(84 days)
Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus. Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable. Except for the additive, the materials used in Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Tampax Tampons with Additive," structured according to your request.
It's important to note that the provided text describes a medical device (tampons) and not an AI/software device. Therefore, some of your requested categories (like "MRMC comparative effectiveness study," "standalone algorithm performance," "sample size for training set," and "ground truth for training set") are not applicable in this context and will be marked as such.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| - Biocompatibility (irritation, sensitization, cytotoxicity, genotoxicity) | "The results of these tests demonstrate that Tampons with Additive are equivalent in terms of safety...to legally marketed tampons." Specific tests conducted for irritation, sensitization, cytotoxicity, and genotoxicity. |
| - Microbiological safety (in vitro vaginal microflora, additional microbiological testing) | "The results of these tests demonstrate that Tampons with Additive are equivalent in terms of safety...to legally marketed tampons." Specific tests conducted for in vitro vaginal microflora and additional microbiological testing. |
| - No significant difference in product-related irritation during normal menstrual use compared to control. | "The study results showed no difference in product related irritation...between Tampax Tampons with Additive and the control product." |
| - No significant or unexpected adverse events | "No significant or unexpected adverse events were observed during the study." |
| Effectiveness: | |
| - Equivalent effectiveness to legally marketed tampons. | "The results of these tests demonstrate that Tampons with Additive are equivalent in terms of...effectiveness to legally marketed tampons." |
| - No difference in comfort compared to control. | "The study results showed no difference in...comfort...between Tampax Tampons with Additive and the control product." |
| - Performance as well as predicate, legally marketed tampons. | "Results of the non-clinical and clinical tests showed that the additive does not alter the safety or effectiveness of the device and that Tampax Tampons with Additive are as safe and as effective , and perform as well as predicate, legally marketed tampons." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the clinical study. The text mentions "A clinical study was done" and "The study compared Tampax Tampons with Additive to a control tampon," indicating a comparative study, but the specific number of participants is not provided.
- Data Provenance: Not specified (e.g., country of origin). The study was conducted as a "clinical study" to evaluate safety and compare it to predicates, implying a prospective design.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The "ground truth" for tampon safety and effectiveness is established through clinical observation, patient reported outcomes, and laboratory testing rather than expert-labeled image data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in image interpretation or diagnostic tasks. In this clinical study, safety endpoints would likely be assessed by investigators and reported (e.g., through adverse event reporting, physical examinations, and patient questionnaires).
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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 question is not applicable. This is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is not an algorithm-driven device. The "device performance" refers to the physical product itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical testing was established through laboratory testing (biocompatibility, microbiology).
- For the clinical testing, the "ground truth" for safety and effectiveness was established through clinical observation, patient feedback (comfort, irritation), and assessment of adverse events, which can be considered a form of outcomes data and clinical endpoints. The comparison was against a "control tampon."
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The sample size for the training set:
- This question is not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- This question is not applicable. There is no training set for this device.
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Appendix 8
510(k) Summarv
Device Name: Tampax Tampons with Additive
Legally marketed device: Tampons with Additive are substantially equivalent to legally marketed Tampax OEF tampons.
Device description: Tampons with Additive are menstrual tampons used to absorb menstrual fluid. Tampax Tampons with Additive will be provided in 4 absorbencies, junior, regular, super and super plus
Tampax Tampons with Additive are made of cotton and/or rayon fibers and overwrap, cotton cord, and an additive. The applicator used in Tampax tampons with Additive is flushable and biodegradable.
Except for the additive, the materials used in Tampons with Additive are identical to those used in other legally marketed Tampax tampons. This additive has been adequately characterized and evaluated using scientifically valid safety tests.
Intended Use; Tampax Tampons with Additive are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Assessment of performance data
Non-clinical testing: Biocompatibility and microbiological testing of the additive and Tampax Tampons with Additive was conducted. The results of these tests demonstrate that Tampons with Additive are equivalent in terms of safety and effectiveness to legally marketed tampons. In addition to the review of existing toxicological data, the following tests were conducted related to the safetv of Tampax Tampons with Additive:
- Irritation and sensitization testing .
- . Cytotoxicity testing
- . Genotoxicity testing
- In vitro vaginal microflora testing .
- . Additional microbiological testing
Clinical Testing: A clinical study was done to evaluate the safety of Tampax Tampons with Additive and to compare its safety to its predicates. The study compared Tampax Tampons with Additive to a control tampon during normal menstrual use. Safety was evaluated by comparing the prevalence of product related irritation and other parameters after normal menstrual use.
The study results showed no difference in product related irritation, comfort, or other parameters between Tampax Tampons with Additive and the control product. No significant or unexpected adverse events were observed during the study.
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Conclusions: Results of the non-clinical and clinical tests showed that the additive does not alter the safety or effectiveness of the device and that Tampax Tampons with Additive are as safe and as effective , and perform as well as predicate, legally marketed tampons. Further, the results demonstrated that Tampax Tampons with Additive are substantially equivalent to other legally marketed tampons.
§ 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).