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The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.

The W long plastic applicator Tampons are conventional unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of organic cotton. The applicator is in polyethylene and of full size (long). The pledget has a W wadding design. The Tampons are available in regular and super absorbencies.

This document is a 510(k) premarket notification for a medical device, specifically tampons. It does not describe an acceptance criteria or a study that proves a device (like an AI/ML algorithm) meets acceptance criteria.

The document is a regulatory submission to the FDA to demonstrate that a new device ("W long plastic applicator Tampons") is substantially equivalent to a legally marketed predicate device ("Ontex Tampon (Unscented)"). This process is for conventional medical devices, not AI/ML systems.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or how training ground truth was established) from this document because it pertains to a different type of device and regulatory approval process.

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The Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons, Available in light, regular, super, and super plus absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.

The Ontex Tampons are:

• 1. Unscented Digital
• Unscented Plastic Applicator 2)
• 3. Unscented Cardboard Applicator

Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.

These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (

The provided text describes a 510(k) premarket notification for Ontex tampons and does not contain information about an AI-powered device or a study involving acceptance criteria in the context of device performance metrics like sensitivity, specificity, or F1 score.

Instead, the document details the substantial equivalence determination for a medical device (tampons) based on comparisons to a predicate device and assessments of performance standards and non-clinical testing for safety and effectiveness.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a physical medical device, not an AI/ML-powered diagnostic or assistive technology.

Ask a specific question about this device