(268 days)
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
The Scented Tampons are:
- Scented Digital
- Scented Plastic Applicator (full size (long) and compact)
They are scented versions because of the presence of a fragrance.
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (
The provided document describes a 510(k) submission for "ONTEX SCENTED DIGITAL AND PLASTIC APPLICATOR TAMPONS". This is a medical device application for tampons, not a diagnostic or AI-driven device. Therefore, the typical acceptance criteria and study designs involving performance metrics like sensitivity, specificity, MRMC studies, and ground truth establishment, which are relevant to image analysis or diagnostic algorithms, are not applicable here.
Instead, the acceptance criteria for this type of device focus on biocompatibility and microbiology to ensure safety and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, while noting the different nature of this device:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated) | Device Performance (Reported) |
|---|---|---|
| Biocompatibility | Non-cytotoxic | Passed (non-cytotoxic) |
| Non-irritant | Passed (non-irritant), no terminal or gross observations in reproductive tracts of animals, no toxic signs, negligible dermal response. | |
| No potential for dermal irritation | Passed (no potential for dermal irritation) | |
| No potential for allergic contact sensitization | Passed (no potential for allergic contact sensitization) | |
| Microbiology | Does not enhance growth of Staphylococcus aureus | Passed (does not enhance growth of Staphylococcus aureus) |
| Does not increase production of Toxic Shock Syndrome Toxin-1 (TSST-1) | Passed (does not increase production of TSST-1) | |
| No effect on culture pH | Passed (no effect on culture pH) | |
| Does not alter growth of normal vaginal microflora | Passed (does not alter growth of normal vaginal microflora) | |
| Voluntary Standards Compliance | Complies with applicable voluntary standards for biocompatibility | Passed all testing in accordance with national and international standards. |
| Substantial Equivalence | Differences from predicate device do not raise concerns regarding safety and effectiveness | Demonstrated through biocompatibility and microbiological studies that the scented tampon is substantially equivalent in terms of biocompatibility, microbiological, and safety aspects. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for specific tests. The tests appear to be laboratory-based and conducted on the materials or final product. The provenance of the data is from ONTEX BVBA, Belgium, as stated in the submission sponsor information. The studies are non-clinical performance data, likely conducted prospectively as part of the device development and submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the non-clinical testing performed for this device. Ground truth, in the context of device performance, typically refers to expert consensus or pathology for diagnostic devices. For biocompatibility and microbiological testing, standardized laboratory protocols and expert analysis of results are followed, but "ground truth" as a consensus of clinical experts is not relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or for diagnostic evaluations where multiple human readers assess cases. The studies described are laboratory-based biocompatibility and microbiology tests, which follow standardized testing procedures rather than human expert adjudication of results from a "test set" in the clinical sense.
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. MRMC studies are specifically for evaluating diagnostic devices, often AI-powered, where human readers interact with or without AI assistance. This device is a tampon, not a diagnostic tool, and involves no AI component or human reader interpretation for its function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as there is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance tests for this device is based on standardized laboratory testing protocols and established scientific criteria for biocompatibility and microbiological safety. For example, for Staphylococcus aureus growth, the ground truth is "does not enhance growth," which is determined by comparing growth in the presence of the tampon to a control, according to established microbiological methods.
8. The sample size for the training set
This is not applicable, as there is no training set for an AI/algorithm-driven device.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/algorithm-driven device.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).