(93 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 100 is a radiotherapy treatment unit with a cobalt-60 radiation delivery system. The device consists of a source head, collimator, gantry, main frame, base, controls and a pendulum or beamstopper style counterweight. The design of this device is substantially equivalent to predicate device Theratron Phoenix.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any statistical measures.
The document is a 510(k) premarket notification letter from the FDA to Best Theratronics Limited regarding their "Gammabeam 100" device (a Radionuclide radiation therapy system). It primarily states that the device has been found substantially equivalent to a legally marketed predicate device (Theratron Phoenix).
The document mentions:
- Safety & Effectiveness: It states that "The safety of the GammaBeam 100 is equivalent or better than the predicate device" and that "Validation testing demonstrated that the device is as safe and effective as the predicate device."
- Compliance with Standards: It lists several IEC and EN standards that the device is designed to comply with (e.g., IEC 60601-1-2, IEC 60601-1, EN 60601-2-11, EN 61217).
- Functional Specifications: It vaguely mentions "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."
However, it does not provide:
- A table of acceptance criteria and reported device performance (with specific metrics).
- Sample sizes or data provenance for a test set.
- Information about experts, ground truth establishment, or adjudication methods for a test set.
- Details on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details on a standalone algorithm performance study.
- The type of ground truth used (beyond implying functionality and safety against standards).
- Sample size for a training set or how its ground truth was established.
This document is a regulatory approval letter based on substantial equivalence, not a detailed study report providing performance metrics against quantitative acceptance criteria.
§ 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.