A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

Device Description

The GammaBeam 500 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system that is designed to be a dedicated, standalone device for performing total body irradiation (TBI). The device consists of a source head, main frame, base, and controls. The design of this device is substantially equivalent to the predicate device Theratron Phoenix.

The GammaBeam 500 is aimed to deliver total body irradiation to patients by generating a large fixed radiation treatment field at an extended Source - to - Skin Distance (SSD). This is a common radiotherapy technique performed by many clinics worldwide. A dedicated device improves the safety, effectiveness and clinical workflow of these treatments.

The unit will be operated in a similar manner as the predicate and has the same redundant mechanisms for safety, auxiliary source drawer lock, secondary and manual source return, emergency stop switches on the unit and control console, source position indicator, and operational and inhibit state interlocks.

AI/ML Overview

The provided document is a 510(k) summary for the GammaBeam 500, a Cobalt Teletherapy unit. It primarily focuses on demonstrating substantial equivalence to a predicate device (Theratron Phoenix) rather than detailing specific clinical study results or acceptance criteria for a novel device's performance metrics.

Based on the information provided, here's an analysis of the acceptance criteria and supporting studies as much as can be discerned:

The document does not present specific acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for a device's diagnostic or predictive capabilities in the typical sense of a medical imaging or AI device. Instead, the acceptance criteria relate to regulatory compliance, safety, and functional equivalence to a predicate device.

The "study that proves the device meets the acceptance criteria" is a collection of non-clinical tests and verification/validation activities.

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

The document doesn't provide a table of acceptance criteria for diagnostic/predictive performance. Instead, it lists standards for safety and EMC, and functional specifications. The "reported device performance" is the conclusion that the device complies with these standards and performs as intended.

Acceptance Criteria (Category)	Specific Standard/Requirement	Reported Device Performance
Safety & EMC	IEC 60601-1:2013 Edition 3.1 (Medical electrical equipment - General requirements for basic safety and essential performance)	System complies with the standard for safety.
	IEC 60601-1-2:2007 Edition 3.0 (Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)	System complies with the standard for EMC.
	EN 60601-2-11:2011 Edition 3.0 (Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment)	System complies with the standard for safety of gamma beam therapy equipment.
	EN 61217 (2014) (Radiotherapy equipment Coordinates, movements and scales)	System complies with the standard.
Software	Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Software level of concern: "major" - failure could result in serious injury or death).	Software verification and validation testing were conducted and documentation was provided, demonstrating that the software performs as intended.
Mechanical Performance	Functional specifications (simulated actual operating environment)	Mechanical validation of the main unit and patient couch, physics validation, and simulated use testing were performed. The device performs as intended in the specified use conditions.
Substantial Equivalence	The device is "as safe and effective as the predicate device that is currently marketed for the same intended use." This is the overarching "acceptance criterion" for a 510(k).	The non-clinical data support the safety of the device and the hardware and software verification and validation support that the GammaBeam 500 performs as intended in the specified use conditions, demonstrating substantial equivalence.

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

This document refers to "non-clinical data" and "testing" rather than a clinical trial with a "test set" of patient data. The tests performed are:

Electrical safety and electromagnetic compatibility (EMC) testing.
Software Verification and Validation Testing.
Mechanical Testing (mechanical validation, physics validation, simulated use testing).

These are engineering and software validation activities, not clinical studies on patient samples. Therefore, the concepts of "sample size for a test set" and "data provenance" in the context of patient data do not apply here. The testing was conducted on the GammaBeam 500 unit itself, and its components (main unit and patient couch).

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)

This information is not applicable as the document does not describe a clinical study with a "test set" relying on expert interpretation for ground truth. The "ground truth" for these engineering tests would be derived from the specifications and expected physical/electrical performance defined by engineers and physicists.

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

Not applicable, as there is no clinical test set requiring adjudication.

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 is a medical device for radiation therapy delivery, not an AI diagnostic or assistance tool. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant 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 device for radiation therapy. While it has a control system (software), its performance validation focuses on its safety and functional equivalence in delivering radiation, not on standalone interpretive algorithmic performance.

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

The "ground truth" for the non-clinical tests would have been established by:

Standards for Safety and EMC: The defined requirements and limits specified in the referenced IEC and EN standards.
Software Verification and Validation: Software requirements specifications, design documents, and expected outputs/behaviors.
Mechanical and Physics Validation: Engineering specifications, design documents, and expected physical behavior/radiation output measurements based on established physics principles and industry best practices for teletherapy units.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set" of data in the typical sense.

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

Not applicable. No training set was used.

Summary

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

April 17, 2015

Best Theratronics Limited % Mr. Mike de van der Schueren Quality & Regulatory Manager 413 March Road Ottawa, Ontario K2K 0E4 CANADA

Re: K150191

Trade/Device Name: GammaBeam 500 Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 18, 2015 Received: February 19, 2015

Dear Mr. de van der Schueren:

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. Acting 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) K150191

Device Name GammaBeam 500

Indications for Use (Describe)

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

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)

| X Prescription Use (Part 21 CFR 801 Subpart D)

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Date Summary Prepared	January 23, 2015
Submitted by	Best Theratronics413 March RoadOttawa, Ontario K2K 0E4CanadaTel. (613) 591-2100Fax. (613) 592-5680
Contact Person	Mr. Mike de van der SchuerenQuality & Regulatory Manager
Trade Name	GammaBeam 500
Common Name	Cobalt Teletherapy Device
Classification Name	Radionuclide Radiation Therapy System
Legally Marketed Predicate Device	Theratron Phoenix (K863180)
Device Classification	Class II, 21 CFR 892.5750
Product Code	IWB

DESCRIPTION OF DEVICE

INTENDED USE OF DEVICE

A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the treatment of cancer under the direction of health care professionals in a radiation therapy clinic.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The GammaBeam 500 is substantially equivalent to the predicate device (K863180).

This GammaBeam 500 includes several changes to the design of Phoenix teletherapy unit.

Device Characteristic	Predicate Device	Proposed Device
Control System	Single computer in control room	Separate main controller and graphic userinterface that performs same functionalitywith added safety features, improveduseability and battery backup
Treatment Mode	Rotational and/or fixed treatments witha variable field size	Fixed treatments only and fixed field sizereduces complexity and eliminates collisionhazards and hazards related to treatmentsetup
Patient Table	Vertical, longitudinal, lateral andisocentric positioning of the patient	Optional accessory - Vertical motion only forease of lowering patient to the treatmentheight from a comfortable seated position

Usability is being improved by adding functions relevant to contemporary cancer treatment techniques and removing those that are not.

The major components of the Theratron Phoenix, including the head, source mechanism, main frame and base have had minor modifications to accommodate the above changes.

There are no changes to the mechanical structure or radiological shielding of the head.

The irradiation source and radioactivity of the cobalt-60 source remains unchanged as does the source drawer mechanism.

The control system has been designed to meet the same intended use as the current model.

PERFORMANCE DATA

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

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the GammaBeam 500, consisting of the main unit and patient couch. The system complies with the following standards for safety:

0 IEC 60601-1:2013 Edition 3.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Edition 3.0 Medical electrical equipment Part 1-2: General requirements 0 for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
0 EN 60601-2-11:2011 Edition 3.0 Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment
EN 61217 (2014) Radiotherapy equipment Coordinates, movements and scales 0

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

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Mechanical Testing

The performance of the device was tested against a set of functional specifications in an environment that simulated, as much as possible, the actual operating environment. This included:

· Mechanical validation of the main unit and patient couch
· Physics validation
· Simulated use testing

CONCLUSIONS

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the GammaBeam 500 performs as intended in the specified use conditions. The performance data demonstrates that the GammaBeam 500 is as safe and effective as the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 892.5750 Radionuclide radiation therapy system.

(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.