuses on the system's performance against engineering metrics.

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

Type of ground truth: The "ground truth" for the verification testing described would primarily be:
- Engineering specifications and design requirements: The device was tested to ensure it met its pre-defined design parameters.
- Applicable international standards (IEC 60601 series): The device's performance was compared against the requirements set by these medical device standards.
- Predicate device's established performance: The ViewRay system's function was compared to the Trilogy Mx™ System to demonstrate substantial equivalence, meaning the predicate's performance served as a benchmark for equivalence.

8. The sample size for the training set

Sample size: Not applicable.
- Rationale: This document does not describe the development of an "AI algorithm" in the sense that would require a distinct training set for machine learning. The ViewRay system is a complex integrated medical device, and its functional verification does not typically involve training a machine learning model.

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

Ground truth establishment: Not applicable.
- Rationale: As there is no mention of a training set for an AI algorithm, the concept of establishing ground truth for such a set is not relevant to this document's content.

Summary

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AY 2 2 2012

111862
p'1/3

The future of radiotherapy.

2 Thermo Fisher Way, Oakwood Village Ohio 44146

Premarket Notification [510(k)] Summary The ViewRay™ System for Radiation Therapy

The following information is provided following the format of 21 CFR §807.92.

Submitter's Name:

ViewRay Incorporated 2 Thermo Fisher Way Oakwood Village, OH 44146

Contact Name: Janice Brownlee Phone: 440-703-3210 Fax: 440-703-3229 Date: 17th May 2012

Radionuclide Radiation Therapy System

Product Code (classification): IWB

ViewRay™ System

21 CFR §892.5750, Class II

Proprietary Name:

Classification_Name:

Common/Usual Name:

The ViewRay™ System for Radiation Therapy

Trilogy Mx™ Radiotherapy Delivery System K092871, 11/30/2009

Device Description:

Predicate Device:

Treatment planning the images from the ViewRay MRIS can be used to perform pre-treatment and on-table planning.
Patient positioning Fast pilot or planning volumetric images can be used to position the � patient.

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Treatment gating (soft tissue tracking)- If the prescribing clinician employs this feature during therapy, planar MR images (in a single plane or in 3 planes) are taken continuously during therapy delivery, to control the beam based on anatomy motion.
The ViewRay radiation delivery system (RDS) consists of:
Radioactive cobalt-60 sources
Source shielding heads and movement mechanism
. Gantry and base
Multi-leaf collimators .
Radiation therapy control system
User console .

Statement of Intended Use:

Statement of Indications for Use:

Technological Characteristics:

The ViewRay System functions in a manner directly analogous to the functions provided by the Varian Medical Systems' Trilogy Mx™ Radiotherapy Delivery System. Both the ViewRay and Varian Systems can use images obtained from CT, PET or MRI for planning. Although the Varian System uses a different technology for obtaining images during delivery of treatment (CT vs. MRI) and a source of radiation (linac vs. cobalt-60), both systems are intended for use for radiation therapy, and are used by the same user population. By eliminating the radiation exposure of a CT scan and using MRI instead, the ViewRay System can allow continuous imaging to take place during administration of the radiation therapy,

K111862 Premarket Notification [510(k)] Summary The ViewRay™ System for Radiation Therapy

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thereby keeping the target area in view and minimizing unintended radiation of healthy surrounding tissue.

The ViewRay System employs two well-established technologies, MRI and radiotherapy delivery using cobalt-60 with treatment planning functions to provide a comprehensive IGRT solution. The ViewRay System is substantially equivalent to the imaging and therapy technologies used in the Varian System, CT and linear accelerator. All of these technologies were well established in the marketplace prior to being used together in IGRT systems. Both the ViewRay and Varian systems are used by trained clinicians to provide stereotactic radiosurgery and precision radiotherapy to patients.

Summary of Performance Testing:

Design Verification testing was performed on the imaging and radiation therapy capabilities of the ViewRay System to show substantial equivalence to the predicate device. Additionally, testing was executed on the System to verify conformance to design requirements, to ensure all identified risks and hazards were mitigated, and to demonstrate conformance to relevant standards. The ViewRay System described in this premarket notification passed all verification testing, and the System conformed with all applicable sections of IEC 60601-1 (2.0 Edition), IEC 60601-2-33 (3.0 Edition) and IEC 60601-2-11 (2.0 Edition)

Conclusion:

The ViewRay System for radiation therapy shares many of the technological features and characteristics with its predicate, the Trilogy Mx™ System. Verification testing of the ViewRay System demonstrated that the device met established standards and design requirements for image guided radiation therapy equipment. System performance was found to be equivalent in function to the predicate device. Therefore, the ViewRay System is substantially equivalent to the indicated predicate device.

K111862 Premarket Notification [510(k)] Summary The ViewRay™ System for Radiation Therapy

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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or lines, possibly representing people or services provided by the department.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Janice Brownlee VP Regulatory Affairs and Quality Assurance ViewRay, MRI-Guided RT 2 Thermo Fisher Way OAKWOOD VILLAGE OH 44146

MAY 2 2 2012

Re: Ki11862

Trade/Device Name: The ViewRayTM System for Radiation Therapy Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 21, 2012 Received: March 23, 2012

Dear Ms. Brownlee:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111862

Device Name: The ViewRay™ System for Radiation Therapy

Indications for Use: The ViewRay System, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K111862

Page 1 of

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.