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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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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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Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.

The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or without polyethylene/polyester cover and a withdrawal cord. These tampons will be provided as three absorbencies: regular, super and super plus.

Each non applicator organic cotton tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

Each compact applicator organic cotton tampon is inserted into a plastic compact applicator and wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

The provided document is a 510(k) summary for Cotton High Tech S.L.'s organic cotton tampons. It details the device's characteristics, intended use, and a summary of non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain the specific information requested about acceptance criteria for a device, nor does it describe a study that proves the device meets those criteria in the way envisioned for a diagnostic or AI-powered medical device.

The document discusses performance data related to the physical and biological properties of the tampons (e.g., absorbency, biocompatibility, microbiology), but it does not present these in the format of acceptance criteria with reported device performance in a table, nor does it involve the concepts of ground truth, expert consensus, MRMC studies, or training sets typical for AI/diagnostic device evaluations.

Therefore, I cannot fulfill your request with the provided input text in the format you've specified because the information is not present in the document. This document is a regulatory submission for a medical device that is a physical product (menstrual tampons), not a diagnostic or AI-driven system.

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Organic Essentials Organically Grown Cotton Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

Organic Cotton Tampon

This is a letter about the clearance of the Organic Essentials Organic Cotton Tampon, a Class II medical device. The provided text is a 510(k) clearance letter and an "Indications for Use" statement.

Unfortunately, this type of document does not contain the information requested in your prompt regarding acceptance criteria, study results, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria like those described in your prompt.

Therefore, I cannot extract the requested information from the provided text.

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