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Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.

Scented, deodorized menstrual tampons for the absorption of menstrual fluid.

This document describes the 510(k) summary for Playtex Tampons, specifically scented, deodorized menstrual tampons. The submission aims to demonstrate substantial equivalence to previously cleared Playtex tampon models.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

   Acceptance Criteria	Reported Device Performance
   Substantial equivalence to predicate devices regarding safety and effectiveness.	Playtex tampons are reported to be substantially equivalent to the predicate devices (Playtex Deodorant Gentle Glide®, Playtex Deodorant Portables®, Playtex Deodorant Gentle Glide Multipack, and Deodorant Slimfits®) in terms of safety and effectiveness. This determination is based on a review of referenced nonclinical testing data. The new tampon has the same technological characteristics as the predicate devices, with the fiber, string, and materials in contact with the vaginal wall being the same or having the same mode of action. The device is intended for the same use: scented, deodorized menstrual tampons for the absorption of menstrual fluid.
   Nonclinical testing (Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing) to support safety.	Nonclinical testing referenced for the determination of substantial equivalence includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing. (Specific results or thresholds for these tests are not provided in the summary, only that they were referenced and support substantial equivalence.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   The document does not specify a "test set" in the context of a clinical study with human subjects. The supporting data for substantial equivalence is based on nonclinical testing. Therefore, information regarding sample size, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   As the data relies on nonclinical testing rather than human subject data requiring ground truth established by experts (like radiologists for imaging devices), this information is not applicable to this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   Given that the supporting data is from nonclinical laboratory tests instead of a clinical test set, an adjudication method for a test set is 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:

   This submission is for a medical device (tampons) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not applicable.

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

   This submission is for a medical device (tampons) and does not involve an algorithm. Therefore, a standalone performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   For this device, the "ground truth" for demonstrating safety and effectiveness stems from the results of the nonclinical laboratory tests (human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing) in comparison to the same tests performed on the predicate devices. The "ground truth" is that the new device performs equivalently in these specific tests to the predicate devices, which are already considered safe and effective.

8. The sample size for the training set:

   This submission does not involve an algorithm or an AI system that requires a "training set." Therefore, this information is not applicable.

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

   Given that no training set for an algorithm is involved, this information is not applicable.

Summary of Device and Acceptance Criteria Fulfilment:

The core of this 510(k) submission is to demonstrate substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria relate to showing that the new Playtex Tampons have the "same technological characteristics" and achieve equivalent safety and effectiveness based on nonclinical testing. The study supporting this is a comparison of these nonclinical tests between the new device and the predicate devices. The summary states that these tests were "referenced" and support the conclusion of substantial equivalence. No clinical studies in human subjects with specific performance metrics (like sensitivity, specificity, accuracy) were provided or required for this type of device and submission pathway.

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