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 Theratron Equinox consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beam-stopper style counterweight. The design of this device is similar to predicate device Theratron Elite 80 and 100.

AI/ML Overview

The provided document describes the MDS Nordion Theratron Equinox 80 and 100, which are Cobalt Teletherapy Devices. The submission is a 510(k) for substantial equivalence to a predicate device, the Theratron Elite 80 and 100. The device is a "Radionuclide Radiation Therapy System" intended for delivering gamma radiation for cancer treatment.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria in terms of numerical performance thresholds for the device. Instead, the acceptance criteria are implicitly defined by compliance with a set of international safety and performance standards for medical electrical equipment and radiotherapy devices, and by demonstrating equivalence to the predicate device.

The reported device performance primarily focuses on the design changes and equivalence to the predicate device, rather than new quantitative performance metrics for the Theratron Equinox itself.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with EN 60601-1 (1995)	The Theratron Equinox 80 and 100 are designed to comply with this standard for general requirements for safety of medical electrical equipment.
Compliance with EN 60601-1-2 (2004)	The Theratron Equinox 80 and 100 are designed to comply with this standard for electromagnetic compatibility.
Compliance with EN 60601-1-4 (2001)	The Theratron Equinox 80 and 100 are designed to comply with this standard for programmable electrical medical systems.
Compliance with EN 60601-2-11 (2004)	The Theratron Equinox 80 and 100 are designed to comply with this standard for particular requirements for the safety of gamma beam therapy equipment.
Compliance with EN 61217 (2000)	The Theratron Equinox 80 and 100 are designed to comply with this standard for radiotherapy equipment coordinates, movements, and scales.
Safety equivalence to predicate device (Theratron Elite)	The safety of the Theratron Equinox 80 and 100 is stated to be "equivalent or better than the predicate device."
Effectiveness equivalence to predicate device (Theratron Elite)	The document states, "Validation testing demonstrated that the device is as safe and effective as the predicate device." The changes implemented (new control system, parameter display, control panel, GUI, hand control, covers, collision detection, asymmetric jaws, motorized wedge, in-room display) are presented as additional functionality or modern appearances that do not change the intended use or the core mechanical/radiological aspects of delivering radiation, which are derived from the predicate. The irradiation source, radioactivity, and source drawer mechanism remain unchanged. The control system is designed to meet the same intended use.
Performance against functional specifications	"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." (Specific functional specifications are not detailed in this summary).

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

The document does not provide details on a "test set" in the context of patient data or clinical images for algorithm performance. This is a 510(k) submission for a physical radiotherapy device, not an AI/software as a medical device (SaMD) that typically involves diagnostic or prognostic algorithms.

The "testing" mentioned refers to engineering verification and validation of the device's functional specifications and safety compliance. The data provenance would be internal engineering test data generated during the device's development and testing phases, presumably in Canada (MDS Nordion is based in Ottawa, Ontario) and is prospective testing against design requirements.

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

This information is not applicable in the context of this 510(k) submission. The ground truth for this type of device (a radiation therapy machine) is established through engineering design specifications, adherence to international standards, and physical measurements of performance (e.g., radiation output accuracy, gantry movement precision, safety mechanism functionality) conducted by engineers and physicists, not by medical experts interpreting clinical data.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here. This method is typically used in clinical studies where multiple human readers independently assess data, and a consensus or tie-breaking mechanism is needed for ground truth establishment. For a physical device like a teletherapy unit, performance is objectively measured against pre-defined engineering and safety criteria.

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

An MRMC comparative effectiveness study is not applicable to this device. This type of study assesses the impact of AI on human diagnostic or interpretative performance. The Theratron Equinox is a treatment delivery device, not a diagnostic tool or an AI assistant for human readers.

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

A standalone algorithm performance study is not applicable to this device. While the device contains a control system and GUI, it is not an "algorithm-only" device intended for diagnostic or predictive functions. It is a machine that performs a physical action (delivering radiation) under human operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance would be established through:

Engineering Specifications: The design parameters the device is intended to meet (e.g., dose accuracy, mechanical precision, safety interlock response times).
International Standards: Compliance with the enumerated EN 60601 and EN 61217 standards serves as a benchmark for safety and performance.
Physical Measurements: Direct measurements taken during manufacturing and testing to verify that the device meets its specifications (e.g., using dosimeters to measure radiation output, calipers/sensors to measure gantry/collimator movement accuracy).
Predicate Device Performance: The predicate device, Theratron Elite, serves as a de facto "ground truth" for acceptable performance for this class of device, given the 510(k) pathway for substantial equivalence.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning is not applicable to this device. The device's control system and operational logic are developed through traditional software engineering and hardware design, not by training an AI model on a dataset.

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

As stated above, the concept of a "training set" is not applicable here. The "ground truth" for the device's functional design and safety is established through engineering principles, regulatory standards, and validated manufacturing processes.

Summary

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MAR 9 2006

K053485

510(k) SUMMARY

Date Summary Prepared	December 7, 2005
Submitted by	MDS Nordion447 March RoadOttawa, Ontario K2K 1X8CanadaTel. (613) 592-3400Fax. (613) 592-2006
Contact Person	Mr. Ross KachaniwskyDirector, Quality & Regulatory Affairs
Device Name	Theratron Equinox 80Theratron Equinox 100
Common Name	Cobalt Teletherapy Device
Classification Name	Radionuclide Radiation Therapy System
Legally Marketed Predicate Device	Theratron Elite 80 and 100

Description of Device

Intended Use of Device

The unit is intended to be used in:

Delivering the intended dose at a specified position; .
Delivering the radiation in accordance with the selected relationship of the radiation to the patient . (fixed or moving beam therapy, beam modifying device, etc.);
. Delivering the radiation without causing unnecessary risk to the patient, the operator, other persons, or the immediate environment.

Summary of Technological Characteristics

The Theratron Equinox 80 and 100 is substantially equivalent to the predicate device (K983917).

The design change is to provide a new 'modern' appearance to the previous design using existing major components of the predicate device, and adds some new functionality that allows customers to treat patients with modern radiotherapy techniques while not changing the intended use of the device.

Changes include a new:

· Control System: the system is easy to maintain and diagnosis of problems is automated as much as possible
· Parameter Display: for displaying all gantry and collimator parameters relevant to treatment setup
· Control Panel: providing all hardware links to the unit that cannot be software controlled by the User Interface e.g. emergency stop
. Graphic User Interface: providing for efficient treatment setup and execution
· Hand Control modified for modern appearance and ergonomic improvement over previous design

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· Covers: The unit has a more modern appearance
· Collision Detection Device -- stops motion of the gantry when a collision is detected
· Asymmetric jaws collimator X and Y jaws can move independently
· Motorized wedge -- a wedge affixed to the inside of the collimator can be moved to the in or out position
· In-room display monitors

The major components of the Theratron Elite, including the head, gantry, main frame, base, and pendulum/beam stopper counterweight 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.

Safety & Effectiveness

The safety of the Theratron Equinox 80 and 100 is equivalent or better than the predicate device.

In terms of safety, the Theratron Equinox 80 and 100 are designed to comply with

EN 60601-1 (1995), Medical Electrical Equipment. Part 1; General requirements for safety, and .
EN 60601-1-2 (2004), Medical Electrical Equipment, Part 1;General requirements for safety; . Electromagnetic Compatibility - Requirements for Tests
EN 60601-1-4 (2001) Medical electrical equipment Part 1-4: General requirements for safety -. Collateral Standard: Programmable electrical medical systems
EN 60601-2-11 (2004) Medical electrical equipment Part 2: Particular requirements for the safety of . qamma beam therapy equipment
EN 61217 (2000) Radiotherapy equipment -- Coordinates, movements and scales .

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. Validation testing demonstrated that the device is as safe and effective as the predicate device.

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Public Heatth Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 9

2000

Mr. Ross Kachaniwsky Director, Quality Assurance MDS Nordion 447 March Road Ottawa, ON K2K 1X8 CANADA

Re: K053485 Trade/Device Name: Theratron Equinox 80 and Theratron Equinox 100 Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB Dated: February 3, 2006 Received: February 7, 2006

Dear Mr. Kachaniwsky:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Nancy C. Brigeton

Naney C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number: K053485

Device Name:

Theratron Equinox 80 Theratron Equinox 100

Indications For Use:

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.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

Nancy C. Broxton
Division Sign-Off

Jivision Sign-Off) / Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.