(108 days)
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.
Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies: Light:
This document does not contain information about an AI/ML medical device. Instead, it is a 510(k) premarket notification for a menstrual tampon (Interlude 100% Cotton Tampon).
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth establishment, or sample sizes related to an AI/ML device. The document details the assessment of the tampon based on physical characteristics, absorbency, chemical residues, microbiology, and biocompatibility, as per FDA guidance for menstrual tampons.
§ 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).