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The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

The organic cotton tampon and viscose tampon are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The organic cotton tampon and viscose tampon, both have two types i.e., digital tampon and applicator tampon. The tampon applicator is available in two colors - milky and pink. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget ("absorbent core") surrounded by polyethylene and polyethylene terephthalate overwrap ("security veil"), a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The applicator is made of polyethylene and polypropylene. The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both, organic cotton tampon and viscose tampon, are provided in 4 absorbencies: light (≤6g), regular (69g), super (912g) and super plus (12~15g). Each device is individually wrapped in a polyethylene/nonwoven laminated film or cellophane film and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.

The provided text is a 510(k) Summary for a medical device (tampon). It details performance testing, biocompatibility testing, and microbiology testing, but does not describe an AI/ML-based device or a study that uses AI/ML.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and studies that prove an AI device meets those criteria.

The information typically provided in such a document for a traditional medical device (like a tampon) focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized standards and guidance, not on AI/ML performance metrics.

Specifically, the document states:

• No AI: The device is an "Organic cotton tampon" and "Viscose tampon," with no mention of AI or machine learning.
• No clinical study: "No clinical study is included in this submission."
• Non-clinical testing only: The document summarizes "Non-clinical Testing" including performance, biocompatibility, and microbiology tests.

If you have a document describing an AI/ML medical device, please provide that, and I would be happy to analyze it according to your requested criteria.

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