(49 days)
Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.
Scented, deodorized menstrual tampons for the absorption of menstrual fluid.
This document is a 510(k) summary for a menstrual tampon, not a medical device that uses AI or complex algorithms. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not applicable. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through nonclinical testing, rather than performance against specific numerical acceptance criteria for diagnostic or algorithmic accuracy.
Here is an analysis based on the provided text, highlighting what is and isn't applicable:
Understanding the Device and Context:
The device is "Playtex Tampons" (specifically “Scented, Deodorized Menstrual Tampons”). This is a Class II medical device, but its evaluation is based on substantial equivalence to existing tampons, not on algorithmic performance or diagnostic accuracy. Therefore, many standard AI/ML device evaluation criteria do not apply.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a tampon and not an AI/ML diagnostic or assistive device, there are no specific numerical performance metrics like sensitivity, specificity, or accuracy that are typically used as acceptance criteria for AI devices. The "acceptance criteria" here are implicitly related to demonstrating safety and effectiveness comparable to predicate devices through nonclinical biological and chemical testing.
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Device Performance (Summary of Nonclinical Testing) |
|---|---|
| Safety and effectiveness (non-toxic, non-irritating, non-sensitizing, not promoting TSST-1 toxin production) equivalent to predicate tampons. | Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, and TSST-1 toxin testing were referenced. The submission states the device is "substantially equivalent to the predicate device in terms of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The provided document refers to "nonclinical testing" related to biological safety. The exact sample sizes for each type of nonclinical test (e.g., number of animals for toxicity, number of human subjects for sensitization) are not detailed in this 510(k) summary.
- Data Provenance: Not applicable for an AI/ML context. The testing is described as "nonclinical testing" which typically refers to laboratory or animal studies, and possibly human volunteer patch tests for sensitization, rather than clinical patient data. The country of origin for these nonclinical tests is not specified, but usually presumed to be where the manufacturer's testing facilities are located or contracted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. For biological safety testing of tampons, "ground truth" is established through standardized laboratory assays and protocols (e.g., toxicity assays, irritation studies), not through expert clinical consensus on images or diagnostic outcomes.
- Qualifications of Experts: Not applicable. The "experts" involved would be toxicologists, microbiologists, and other laboratory scientists conducting the nonclinical tests, but their role is not to establish "ground truth" in the diagnostic sense.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not the type of data or evaluation performed for a tampon's biological safety and substantial equivalence.
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:
- MRMC Study: No. This is not an AI/ML device; it's a tampon. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: For the purpose of establishing substantial equivalence for a tampon, the "ground truth" for safety and effectiveness is established through:
- Standardized Biological Assays: Measuring cytotoxicity, irritation, sensitization, and specific toxin production (TSST-1) against established safety thresholds and in comparison to predicate devices.
- Material Characterization: Ensuring the fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action as legally marketed predicate devices.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set for this type of device.
Conclusion Note:
This 510(k) document is a classic example of a "substantial equivalence" submission for a relatively low-risk medical device (Class II tampon). The evaluation focuses on demonstrating that the new device is as safe and effective as existing, legally marketed predicate devices, primarily through comparison of materials and nonclinical biological testing, rather than through complex clinical trials or performance assessments against AI-specific metrics.
§ 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).