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The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.

MoldCare Head & Neck Cushion Model # MT-ACL-14242. A Radiographic head holder System to be manufactured by MED-TEC, INC.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Moldcare Head & Neck Cushion. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter explicitly states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a device already on the market, usually without requiring new clinical studies to prove efficacy.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria and validation studies.

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