(223 days)
TAMPAX® Pearl Plastic Applicator Tampons, Ultra Absorbency (unscented and scented) are menstrual tampons that are inserted into the vagina and used to absorb the heaviest menstrual flow. Ultra absorbency should not be used on days of light or moderate flow.
The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and a plastic applicator. It is available in both scented and unscented versions.
- The absorbent pledget consists of a chevron-shaped pad of cotton and/or rayon fibers. The pad is overwrapped with a non-woven fabric. A cotton withdrawal cord with absorbent rayon fibers adjacent to the pad is sewn to the pad. For scented tampons, fragrance is applied to the pad. For both scented and unscented tampons, the pad is compressed into a traditional bullet-shaped pledget.
- The formed pledget is inserted into a plastic applicator consisting of an outer insertion tube and an inner pusher tube. Flexible petals form a closed, rounded tip at the distal end of the outer applicator tube.
- Each tampon is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.
The provided text describes a 510(k) submission for a menstrual tampon and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of AI/ML or medical imaging devices. The document is a regulatory approval for a physical medical device (tampons).
Therefore, I cannot provide the requested table and study details as they are not present in the given input. The document focuses on the substantial equivalence of the new tampon device to previously approved predicate devices, primarily in terms of safety and effectiveness related to absorbency and material characteristics, not AI/ML performance.
To answer your request, the input would need to describe a study evaluating the performance of a device (likely an AI/ML or diagnostic device) against predefined acceptance criteria, including details about the study design, sample sizes, ground truth establishment, expert involvement, and statistical analysis.
§ 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).