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Playtex tampons are intended to be used as unscented menstrual tampons for the absorption of menstrual fluid.

Unscented menstrual tampons for the absorption of menstrual fluid. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginat wall are the same or have the same mode of action.

This 510(k) summary describes a new menstrual tampon and compares it to a legally marketed predicate device. The information provided is not about an AI/ML powered device, and therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of N/A for AI/ML criteria: The document describes a physical medical device (a tampon), not an artificial intelligence or machine learning product. Therefore, performance metrics typical for AI/ML devices such as accuracy, sensitivity, specificity, AUC, recall, precision, F1-score, etc., and criteria related to model performance, bias, or generalizability are not relevant or discussed. The acceptance criteria here are based on physicochemical and biological safety testing and a historical comparison to a predicate device for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not specified in the provided summary. Clinical and nonclinical testing was conducted, but the number of subjects or samples for these tests is not detailed.
• Data Provenance: Not explicitly stated, but the testing would have been performed by or for Playtex Products, Inc., likely in their R&D facilities or contracted laboratories. The information does not indicate specific countries of origin for the data (e.g., patient demographics for clinical trials), as this is not a study involving patient data in the typical sense of AI/ML evaluation. The study is prospective in the sense that the testing was performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Experts for Ground Truth: Not applicable in the context of an AI/ML device. For a physical device like a tampon, safety and effectiveness are typically assessed through laboratory tests (e.g., agar diffusion, toxicity tests) and potentially human use studies (e.g., irritation studies). The "ground truth" is established by the results of these tests and their interpretation by qualified scientists/toxicologists/clinicians, not through expert consensus on diagnostic imaging or similar AI/ML applications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers evaluate cases and their discrepancies need to be resolved for ground truth establishment. This is not relevant to physicochemical and biological testing for a tampon.

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:

• MRMC Study: No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: No. This is not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for the safety endpoints (sensitization, toxicity, irritation, TSST-1 toxin) is established by the results of standardized laboratory and biological assays (e.g., positive/negative reaction in sensitization tests, specific toxin levels, observed irritation scores). For effectiveness, the ground truth is indirectly supported by the known performance characteristics of the predicate device and the statement that the new device has the "same technological characteristics." There is no "pathology" or "outcomes data" in the sense of disease diagnosis or patient outcomes beyond the general safety profile.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no "training set." The materials used for manufacturing are specified, and their safety properties are investigated.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable as there is no training set for an AI/ML device. The "ground truth" for the characteristics of the materials used in the manufacturing of the tampon would have been established through material specifications, quality control testing, and adherence to industry standards, not through a "training set" in the AI/ML context.

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