(79 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 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.
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.
§ 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.