(471 days)
The Rostam pH Tampon is a menstrual tampon for the absorption of menstrual fluid. The pH Tampon reduces the usual vaginal pH increase during menses.
The Rostam pH Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed at the first stage in two absorbencies: regular and super. The Tampons reduce the usual vaginal pH increase during menses. These Tampons are made from rayon and cotton cord. The materials used in these tampons are similar to those used in other legally marketed tampons in the US, with the exception of an additive that is designed to reduce the usual increase in vaginal pH during menstruation.
The provided text describes a 510(k) summary for the Rostam pH Tampons. It outlines the device description, intended use, and non-clinical/clinical testing. However, it does not provide the specific details required to complete your request for acceptance criteria and the study proving the device meets those criteria.
The document states: "These tests, together with clinical evaluations, demonstrated that the tampon with additive is appropriate for its intended use." This is a general statement of compliance, but it lacks the quantitative results or specific criteria usually found in a detailed study report.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states generally that "clinical evaluations, demonstrated that the tampon with additive is appropriate for its intended use" and that "The Tampons reduce the usual vaginal pH increase during menses." | Not specified in the document. No specific metrics or quantitative results are provided. The document states that the tampon "reduces the usual vaginal pH increase during menses." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. The document mentions "clinical evaluations" but does not detail the methodology.
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 is not applicable as the device is a menstrual tampon, not an AI-powered diagnostic tool requiring human readability studies. The document does not mention any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as the device is a menstrual tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The implicit "ground truth" relates to the tampon's ability to "reduce the usual vaginal pH increase during menses" and its safety profile (irritation, sensitization, TSS-1 testing). The exact methodology for establishing the reduction in pH is not detailed, nor is the specific "ground truth" definition for the clinical evaluations mentioned.
8. The sample size for the training set
- Not applicable/Not specified. The clinical evaluations mentioned are likely for verifying safety and performance, not for training a model.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
Summary of available information:
The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards for safety and general performance. It lists various preclinical toxicology tests and states that "clinical evaluations" were performed to show the device is appropriate for its intended use, specifically highlighting its ability to "reduce the usual vaginal pH increase during menses." However, it does not offer the granular detail of specific acceptance criteria, study sizes, methodologies, or quantitative performance metrics that would be found in a full study report or a more detailed section on clinical test results.
§ 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).