(154 days)
The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.
The W long plastic applicator Tampons are conventional unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of organic cotton. The applicator is in polyethylene and of full size (long). The pledget has a W wadding design. The Tampons are available in regular and super absorbencies.
This document is a 510(k) premarket notification for a medical device, specifically tampons. It does not describe an acceptance criteria or a study that proves a device (like an AI/ML algorithm) meets acceptance criteria.
The document is a regulatory submission to the FDA to demonstrate that a new device ("W long plastic applicator Tampons") is substantially equivalent to a legally marketed predicate device ("Ontex Tampon (Unscented)"). This process is for conventional medical devices, not AI/ML systems.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or how training ground truth was established) from this document because it pertains to a different type of device and regulatory approval process.
§ 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).