(220 days)
A Cobalt Teletherapy unit is a device by which gamma radiation is delivered for the A Cobalt Teletherapy and is a do not of health care professionals in a radiation therapy clinic.
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 780E consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is similar as the predicate device Theratron 780C with improved safety features and radiation shielding in the collimator area of the unit head assembly.
The provided text describes a 510(k) premarket notification for the Theratron 780E, a Cobalt Teletherapy device. The submission focuses on demonstrating substantial equivalence to a predicate device (Theratron 780C) and mentions general compliance with product development procedures.
However, the document does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, ground truth establishment, or sample sizes for an AI/device performance study. The provided text is a regulatory summary and approval letter, not a clinical or performance evaluation report.
Based on the provided text, I can only state that:
- No acceptance criteria or device performance table is provided. The document states "The validation demontrates 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," but no specific metrics or targets are given.
- No specific study is described that details how the device meets acceptance criteria. The document refers to "Theratronics product development procedures" and "validation" but does not provide details on study design, sample sizes, or data provenance.
- The document does not describe a test set, training set, or how ground truth was established.
- There is no mention of experts, adjudication methods, MRMC studies, or standalone performance.
- The device description and intended use indicate this is a hardware device (radiation therapy system), not an AI/software device that would typically undergo the type of performance evaluation you are asking about. The questions you've posed (e.g., sample size for test set, number of experts, MRMC, standalone performance, training set size) are highly relevant for AI/machine learning medical devices, but not for a device like the Theratron 780E, which is a physical radiation therapy unit.
Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The information is simply not present in this regulatory submission.
§ 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.