(90 days)
Unscented menstrual tampons for the absorption of menstrual fluid.
Unscented menstrual tampons for the absorption of menstrual fluid.
The provided text is a 510(k) summary for Playtex Tampons, asserting their substantial equivalence to previously cleared Playtex tampons. It does not describe a study involving device performance metrics, acceptance criteria, or a test set as would typically be found for a medical device or AI/software product requiring quantitative performance evaluation.
Instead, the submission focuses on demonstrating that the new Playtex tampons have the same technological characteristics and mode of action as the predicate devices, and that nonclinical testing confirms their safety and effectiveness are substantially equivalent.
Therefore, most of the requested information about acceptance criteria, performance, sample sizes, experts, and adjudication methods is not applicable to this type of submission.
Here's a breakdown based on the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to legally marketed predicate devices. This means the new device must be as safe and effective as the predicate device(s). Specific quantitative performance metrics are not provided here for "device performance."
- Reported Device Performance: The submission states: "Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness."
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | As safe as predicate device(s) | Substantially equivalent |
| Effectiveness | As effective as predicate device(s) | Substantially equivalent |
| Technological Characteristics | Same or equivalent to predicate device(s) | Same or same mode of action |
| Materials | Same or equivalent to predicate device(s) | Same or same mode of action |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This submission does not describe a "test set" in the context of device performance evaluation with a specific sample size. The substantial equivalence claim is based on nonclinical testing and comparison to predicate devices, not typically involving a test set of human subjects or data for a new performance metric.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "test set" or explicit "ground truth" establishment by external experts described in this submission. The "ground truth" for substantial equivalence is based on regulatory standards and documented safety/effectiveness of predicate devices and nonclinical testing results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/software device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Ground Truth for Substantial Equivalence: The ground truth for this submission is the established safety and effectiveness of the predicate device(s) as determined by prior regulatory clearances and the results of nonclinical testing conforming to recognized standards (e.g., human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, Dioxin analysis and TSST-1 toxin testing).
8. The sample size for the training set
- Not Applicable. This is not an AI/software device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/software device.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).