(84 days)
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.
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.
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.
§ 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.