(30 days)
The intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
The GammaMed Plus is a transportable high-dose-rate remotely controlled afterloading brachytherapy device. The unit is designed to provide a predetermined dose of radiation to tissues and organs by means of manipulating a radioactive source from a shielded position within the device into an applicator, which has been previously placed within or on a patient. The GammaMed plus system is based on a further development of the existing GammaMed 12it system. The GammaMed plus system consists of the following components: Treatment device including computer and control software, Applicators and accessories, Treatment planning system.
This document is a 510(k) summary for the GammaMed Plus High Dose Rate Remote Afterloading System. It outlines the device's characteristics, intended use, and its substantial equivalence to a legally marketed predicate device (GammaMed 12it).
However, the provided text does not include any information about acceptance criteria, device performance, or a study conducted to prove the device meets said criteria. The document focuses on regulatory approval based on substantial equivalence, primarily by describing engineering changes and stating that these changes do not adversely affect safety or effectiveness.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.