(2 days)
The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.
The Gammamed 212 and 232 Source Assemblies are brachytherapy sources that are used in conjunction with Gammamed remote afterloaders. The Gammamed 212 Source Assembly is used in conjunction with the Gammamed 12i or 12it temote afterloader. The Gammamed 232 Source Assembly is used with either the Gammamed Plus or Gammamed 3/24 afterloader.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification for the Gammamed 212 and 232 Source Assembly, focusing on administrative details, device description, and a comparison to a substantially equivalent device. It details the regulatory approval process but does not include clinical study data or performance metrics. Therefore, I cannot generate the requested table and accompanying study information.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.