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Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Absorbency Ranges:

Absorbs menstrual flow

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

The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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Unscented menstrual tampons for absorption of menstrual fluid.

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This document describes a 510(k) submission for Playtex Tampons (K980478), focusing on safety and effectiveness tests rather than AI/machine learning device performance. Therefore, many of the requested categories related to AI models, such as sample size for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Primary Dermal Irritation: Not specified, but "Rabbits" plural implies more than one.
  • Acute Oral Toxicity: Not specified, but "Rats" plural implies more than one.
  • Subacute Vaginal Irritation: Not specified, but "Rabbits" plural implies more than one.
  • Human Repeat Insult Patch Test: 200 persons.
• Data Provenance: Not specified, but assumed to be internal laboratory testing or contract research organization testing for the manufacturer (Playtex). Retrospective or prospective is not clearly stated but typical in vivo/in vitro testing for device clearance is prospective.

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

Not applicable. The "ground truth" for these types of tests (e.g., irritation, toxicity) is based on standard biological and chemical assays and established scientific protocols, not expert consensus interpreting results. The experts involved would be laboratory scientists and toxicologists.

4. Adjudication Method for the Test Set

Not applicable. Results are based on objective measurements and established protocols for biological and chemical assays.

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 not an AI/machine learning device.

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

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

7. The Type of Ground Truth Used

The ground truth is based on:

• In vitro/In vivo biological assays: For irritation, toxicity, and inhibition studies, ground truth is determined by the direct observed biological response or lack thereof according to established scientific methodologies and endpoints.
• Chemical analysis: For Dioxin analysis, ground truth is determined by chemical quantification against established limits.
• Toxin quantification: For TSST-1, ground truth is determined by laboratory methods to measure toxin levels.

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. This is not an AI/machine learning device.

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Unscented menstrual tampons for the absorption of menstrual fluid.

Unscented menstrual tampons for the absorption of menstrual fluid.

The provided text describes a 510(k) submission for Playtex Tampons, specifically addressing their substantial equivalence to previously cleared Playtex Gentle Glide Tampons. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document states:

• Device Name: Playtex Tampons (Unscented Menstrual Tampons)
• Predicate Device: Previously cleared Playtex Gentle Glide Tampons, Regular, Super and Super Plus.
• Intended Use: Unscented menstrual tampons for the absorption of menstrual fluid.
• Technological Characteristics: The new tampon has the same technological characteristics as the predicate device (fiber, string, materials in contact with the vaginal wall, and mode of action are the same).
• Nonclinical Testing: Dioxin analysis, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing.
• Conclusion: The Playtex Tampons are substantially equivalent to the predicate device in terms of safety and effectiveness based on the review of the data.

Therefore, I cannot populate the table or provide information for the specific points you requested, as the document focuses on demonstrating substantial equivalence rather than reporting on specific performance acceptance criteria from a study.

The document indicates that the determination of safety and effectiveness was based on the nonclinical testing mentioned above and a comparison to the predicate device. It does not describe a clinical study with a test set, ground truth, or statistical analysis of performance metrics against predefined acceptance criteria for the new device.

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