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The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.

The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid

The provided text is a 510(k) clearance letter from the FDA for the NIT Needle Guiding Template (Seed Applicator). It is a regulatory document confirming substantial equivalence to a predicate device, which allows the company to market the device.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent...". This means the clearance is based on the device being similar enough to an already approved device, rather than requiring new performance studies meeting specific acceptance criteria as would be needed for a novel device or pre-market approval (PMA).

Therefore, I cannot fulfill your request for the tables and information about the study, as the provided text does not contain this data.

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