(62 days)
TAMPAX® Tampons are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The absorbent pledget consists of a pad of cotton and/or rayon fibers overwrapped with a non-woven fabric. A cotton withdrawal cord is sewn to the pad, and the pad is compressed into a traditional bullet-shaped pledget. The formed pledget is inserted into a flushable paper applicator consisting of an inner pusher tube and an outer insertion tube with an open distal end. Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TAMPAX® Tampons (K061486), structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with syngyna absorbency requirements of 21 CFR §801.430 | The device complies with the syngyna absorbency requirements of 21 CFR §801.430. |
| Safety equivalent to predicate device | "The same materials are used in both the predicate device and this device. Therefore, the in vitro and biocompatibility testing performed on the predicate device apply to this device as well. The results of these safety tests support the conclusion that this device is safe for use." |
| Effectiveness equivalent to predicate device | "The device complies with the syngyna absorbency requirements of 21 CFR §801.430. Therefore, additional testing of these tampons is not necessary to establish their equivalence to the predicate device in terms of effectiveness." |
| Substantial equivalence to predicate device (K040999) in terms of safety and effectiveness | "The results of evaluations of this device (TAMPAX® Tampons) support the conclusions that it is safe for its intended use and that it is substantially equivalent to the cited predicate device with regards to safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a test set as it relies heavily on the equivalence to a predicate device. The primary "test" mentioned is compliance with a regulatory standard (syngyna absorbency), which is a laboratory test, not a clinical study with a human subject test set.
- Sample Size: Not applicable/not explicitly stated for a "test set" in the traditional sense of a clinical trial.
- Data Provenance: Not applicable as it's primarily a regulatory compliance statement and reliance on prior predicate device testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on regulatory standards and previous testing of a predicate device. There is no mention of a ground truth established by human experts for a specific test set within this document.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring expert adjudication is mentioned.
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 medical device submission for tampons, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (tampon), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating effectiveness and safety is primarily based on:
- Regulatory Standard Compliance: Specifically, 21 CFR §801.430 for syngyna absorbency. This is a defined, objective test.
- Equivalence to Predicate Device: The safety and effectiveness are established by demonstrating that the new device is "substantially equivalent" to an already approved predicate device (TAMPAX® Tampons, K040999) due to similar materials and intended use, with the only difference being applicator grip design. The ground truth for the predicate device would have been established through its own initial approval process.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned.
§ 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).