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The Reliant Charger is used to cause engorgement of the penis for men that are having difficulty with organic or psychological impotence.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Reliant Charger (RC-1)" and its "Indications for Use." This document is a regulatory approval letter and does not contain information about 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 referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was approved based on its substantial equivalence to a predicate device already on the market, not necessarily through a new study demonstrating its efficacy against specific acceptance criteria. The 510(k) process often relies on comparison to existing legally marketed devices rather than requiring de novo clinical trials with predefined acceptance criteria.

Therefore, I cannot provide the requested information for the Reliant Charger (RC-1) based solely on these documents. The information requested (acceptance criteria, performance data, study details, expert qualifications, etc.) is typically found in a clinical study report or a more detailed technical submission, not in the FDA's regulatory approval letter itself.

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