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Maxim Hygiene Organically Grown Cotton Tampon is a tampon used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.

A tampon is used for internally absorbing menstrual flow during a period. A range of absorbencies are available designed to cope with various menstrual flows which differ not only from woman to woman, but also during a woman's menstrual life and during each period.

The provided text describes a 510(k) submission for the Maxim Hygiene Organically Grown Cotton Tampon. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving human subjects or AI algorithms. As such, many of the requested elements for an AI/device performance study are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on physicochemical properties and dimensions matching those of predicate devices. The "reported device performance" is effectively the measured values for the Maxim Hygiene tampon, which are shown to be within the ranges of the predicate devices.

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

The document does not specify a "test set" in the context of an AI or clinical study. The testing performed ("Determination of Absorbency Rate of Tampons - Syngina Test", "Expulsion Force Applicator Tampons", "Fiber Loss ATS Testing Method", "Stability Check on Digital Tampons") would have involved a sample of tampons for physical and absorption testing. The sample size for these specific tests is not provided.

Data provenance is not applicable in the sense of patient data; it refers to the physical tampons manufactured by Maxim Hygiene.

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

This is not applicable as there is no "ground truth" derived from expert review in this type of submission. The ground truth for physical properties is derived from standardized testing methods.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is a medical device for menstrual fluid absorption, not a diagnostic AI device requiring human reader performance studies.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

The "ground truth" for this device is based on physical and chemical properties measured against established standards and validated by comparison to legally marketed predicate devices. This includes:

• Syngina Absorption: A standardized laboratory test to measure absorbency.
• Dimensions and Weight: Direct physical measurements.
• Material Composition: Stated as 100% organic cotton, assumed to be verified through material analysis.
• Biocompatibility: Demonstrated by reference to predicate devices (K983478 and K914430), implying that the materials used are biocompatible as per those previous clearances.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable.

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