(28 days)
Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
The Opal by Femtex Pull & Snap Unscented Compact Applicator Tampon is an unscented, compact menstrual tampon. It is intended for over-the-counter use for women's personal hygiene with respect to intra-vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina. The tampon itself is made of a strip of viscose rayon fibers in which a cord is inserted. A thin strip of nonwoven fiber covers the tampon, and the tampon is pressed firmly together. The applicator tubes are made of polyethylene (PE) and Polypropylene (PP) and include a barrel and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper. The tampons are marketed in Regular, Super, and Super Plus absorbencies.
The provided document is a 510(k) premarket notification for a medical device: "Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Regular, Super, and Super Plus."
This document describes the regulatory approval process for a menstrual tampon, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific concepts like test sets, training sets, ground truth, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance are not applicable to this document.
However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Syngyna Absorbency | Absorbency range requirements defined by 21 CFR 801.430 for Regular, Super, and Super Plus. | It was confirmed that the Regular, Super, and Super Plus absorbencies met the absorbency range requirements defined by 21 CFR 801.430. Specific absorbency ranges: Regular (6.0 - 9.0 g), Super (9.0 - 12.0 g), Super Plus (12.0 - 15.0 g). The "Light" absorbency listed for the predicate device (≤ 6 g) is not applicable to the subject device, which specifies Regular, Super, and Super Plus. |
| Extractables Testing | No safety concerns based on extractables. | Extractables testing was performed on all applicator components per Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems. Results of Extraction testing did not raise safety concerns. |
| Withdrawal Cord Attachment Strength | Minimum attachment strength of 22.4 Newtons (N) per AS/NZS 2869:1998 for each tampon tested. Each production lot's average value must be ≥ 28 N. | Each tampon tested for every absorbency level met the Australian Standard AS/NZS 2869:1998, Tampons-Menstrual, minimum attachment strength requirement of 22.4 Newtons (N). Each absorbency data set met an average value of ≥ 28N, which is the Standard's requirement for each production lot. |
| Fiber Shedding | Not shedding more fiber than the predicate device. | Fiber shed testing for the subject device demonstrated that it does not exhibit the potential to shed more fiber than the predicate device. (Note: This is a comparative criterion, not an absolute threshold mentioned in this document.) |
Since this is a submission for a physical medical device (tampon), the following points are not relevant to the provided text and would be N/A (Not Applicable):
2. Sample size used for the test set and the data provenance: N/A (Not an AI/ML study)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/ML study)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (Not an AI/ML 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: N/A (Not an AI/ML study)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/ML study)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Not an AI/ML study; ground truth for physical device testing typically refers to reference standards or validated measurement methods, which are implicitly covered by the "Acceptance Criteria" column above).
8. The sample size for the training set: N/A (Not an AI/ML study)
9. How the ground truth for the training set was established: N/A (Not an AI/ML study)
§ 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).