(89 days)
The OUR Rotafing Gamma System is a teletherapy device intended to be used for the stereotactic irradiation of intracranial structures.
The OUR Rotating Gamma System is a teletherapy device which contains 30 60 Co sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built-in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the 600 y-ray beams during treatment, 30 nonoverlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The y-ray treatment unit, b) the stereotactic localization system, and c) the treatment planning system.
To ensure mechanical safety, the system uses redundant limit switches to detect the positions of the doors, and the couch. Low torque motors are used such that all motions can be stopped by one hand. Electrical safety is ensured by use 24VDC power in the entire treatment unit with multiple current limiting breakers. Redundant timing devices are used for treatment timing accuracy. The novel radiation shutter reduces transient radiation exposure to patient's normal structures and adds radiation safety.
This is a pre-amendment device submission from 1997. The concept of acceptance criteria and device performance evaluation as we understand it for AI/ML devices today did not exist at that time. The submission focuses on substantial equivalence to predicate devices based on intended use, performance specifications, materials, and technical characteristics, particularly regarding mechanical, electrical, and radiation safety.
Therefore, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training) is not applicable to this document. The provided text does not contain any of this information.
The submission is primarily concerned with establishing that the "OUR Rotating Gamma System" is substantially equivalent to existing cleared devices (Leksell Gamma Unit Model 23004 and Philips SRS-200 system) for the treatment of selected intracranial abnormalities. The safety summary discusses mechanical and electrical safety measures, and radiation safety, but does not present a study with quantitative acceptance criteria as would be expected for a performance claim.
§ 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.