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The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

The Unscented W long plastic and cardboard applicator Tampons are unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of 100% viscose with polymeric overwrap. The applicator is a full size applicator provided in polyethylene or cardboard. The absorbent pledget has a W wadding design and is available in light, regular, super and super plus absorbencies.

I am sorry, but based on the provided text, there is no information about a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for "Unscented W long plastic and cardboard applicator Tampons," which are menstrual tampons, not an AI/ML device. The document discusses performance testing for tampons, such as biocompatibility, absorbency, and microbiological testing, to establish substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information for an AI/ML device, as this document does not pertain to one.

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