(49 days)
unscented menstrual tampons used to absorb menstrual fluid.
TAMPAX Tampons, Plastic Applicator will be provided in three absorbencies, regular, super and super plus. TAMPAX Tampons, Plastic Applicator have a colored plastic applicator. TAMPAX Tampons, Plastic Applicator are made of rayon fibers and overwrap, a cotton withdrawal cord, and a colored plastic applicator.
This device is a medical device, but not one that typically utilizes the types of acceptance criteria and studies you've requested (e.g., related to algorithms, expert consensus, or specific performance metrics like sensitivity/specificity). The provided text is for a menstrual tampon, and the assessment is focused on safety and equivalence to a predicate device, particularly regarding the addition of a colored applicator.
Therefore, many of the requested fields are not applicable in the context of this 510(k) summary. I will fill in the relevant information and indicate "N/A" (Not Applicable) for those that don't fit this type of device submission.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Non-clinical: | |
| - Biocompatibility: No irritation from colorants/applicator. | - Irritation and sensitization testing conducted. |
| - Biocompatibility: No sensitization from colorants/applicator. | - Cytotoxicity testing conducted. |
| - Biocompatibility: No cytotoxicity from colorants/applicator. | - Extraction assay conducted. |
- "The results of these tests demonstrate that TAMPAX Tampons, Plastic Applicator are equivalent in terms of their safety and effectiveness to legally marketed tampons." |
| - Biocompatibility: No significant leaching of substances (extraction). | |
| Clinical: | |
| - Safety: No increased product-related irritation compared to control. | - Clinical study showed "no differences in product related irritation or comfort between TAMPAX Tampons, Plastic Applicator and the control product." |
| - Safety: No significant or unexpected adverse events. | - "No significant or unexpected adverse events were observed during the study." |
| - Effectiveness: Equivalent to predicate (implied by safety and "substantially equivalent" claims). | The study focused on safety, and the conclusion states "the addition of colorant to the Plastic Applicator does not alter the safety or effectiveness of the device and that TAMPAX Tampons, Plastic Applicator are as safe and as effective as predicate, legally marketed tampons." This implies equivalence in effectiveness as well, primarily by not diminishing the existing effectiveness of the tampon design due to the colorant. |
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Test Set): 57 women
- Data Provenance: Not explicitly stated (e.g., country of origin). It was a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth in this context is self-reported irritation/comfort by the study participants and observation of adverse events by clinical staff, rather than expert interpretation of data.
4. Adjudication method for the test set
- N/A. Not applicable for this type of self-reported outcome and safety observation study.
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
- No. This is not an AI/imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device.
7. The type of ground truth used
- Clinical Endpoints: Patient-reported comfort and irritation, observation of adverse events during clinical study.
- Bench/Lab Endpoints: Results from irritation, sensitization, cytotoxicity, and extraction assays for biocompatibility.
8. The sample size for the training set
- N/A. There is no "training set" in the context of this type of traditional device submission. The study itself is an evaluation of the finished product.
9. How the ground truth for the training set was established
- N/A. Not applicable.
§ 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).