(27 days)
The TAMPAX® V Plastic Applicator Tampons, unscented, are intended to be inserted into the vagina to absorb menstrual fluid.
Unscented menstrual tampons for absorption of menstrual fluid. The tampon is a conventional design consisting of an absorbent pledget, an overwrap, a withdrawal cord and an applicator. The materials of construction are cotton, rayon, polypropylene and polyester. The device functions by absorbing menstrual fluid after being inserted into the vagina.
The provided text describes a 510(k) premarket notification for a medical device (TAMPAX® V Plastic Applicator Tampons, unscented) and not a study assessing an AI/ML powered device. As such, most of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size, etc.) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance based on the information provided regarding the nonclinical tests and consumer preference testing.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Nonclinical Safety | Syngyna | No change from predicate device; within acceptable limits. | Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device. |
| Expulsion Force | No change from predicate device; within acceptable limits. | Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device. | |
| Tampon Withdrawal Cord Anchor Strength | No change from predicate device; within acceptable limits. | Results show no change from the predicate device. Results are within acceptable limits and similar to the predicate device. | |
| S. aureus Growth and TSST-1 Production | No adverse impact of modifications; within acceptable limits. | No adverse impact of the modifications on S. aureus growth and TSST-1 toxin production. Results are within acceptable limits and similar to the predicate device. | |
| User Preference/Safety | Consumer Preference In-use (Comfort) | Tampon and applicator are comfortable to use (no specific quantitative criteria given, implied positive user experience). | Confirmed that the tampon and applicator are comfortable to use. |
| Consumer Preference In-use (Adverse Events) | No reports of adverse events. | There were no reports of adverse events. | |
| General Equivalence | Material Safety and Design | Established in predicate 510(k) K061486. | Established in 510(k) submission K061486. |
| Biocompatibility | Completed in previously cleared similar 510(k) devices. Relevant for each material. | Biocompatibility testing of each material in the tampon has been completed in previously cleared similar 510(k) devices. | |
| Fluid Handling Capabilities | Similar to predicate device. | The device is designed to acquire and hold menstrual fluids similar to the fluid handling capabilities of the predicate device. (This is a design statement, performance is implied to result in similarity as per other tests). |
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 explicitly stated for any of the nonclinical tests. For "Consumer Preference In-use Testing," the sample size is not provided, only the outcome.
- Data Provenance: Not explicitly stated. The studies were conducted by The Procter & Gamble Company. Given the typical regulatory context for US FDA submissions, these tests would likely have been conducted in a controlled laboratory setting (for nonclinical) and with a consumer panel (for in-use testing), presumably within the US or compliant with international standards, but no country of origin is specified. The studies appear to be prospective for the current device's evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical medical device, not an AI model requiring expert-established ground truth. The "ground truth" for the nonclinical tests is based on established scientific measurement standards for features like strength, fluid absorption, and microbial growth, and for in-use testing, it's based on user feedback.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI model ground truth.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation includes:
- Established scientific/engineering measurements: For nonclinical tests like Syngyna, expulsion force, and withdrawal cord strength, the "ground truth" is derived from standardized physical and chemical testing methods.
- Microbiological assays: For S. aureus growth and TSST-1 production, the "ground truth" comes from controlled laboratory experiments measuring bacterial growth and toxin levels.
- Consumer self-reporting/feedback: For consumer preference in-use testing, the "ground truth" is based on the subjective experiences and reports of the participants regarding comfort and adverse events.
8. The sample size for the training set
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved.
§ 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).