(50 days)
Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.
Scented, deodorized menstrual tampons for the absorption of menstrual fluid.
The provided text is a 510(k) Summary for Playtex Tampons, specifically a submission for new scented, deodorized menstrual tampons. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it describes a regulatory submission focused on product characteristics and non-clinical testing for equivalence.
Here's a breakdown of the information that can be extracted, and an explanation for why other information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or detailed reported device performance data in a structured table. Instead, it relies on demonstrating substantial equivalence to already cleared devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in document) |
|---|---|
| Substantial equivalence to predicate devices (safety & effectiveness) | "The new Playtex tampons are substantially equivalent to the following tampons that have been previously cleared... The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginal wall are the same or have the same mode of action." |
| No significant difference in non-clinical safety aspects | "Nonclinical testing referenced for the determination of substantial equivalence includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing." (Results are summarized as meeting equivalence, not detailed) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical testing and equivalence to existing products, not a study involving a "test set" in the context of an AI or diagnostic device. Therefore, sample sizes for a test set and data provenance (country, retrospective/prospective) are not applicable and not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a 510(k) submission for tampons focused on equivalence and non-clinical safety, there is no mention of experts establishing ground truth for a test set. This type of analysis is typically for diagnostic devices or AI algorithms.
4. Adjudication Method for the Test Set
As there is no "test set" in the context of data for an algorithm or diagnostic device, adjudication methods are not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
An MRMC study is relevant for diagnostic devices where human readers interpret cases, often with and without AI assistance. This document describes a medical device (tampons) that does not involve human interpretation in this manner. Therefore, an MRMC study was not done and effect size is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This document pertains to a physical medical device (tampons) and not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is typically associated with diagnostic or AI device evaluations. For this device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Established performance of predicate devices: The "ground truth" is that the predicate devices are already deemed safe and effective.
- Non-clinical testing outcomes: The results of the non-clinical tests (sensitization, irritation, toxicity, TSST-1) serve as the "truth" for safety aspects, demonstrating that the new device does not pose new or increased risks.
8. The Sample Size for the Training Set
There is no training set in the context of this 510(k) submission as it is for a physical medical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this information is not applicable.
In summary: The provided document is a regulatory submission for a physical medical product (tampons) seeking substantial equivalence to existing products. It details the product, its intended use, and indicates non-clinical testing was performed to support safety and equivalence. It does not contain the detailed study design, performance metrics, and data analysis typically found in documentation for diagnostic devices or AI-based solutions, which would address many of the questions posed.
§ 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).