(193 days)
The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The maximum application duration per treatment application is 28 days.
Not Found
I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study that proves the device meets acceptance criteria for the "Martinez Prostate Template Set." The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not detail performance metrics, study design, or results.
Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
§ 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.