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The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as a primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, or as a boost to the primary tumor.

The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the completion of external beam radiation therapy or chemotherapy.

EZ-Pak is a packaging change to InterSource 103 (#K973328), InterSource 125 (#K9984235) and InterStrand ® (#K011155). There is no change in the intended use of these cleared sources. Please see the referenced Premarket Notification documents for Statements of Intended Use.

The provided text is a Premarket Notification (Special 510(k) Device Modification) for the "EZ-Pak" device, which is a packaging change to existing brachytherapy sources. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it pertains to a packaging modification rather than a new functional device requiring performance validation.

Therefore, I cannot extract the requested information based on the provided text. The document focuses on establishing substantial equivalence for the packaging modification and maintains the intended use of the previously cleared brachytherapy sources.

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