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The needles are used for interstitial placement of gold fiducial markers. Once implanted, the gold fiducial markers are used as localization targets for the process in IMRT, and IGRT radiation therapy.

The Stellar Fiducial Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of a solid gold marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax. The packaged needles are sterilized via ethylene oxide.

This document, K092041, is a 510(k) summary for the Stellar Fiducial Marker, a device used in radiation therapy. The document asserts that the device is substantially equivalent to a predicate device based on its intended use and general characteristics. However, it does not contain the detailed study information typically associated with acceptance criteria and device performance evaluation.

Therefore, I cannot provide the requested information because the provided text does not include any study data, acceptance criteria, or performance metrics beyond a statement of substantial equivalence to a predicate device. The document focuses on regulatory approval rather than technical validation.

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