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Unscented menstrual tampons for the absorption of menstrual fluid.

Unscented menstrual tampons for the absorption of menstrual fluid.

The provided text describes a 510(k) submission for Playtex Tampons, specifically addressing their substantial equivalence to previously cleared Playtex Gentle Glide Tampons. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states:

• Device Name: Playtex Tampons (Unscented Menstrual Tampons)
• Predicate Device: Previously cleared Playtex Gentle Glide Tampons, Regular, Super and Super Plus.
• Intended Use: Unscented menstrual tampons for the absorption of menstrual fluid.
• Technological Characteristics: The new tampon has the same technological characteristics as the predicate device (fiber, string, materials in contact with the vaginal wall, and mode of action are the same).
• Nonclinical Testing: Dioxin analysis, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing.
• Conclusion: The Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness based on the review of the data.

Therefore, I cannot populate the table or provide information for the specific points you requested, as the document focuses on demonstrating substantial equivalence rather than reporting on specific performance acceptance criteria from a study.

The document indicates that the determination of safety and effectiveness was based on the nonclinical testing mentioned above and a comparison to the predicate device. It does not describe a clinical study with a test set, ground truth, or statistical analysis of performance metrics against predefined acceptance criteria for the new device.

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