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

Device Description

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

AI/ML Overview

The provided text describes a 510(k) submission for Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons. It details the device, its intended use, technological characteristics, and conformity to absorbency regulations. However, it does not contain specific acceptance criteria for a device's performance metrics (like sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in the way typically found for AI/medical imaging devices.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and compliance with absorbency regulations for tampons.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's how the available information maps to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric Category	Acceptance Criteria (as per document)	Reported Device Performance
Biocompatibility	All device input requirements for biocompatibility (Cytotoxicity, acute systemic toxicity, vaginal irritation, dermal irritation, allergic contact sensitization, microbial agar diffusion, TSST-1).	"Biocompatibility and Performance Data: Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1), and a clinical study [double-blind, randomized, comparative in-use evaluation of tampon products for overall safety and effect on the vaginal micro flora] testing indicate that the modified device meets all device input requirements."
Absorbency Level	Compliance with "Ultra absorbency" as set forth in 21 C.F.R. § 801.430(e)(1), "User Labeling for Menstrual Tampons."	"The new scented and unscented tampons are in compliance with the requirements for Ultra absorbency as set forth in 21 C.F.R. § 801.430(e)(1), 'User Labeling for Menstrual Tampons.'"
Vaginal Micro Flora	Overall safety and effect on the vaginal micro flora (implied to be comparable to predicate devices).	"a clinical study [double-blind, randomized, comparative in-use evaluation of tampon products for overall safety and effect on the vaginal micro flora] testing indicate that the modified device meets all device input requirements."

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

Sample size for test set: Not explicitly stated for biocompatibility or absorbency tests.
Data provenance: Not specified (e.g., country of origin). The clinical study is described as a "double-blind, randomized, comparative in-use evaluation." This implies prospective data collection, but no specifics on location or demographics are provided.

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

Not applicable as the device is not an AI/diagnostic device. Ground truth is established through laboratory testing (biocompatibility, absorbency) and clinical observation in the case of the in-use evaluation. No "experts" in the sense of human readers interpreting data are mentioned.

4. Adjudication method for the test set

Not applicable. The tests mentioned (biocompatibility, Syngyna absorbency, clinical in-use evaluation) are not subject to a human adjudication process in the way a diagnostic image interpretation would be.

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

No MRMC study was conducted or is applicable here. The device is a menstrual tampon, not an AI-assisted diagnostic tool.

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

Not applicable. The device is not an AI algorithm.

7. The type of ground truth used

Biocompatibility: Established through standardized in vitro and in vivo laboratory tests (cytotoxicity, systemic toxicity, irritation, sensitization, microbial, TSST-1).
Absorbency: Established through the "Syngyna Absorbency Results," which refers to a standardized laboratory test for tampon absorbency as per 21 C.F.R. § 801.430(e)(1).
Vaginal Micro Flora/Overall Safety: Established through a "double-blind, randomized, comparative in-use evaluation of tampon products." This would involve clinical observation and potentially laboratory analysis of vaginal microflora samples.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

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