(200 days)
The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.
Not Found
This looks like an FDA 510(k) clearance letter and an 'Indications For Use' statement, not a study report. This type of document generally does not contain the information requested regarding acceptance criteria, device performance results, study design details, or ground truth establishment.
A 510(k) clearance letter indicates that the FDA has found a device to be substantially equivalent to a predicate device already on the market, meaning it's as safe and effective as the predicate. It does not typically involve the submission of detailed performance studies against pre-defined acceptance criteria in the same way a Premarket Approval (PMA) would.
Therefore, I cannot provide the requested information from the given input.
§ 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.