(182 days)
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.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).