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The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.

Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.

The provided text is a 510(k) summary for the "VariSource Wright Vaginal Cuff Applicator" and does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information. It appears the document is not a performance study report but rather regulatory submission for market clearance based on substantial equivalence.

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