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510(k) Data Aggregation
(30 days)
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
Playtex scented (or scented deodorized) and 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) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).
The provided text is related to a 510(k) submission for menstrual tampons, specifically regarding a change in the applicator color. It is not an AI/ML device, and therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.
However, I can extract the relevant "acceptance criteria" and the "study" that proves the device meets them from the document in the context of this specific regulatory submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit from Submission Goal) | Reported Device Performance/Conclusion |
|---|---|
| Safety: No adverse impact on safety due to applicator color change. | Risk Assessment & Leaching Studies: "As confirmed by our risk assessment and leaching studies, the proposed modification on the applicator colorant has no impact on the safety... of the device." (Conclusion) Additionally, "Biocompatibility Tests: Deemed not applicable for the modified device based on the results of the Leaching Studies. Biocompatibility testing was performed on the predicate device to confirm the tampon material safety." |
| Efficacy: No adverse impact on efficacy (absorbency) due to applicator color change. | Syngyna Testing: "No changes were made to the tampon pledget. Syngyna testing was performed and the results confirmed that the absorbance ranges are the same as the predicate device and comply with 21 CFR §801.430(f)(2)." (Performance Testing) "As confirmed by our risk assessment... the proposed modification on the applicator colorant has no impact on the... efficacy of the device." (Conclusion) |
| Substantial Equivalence: Device remains substantially equivalent to the predicate device. | Conclusion: "The proposed device is substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a regulatory submission for a physical medical device (menstrual tampon) with a minor change (applicator color), not an AI/ML device relying on test sets of data. The "tests" mentioned are laboratory tests (Leaching Studies, Syngyna testing) performed on the device itself or its materials, not on a data set.
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)
This information is not applicable. Ground truth, in the context of expert consensus, is relevant for AI/ML diagnostic or measurement devices. For this physical device, "ground truth" refers to established scientific/regulatory standards for material safety and absorbency, measured through laboratory methods, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical trials or studies for AI/ML devices or human reader performance. The studies performed here are laboratory tests.
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 information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a menstrual tampon.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. There is no algorithm involved in the performance or evaluation of this menstrual tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on established regulatory standards and scientific methodologies for biocompatibility (evaluated through leaching studies, indirectly confirming safety) and absorbency (Syngyna testing against 21 CFR §801.430(f)(2)). It's not based on expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML devices.
8. The sample size for the training set
This information is not applicable. There is no AI/ML algorithm requiring a training set for this device.
9. How the ground truth for the training set was established
This information is not applicable. Since there is no training set, there's no ground truth to establish for it.
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