(25 days)
The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.
The Akesis Galaxy RTx, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position.
The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient's head is immobilized in a headframe which has been fitted prior to the commencement of treatment. The entire system consists of a) the y-ray treatment unit, and b) the stereotactic localization system.
The provided text describes the 510(k) premarket notification for the Akesis Galaxy RTx, a radionuclide radiation therapy system. It details the device's technical characteristics, its comparison to a predicate device, and various performance data submitted in support of its substantial equivalence.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance for diagnostic or assistive functions related to image analysis or data processing. The device described is a physical radiation therapy system, and the performance data pertains to its safety, electrical compatibility, hardware/software verification, and its ability to meet specifications for radiation delivery.
Therefore, I cannot provide the requested information for an AI/ML device, as the provided text relates to a different type of medical device for radiation therapy.
If you have information about an AI/ML device and its associated acceptance criteria and study data, please provide that text.
§ 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.