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The Naturalena 100% Cotton Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

The provided text describes a 510(k) summary for a menstrual tampon and a clearance letter from the FDA. This submission is for a medical device that does not involve an algorithm or AI. Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria in the context of AI performance.

The document discusses substantial equivalence to predicate devices based on technological characteristics and intended use for a physical product (menstrual tampon), not a software or AI-driven diagnostic or therapeutic device. Key characteristics like absorbency and materials are mentioned, but these are not evaluated through the types of studies listed in your request (e.g., MRMC, standalone algorithm performance, ground truth establishment with experts).

Therefore, I cannot provide the requested information for an AI-based device based on this input.

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