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COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. It will be provided on light absorbency (6g and under). Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.

This document describes a 510(k) premarket notification for COHITECH Organic Cotton Cardboard Applicator Tampons Light. The submission seeks to add a "light" absorbency version to an existing family of tampons (Regular, Super, and Super Plus) previously cleared under K091084.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a single table with acceptance criteria and reported device performance side-by-side. Instead, it lists the performance characteristics assessed and implies that these assessments met predetermined acceptance criteria based on the 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)".

Performance Characteristics Assessed (Implied Acceptance Criteria Met):

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the sample sizes for the performance tests (dimensions, absorbency, withdrawal cord strength, fiber shedding, or microbiology testing). It refers to "verification activities" and "testing on the subject device."
• Data Provenance: The document does not specify the country of origin for the data. The studies appear to be retrospective in the sense that they are conducted to demonstrate equivalence for regulatory approval, rather than being part of an ongoing clinical trial. The microbiology testing includes data on the "subject device," indicating it was specifically tested. For biocompatibility, reliance was placed on prior testing from K091084, with a certification that materials are the same.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device (menstrual tampons). The "ground truth" here is defined by established engineering and microbiological performance standards and guidance documents (e.g., 2005 FDA guidance "Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)"). There are no "experts" in the sense of clinical reviewers establishing a diagnostic ground truth, but rather testing engineers and microbiologists performing standardized tests.

4. Adjudication method for the test set:

This is not applicable as it's not a diagnostic device involving human interpretation. The "adjudication" is based on comparing test results against predefined thresholds in established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This is not an AI/CAD device. It is a physical medical device (menstrual tampon).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on:

• Established industry standards and regulatory guidance: Specifically, the "2005 FDA guidance 'Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)'". This guidance outlines the required performance characteristics and likely specifies the methodology and acceptable ranges for these tests.
• Predicate device characteristics: The subject device is compared to a legally marketed predicate device (Maxim menstrual tampons and Organyc menstrual tampons, K091084). The "ground truth" for the predicate device's safety and effectiveness was established during its own clearance process, and the subject device aims to demonstrate substantial equivalence to this established benchmark.

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable. There is no training set for this device.

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