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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. The anatomical site is typically the transperineal approach in and around the prostate gland.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "Readi-Strand Model PS-Strand." This document is a regulatory approval letter and does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information from the provided text. The letter only confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

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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.

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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. The anatomical site is typically the transperineal approach in and around the prostate gland.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain any information about acceptance criteria or a study proving the device meets said criteria. The document is a regulatory approval for the World Wide Medical Technologies ReadiStrand Model PSStrand, a radionuclide brachytherapy source carrier.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer any of the subsequent detailed questions about the study, as this information is not present in the provided text.

Ask a specific question about this device