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510(k) Data Aggregation
(56 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dioxin Analysis | Not explicitly stated as "passing" or "failing"; implies compliance as part of the overall acceptance. |
| Primary Dermal Irritation (Rabbits) | Non-Irritating |
| Acute Oral Toxicity (Rats) | Non-Toxic |
| Subacute Vaginal Irritation (Rabbits) | Non-Irritating |
| Agar Diffusion Study | No zones of inhibition were detected |
| TSST-1, Toxin Testing | Results in the range of values of commercially sold tampons (previously conducted on the same rayon pledget submitted in K971174) |
| Human Repeat Insult Patch Test (200 persons) | Implies no significant safety issues, as it contributed to the overall substantial equivalence finding. |
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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