(25 days)
Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.
Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
This 510(k) submission (K070745) for the Playtex Gentle Glide Plastic and Multipack Tampons is for a medical device modification, not a novel AI/medical imaging device. Therefore, the questions related to AI performance, such as MRMC studies, standalone algorithm performance, and expert ground truth establishment for deep learning models, are not applicable here.
The "acceptance criteria" in this context refer to various safety and performance tests to ensure the modified tampons are substantially equivalent to previously cleared versions.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Cytotoxicity testing | Modified device meets all device input requirements. |
| Acute systemic toxicity testing | Modified device meets all device input requirements. |
| Vaginal irritation testing | Modified device meets all device input requirements. |
| Dermal irritation | Modified device meets all device input requirements. |
| Allergic contact sensitization tests | Modified device meets all device input requirements. |
| Microbial agar diffusion | Modified device meets all device input requirements. |
| Toxic shock syndrome toxin-1 (TSST-1) testing | Modified device meets all device input requirements. |
| Technological characteristics (fiber, string, materials) | Same as cleared tampon or same mode of action. |
| Shape of final formed pledget (for each absorbency) | Essentially identical to the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for each of the performance tests (e.g., cytotoxicity, irritation, TSST-1). These are laboratory-based tests on materials and devices, not studies involving human subjects in the sense of clinical trials for imaging. The data provenance is not explicitly stated in terms of country of origin, but it would be expected that these tests were conducted by Playtex Products, Inc. or their contracted laboratories, likely in the US given the submission to the FDA. These are prospective tests conducted on the modified device to demonstrate its safety and performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device modification submission. The "ground truth" for these performance tests is based on established scientific methodologies and standards for cytotoxicity, toxicity, irritation, and microbial testing, rather than expert consensus on diagnostic images. The performance is measured against established biological safety limits.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" usually refers to the process of resolving discrepancies among multiple human readers in an imaging study. For laboratory tests, results are typically determined by scientific protocols and analyses, not by adjudication among experts in that fashion.
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
Not applicable. This is a submission for a tampon modification, not an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a submission for a tampon modification, not an AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" here is based on the results of established biological safety and material compatibility tests against recognized standards and limits. For example, cytotoxicity testing would compare cell viability to a control, and irritation tests would assess tissue response against a baseline or a known irritant/non-irritant. The "ground truth" for the physical characteristics like pledget shape is visual or dimensional comparison to the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device modification. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).