(193 days)
o.b. Tampons are used to absorb menstrual fluid or other vaginal discharge.
o.b. ® Non-applicator Tampons are used to absorb menstrual fluid. The modified tampon will be available in the 15-18 gram syngyna absorbency range. o.b.® Non-applicator Tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
The provided text describes a 510(k) summary for a modified o.b.® Tampon. The objective of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria for a novel device. Therefore, the information provided does not align with the typical structure of reporting acceptance criteria and a study proving a device meets those criteria for a new or significantly modified medical device that requires clinical performance evaluation.
Specifically, the document focuses on substantial equivalence for the modified o.b.® Tampons. The "acceptance criteria" here are implicitly tied to demonstrating that the modified tampon is as safe and effective as the predicate device.
However, based on the provided text, I can extract the following information relevant to the intent of the questions, reinterpreting "acceptance criteria" as the characteristics that needed to be equivalent or demonstrated as safe.
Here's a breakdown of the available information in response to your questions:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics: Equivalent absorbency within a specific range, and similar materials, weight, and dimensions. | The only difference between the modified o.b.® tampons and the predicate tampons is that the absorbency has increased to 15-18 grams absorbency measured by the syngyna test method (21 CFR 801.430). This is accomplished by slight increases in the weight and dimensions of the tampons. |
The tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string, which are the same materials as the predicate.
(The specific absorbency range of the predicate is not explicitly stated, but the modified tampon falls within established regulatory ranges, and the submission argues this change does not alter substantial equivalence.) |
| Intended Use: Same as the predicate device. | The modified o.b.® Tampons are inserted into the vagina to collect menstrual fluid. This is the same intended use as current commercial tampons. |
| Biocompatibility: No adverse biological reactions. | Biocompatibility testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the modified o.b.® Tampon is equivalent to legally marketed tampons. This testing included Microbiological testing. |
| Safety (Clinical): No new or increased safety risks. | Clinical Testing has been conducted. Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for either biocompatibility or clinical testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document only mentions "preclinical and clinical testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the regulatory submission focuses on demonstrating substantial equivalence through specific tests (e.g., syngyna absorbency, biocompatibility, clinical safety comparable to existing products) rather than a diagnostic performance study requiring expert ground truth in the traditional sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided for this type of submission. Adjudication methods are typically used in studies where a new diagnostic or prognostic tool's output is compared against a consensus expert reading for 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:
- This information is not applicable/not provided. The device is a tampon, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/not provided. The device is a tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For absorbency, the ground truth is established by the syngyna test method (21 CFR 801.430), which is a standardized laboratory procedure.
- For biocompatibility, the ground truth would be established by standardized microbiological testing and potentially other biological assays, demonstrating no significant adverse reactions compared to established safety profiles.
- For clinical safety, the ground truth would be based on clinical observation and outcomes data from the "Clinical Testing" to show comparability to legally marketed tampons, likely looking for adverse event rates, irritation, or other safety endpoints. Specific methods are not detailed.
8. The sample size for the training set:
- This information is not applicable/not provided. There is no "training set" in the context of this device and its testing methodology.
9. How the ground truth for the training set was established:
- This information is not applicable/not provided.
§ 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).