(299 days)
The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures.
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This document is a 510(k) clearance letter for the "Readi-Strand Model PSStrand" device, which is a radionuclide brachytherapy source carrier. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has reviewed Worldwide Medical Technologies, Inc.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the device's indications for use: "to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland."
To answer your specific questions, information regarding acceptance criteria, device performance results, study design details (sample size, data provenance, expert qualifications, adjudication methods, etc.), and ground truth establishment would typically be found in the 510(k) summary submitted by the manufacturer, which is a separate document from this clearance letter.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.