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510(k) Data Aggregation
(23 days)
o.b.® Tampons are to be inserted into the vagina in order to absorb menstrual fluid.
The device is a cotton/rayon pledget with a removal string. It is available in various absorbencies.
Acceptance Criteria and Study for o.b.® Tampons:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The device performs equivalently to the predicate device of the same absorbency. |
| Syngyna Values (Absorbency) | Syngyna values were the same as the predicate device. |
| Toxicological Safety (No Untoward Results in Tests) | No untoward results were seen in the following tests on either the new material or the finished proposed device: - Cytotoxicity - Elution Method Cytotoxicity - Agarose Overlay Method Acute Systemic Toxicity in the Mouse - Mucosal (Vaginal) Irritation in the Rabbit - Dermal Irritation and Allergic Contact Sensitization: Human Repeat Insult Patch Test (RIPT) - Acute Intracutaneous Reactivity in the Rabbit - TSST-1, Tampon Sac Method |
| Clinical Safety (No Clinically Significant Differences vs. Commercially Available Tampon) | There were no clinically significant differences between the test (o.b.® Tampons) and control (commercially available tampon) products in a randomized, double-blind, two-way crossover study in healthy females over two menstrual cycles. Assessments included vaginal culture, speculum examinations (at screening, pre-, mid-, and post-menstrual visits), and vaginal and cervical colposcopy (at screening and post-menstruation). Subjects also completed a diary detailing tampon use. |
Study Information:
The provided document describes a modification to the o.b.® Tampons and aims to establish substantial equivalence to legally marketed o.b.® tampons. The study supporting this claim of substantial equivalence is outlined in the "Performance data" and "Clinical Equivalency" sections.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "healthy females" for the clinical equivalency study. However, the specific number of subjects in this study is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It does not explicitly state retrospective or prospective, but the description of a "randomized, double-blind, two-way crossover study" implies a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. The assessments mentioned (vaginal culture, speculum examinations, colposcopy) would typically be performed by medical professionals (e.g., gynecologists or trained clinicians), but their specific qualifications, number, or role in establishing ground truth (other than performing examinations) are not detailed.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the test set. It mentions assessments were performed, but not how disagreements or interpretations between multiple assessors (if any) were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
- Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding AI assistance is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?
- Not Applicable. This document describes the safety and effectiveness of a menstrual tampon, not an algorithm or AI device.
7. The Type of Ground Truth Used
- The ground truth for the clinical equivalency study appears to be established through a combination of:
- Clinical Assessments: Vaginal culture, speculum examinations, vaginal and cervical colposcopy performed by healthcare professionals.
- Subjective Reporting: Subject diaries detailing tampon use.
- Lab Tests: The "Performance Data" section also details various in-vitro and animal toxicology studies (e.g., cytotoxicity, irritation tests, TSST-1).
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there is no "training set." The studies described are for direct evaluation of the medical device itself.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See response to #8.
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