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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:

• 1. Unscented Digital
• Unscented Plastic Applicator 2)
• 3. 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 (<6g), regular (6-9g), super, (9-12g), and super plus (12-15g)

These Tampons are made from viscose and/or cotton cellulosic material and polymeric overwrap and cotton or cotton polyester cord. Applicators are either polyethylene or polypropylene.

The materials used in these tampons are similar to those used in other legally marketed tampons..

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.

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