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The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (12-15g). Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided document is a 510(k) Premarket Notification for menstrual tampons. It does not contain information about a study proving that a device meets acceptance criteria in the context of an AI/ML medical device. The document describes non-clinical testing for physical and biological properties of tampons and states that "all samples met the predefined acceptance criteria," but it does not detail those acceptance criteria or performance metrics for a software or AI device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to AI/ML. The provided text is about a physical medical device (tampon) and its safety and effectiveness, not an AI/ML device.

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