(114 days)
The Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons, Available in light, regular, super, and super plus absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
The Ontex Tampons are:
-
- Unscented Digital
- Unscented Plastic Applicator 2)
-
- Unscented Cardboard Applicator
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (
The provided text describes a 510(k) premarket notification for Ontex tampons and does not contain information about an AI-powered device or a study involving acceptance criteria in the context of device performance metrics like sensitivity, specificity, or F1 score.
Instead, the document details the substantial equivalence determination for a medical device (tampons) based on comparisons to a predicate device and assessments of performance standards and non-clinical testing for safety and effectiveness.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a physical medical device, not an AI/ML-powered diagnostic or assistive technology.
§ 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).