(60 days)
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
o.b. ® tampons are used to absorb menstrual fluid or other vaginal discharge. These tampons will be available in regular, super and super plus absorbencies, and in applicator and non-applicator versions. o.b. ® non-applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. o.b. ® applicator tampons are made of cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string. The applicator consists of a cardboard laminate with a coating.
The provided text describes the 510(k) submission for o.b.® applicator and non-applicator tampons. This submission concerns a medical device rather than a software or AI-powered solution, so the typical structure for AI/software acceptance criteria and study details (like sample size for test/training sets, expert adjudication, MRMC studies, standalone performance) does not directly apply.
However, I can extract the relevant "acceptance criteria" (performance aspects tested) and the "study" conducted to demonstrate equivalence for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Aspect) | Reported Device Performance (Study Results) |
|---|---|
| Biocompatibility | - Cytotoxicity: Conducted on rayon and extracts thereof. |
- Vaginal Irritation: Conducted in Rabbits on rayon and extracts thereof.
- Acute Systemic Toxicity: Conducted on rayon and extracts thereof.
- Intracutaneous Toxicity: Conducted on rayon and extracts thereof. |
| Dermal Irritation/Sensitization | - Repeat Insult Patch Test: Confirmed lack of potential for human dermal irritation and sensitization. |
| Microbiological Safety | - Microbiological Testing: Conducted on rayon and extracts thereof. |
| Overall Safety Comparison | - Conclusion: Non-clinical and clinical testing results indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons. |
Explanation of Applicability:
For this device (tampons), the "acceptance criteria" are related to its biological and physical safety, as assessed through specific non-clinical (and implicitly "clinical" in the sense of human patch testing) tests. The "reported device performance" is the outcome of these tests, demonstrating that the device meets these safety standards and is comparable to previously marketed devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Non-clinical): Not explicitly stated with numerical values. For animal studies (Vaginal Irritation in Rabbits), a typical sample size for such tests involves a small group of animals (e.g., 3-6 rabbits per test group), but the exact number is not provided in the document.
- Sample Size (Clinical/Human Patch Test): "A Repeat Insult Patch Test" typically involves a moderate number of human subjects (e.g., 50-200) for dermal sensitization testing. The exact number is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the submission is to the U.S. FDA, implying that the studies would adhere to U.S. regulatory standards. These are considered prospective tests conducted specifically to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts
This section is not applicable in the context of this device and study. The "ground truth" for tampon safety is established through standardized laboratory and animal testing protocols, and sometimes human patch tests, which rely on objective measurements and established scientific methods rather than expert consensus on interpretive data (like in imaging or diagnostics).
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic or imaging studies. The safety tests performed for tampons are objective and do not involve such interpretive adjudication.
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
This is not applicable. MRMC studies are specific to evaluating the impact of an assistance (like AI) on human performance in diagnostic tasks. This submission is for a physical medical device (tampon) and does not involve AI or human "readers" interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This question is relevant to AI/software performance. The device is a tampon, which operates "standalone" in the sense that it performs its physical function without a human-in-the-loop interaction in the way AI algorithms do.
7. The Type of Ground Truth Used
The "ground truth" used for non-clinical testing (biocompatibility, toxicity) is based on:
- Standardized laboratory assays: Measuring specific biological responses (e.g., cell viability for cytotoxicity).
- Animal models: Observing physiological reactions in rabbits for irritation.
- Human volunteers: Observing dermal reactions in the Repeat Insult Patch Test.
Essentially, the ground truth is derived from objective biological and toxicological endpoints as defined by established scientific and regulatory testing guidelines.
8. The Sample Size for the Training Set
This is not applicable. "Training set" refers to data used to train machine learning models. This submission is for a physical device, not an AI or software product.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
§ 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).