(89 days)
o.b. ® Tampons are used to absorb menstrual fluid or other vaginal discharge.
o.b. ® non-applicator and applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in Regular, Super, and Super Plus syngyna absorbency ranges. o.b.® non-applicator and applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the modified o.b.® Tampons are primarily based on biocompatibility and user safety, demonstrating equivalence to legally marketed tampons. The performance is reported through the results of specific preclinical and clinical evaluations.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical |
| Acute Systemic Toxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Intracutaneous Toxicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Vaginal Irritation (Preclinical) | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Ames Mutagenicity | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Chromosome Aberration Assay | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Unscheduled DNA Synthesis | Modified tampons equivalent to legally marketed tampons. | Preclinical | |
| Microbiological Safety | Microbiological Evaluation | Modified tampons equivalent to legally marketed tampons. | Preclinical |
| Clinical Safety/User Experience | Human Sensitization | Safety comparable to legally marketed, commercial tampons. | Clinical |
| Vaginal Microflora Study | Safety comparable to legally marketed, commercial tampons. | Clinical | |
| Human Vaginal Irritation Study | Safety comparable to legally marketed, commercial tampons. | Clinical |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample sizes for the preclinical or clinical evaluations.
- Data Provenance: The document does not explicitly state the country of origin of the data. The studies are referred to as "Preclinical Evaluations" and "Clinical Evaluations," implying that they were conducted specifically for this submission. The nature of these tests (e.g., vaginal irritation, microflora studies) suggests they would be prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the studies (biocompatibility, clinical safety) suggests that the interpretation of results would have been performed by qualified professionals (e.g., toxicologists, microbiologists, clinicians), but specifics are not given.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or similar devices where different human readers interpret cases. Tampons are a medical device for menstrual fluid absorption, and their evaluation focuses on safety, performance, and biocompatibility, not interpretive tasks for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the device described. The device is a physical product (tampon), not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance is established through experimental data from preclinical and clinical studies, demonstrating the physical, chemical, and biological properties of the modified tampons. The ultimate ground truth essentially compared the modified tampon's characteristics to the known safe and effective profile of the predicate device and general medical standards for such products.
- For biocompatibility: Lab test results (e.g., cytotoxicity assays, genotoxicity assays, irritation studies).
- For clinical studies: Human physiological responses (e.g., absence of sensitization, maintained vaginal microflora, absence of irritation).
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
§ 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).