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EpiScreen is intended to collect oral fluid specimens, contain those specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

The EpiScreen device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common (Specifical vial). The Generativertonic environment which produces an osmotic sails and gelain, ereating a my perival mucosae. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow the gingival macoba (between was sorptive cotton fibers of the pad. Following the of Indecourt the Collection Pad is removed from the mouth and placed into a conection period, the Concession a preservative solution which serves to inhibit the Specifical The The Tim connect on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) summary for the EpiScreen™ Oral Specimen Collection Device. It describes the device, its intended use, classification, and states that a modification was made to the package insert of an already cleared device (K970357). The core claim is that the modified device is identical to the currently cleared device and therefore does not raise new questions of safety and efficacy.

Consequently, none of the requested information (acceptance criteria table, sample size, data provenance, expert details, adjudication method, MRMC study, standalone performance, ground truth types, training set size, or ground truth establishment for training set) can be extracted from the provided text. The document focuses on regulatory equivalence rather than performance studies against defined acceptance criteria.

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