(30 days)
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.
The Theratron Elite 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 devices Theratron 780E and 1000E. The key difference is that the 'push-button' style control console on the predicate devices has been replaced with a modern PC based remote control console with graphic user interface and 'Record and Verify' communication capability.
The provided text describes a medical device, the Theratron Elite, which is a Cobalt Teletherapy device. The 510(k) summary indicates that the device's development and validation are in compliance with Theratronics product development procedures and that the validation demonstrates the device meets its published specifications.
However, the provided documentation does not contain specific acceptance criteria values or detailed results from a study proving these criteria were met. It only states a general conclusion that the device performs "as well or better than the predicate device."
Therefore, I cannot populate sections 1 through 9 of your request with specific numbers or detailed methodological descriptions because the information is not present in the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with quantifiable thresholds. The summary mentions "published specifications" but does not detail them.
- Reported Device Performance: Not explicitly stated with quantifiable metrics. The summary states it "performs as well or better than the predicate device" (Theratron 780E and 1000E).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set or ground truth establishment process is described for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set or ground truth establishment process is described for performance evaluation.
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 Cobalt Teletherapy device, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers." The primary comparison is to a predicate device's technical specifications and performance in delivering radiation, not human reading performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is more relevant to AI-driven diagnostic tools. For a radiation therapy device, the performance is inherently "standalone" in terms of its mechanical and radiation delivery capabilities. The device's "performance" would be related to accuracy of dose delivery, beam shaping, and safety controls, which would be tested without human "interpretation" in the loop beyond operational controls. The text mentions "development and validation" but doesn't detail the studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic interpretation. For a radiation therapy device, "ground truth" would relate to manufacturing specifications, radiation physics parameters, safety standards, and potentially clinical outcomes if a clinical trial were conducted. The document states "device meets its published specifications," implying engineering and physics testing against known standards.
8. The sample size for the training set:
- Not applicable as this is not an AI/machine learning device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/machine learning device.
Conclusion based on the provided text:
The 510(k) summary for the Theratron Elite primarily focuses on establishing substantial equivalence to predicate devices (Theratron 780E and 1000E) based on its design, intended use, and general performance claims. It states that "The validation demonstrates that the device meets its published specifications, performs as well or better than the predicate device to which it is substantially equivalent, and is safe and effective for its intended use." However, it does not provide the specific data, metrics, or detailed study methodology that would allow for a comprehensive answer to your questions regarding acceptance criteria and performance study details.
§ 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.