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The intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

Worldwide Medical Technologies Seed Implant Needle Set

The provided documents are a 510(k) premarket notification letter from the FDA and an "Indications For Use" statement for the "Worldwide Medical Technologies Seed Implant Needle Set." These documents relate to the regulatory clearance of a medical device and do not contain information about acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from these documents.

The documents primarily confirm that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. They do not detail the specific studies or data used to establish device performance against defined criteria.

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