(22 days)
The MOXIE tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
• The plastic applicator is for easing the placement of the tam pon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).
The MOXIE tampons are used to absorb menstrual fluid.
The MOXIE series tampons come with a plastic applicator and without a plastic applicator in sizes: Regular, Super ,Super plus and Ultra.
The MOXIE tampons are made of commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string.
This document, K092054, is a 510(k) summary for MOXIE tampons. It asserts substantial equivalence to previously marketed tampons, specifically MAXIM tampons (K080775), and other commercial tampons like Tampax Compak and o.b. Non Applicator Tampons.
Based on the provided text, there is no AI device and therefore no study proving an AI device meets acceptance criteria. The document describes a medical device (tampons) and its substantial equivalence to other legally marketed predicate devices, not an AI system.
However, I can extract information related to the assessment of the MOXIE tampons, which can be presented in a format similar to what would be used for an AI device, if we interpret "acceptance criteria" as the criteria for establishing substantial equivalence for the tampons.
Here's an attempt to structure the available information, keeping in mind that this is not a study of an AI device, but rather a regulatory submission for a conventional medical device:
Acceptance Criteria and Device Performance for MOXIE Tampons
Given that this document describes a conventional medical device (tampons) and not an AI device, the "acceptance criteria" are related to establishing substantial equivalence to predicate devices under 510(k) regulations, rather than performance metrics for an AI algorithm. The "study" refers to the testing conducted to support this claim of equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Performance / Assessment |
|---|---|
| Technological Characteristics | "No differences between the technical characteristics of the MOXIE tampons and the predicate characteristic of the substantial equivalent devices MAXIM tampons under K080775." |
| Material Biocompatibility | "Biocompatibility and microbiological testing has been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the Moxie tampons are equivalent to legally marketed tampons." |
| Clinical Safety (Preclinical & Clinical Testing) | "Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons." |
| Intended Use | "The MOXIE unscented menstrual tampon is intended for intravaginal absorption of menstrual or other vaginal discharge. This is the same intended use as current commercial tampons." |
| Predicate Device Equivalence | "MOXIE Plastic Applicator tampons are substantially equivalent to current commercially marketed TAMPAX COMPAK... and the MOXIE Non Applicator Tampons are substantially equivalent to o.b. ® Non Applicator Tampons." (Also, identical to MAXIM tampons K080775). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific tests (e.g., how many tampons were tested for biocompatibility, or how many subjects were in clinical testing). The term "commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string" implies standard materials, and testing would have been conducted on these materials or the finished product.
- Data Provenance: The document states that testing was conducted on tampons made with "commercial materials." The manufacturer is "Tosama d.d., Slovenia." The provenance of the specific test data (e.g., country of origin, retrospective/prospective) and internal vs. external lab is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this 510(k) summary for a menstrual tampon. "Ground truth" usually refers to definitive classifications or diagnoses for AI/imaging studies. Here, the "truth" is established through standardized material testing, biocompatibility assays, and clinical safety assessments, whose "experts" would be scientists and clinicians in their respective fields, but no specific number or detailed qualifications are provided.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. The safety and effectiveness of tampons are assessed through laboratory and clinical testing, not interpretive adjudication.
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, as this is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI device.
7. The type of ground truth used
The "ground truth" for the claim of substantial equivalence for these tampons comes from:
- Material specifications and composition: "commercial cotton and rayon, a polyethylene/polyester cover, and cotton or rayon string."
- Biocompatibility testing results: Demonstrating equivalence to legally marketed tampons.
- Microbiological testing results: Affirming safety.
- Preclinical and Clinical testing results: Indicating comparable safety to legally marketed tampons.
- Predicate device characteristics: The established safety and performance profile of the MAXIM, Tampax Compak, and o.b. tampons serve as the comparative benchmark ("truth").
8. The sample size for the training set
Not applicable, as this is not an AI device, and therefore there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI device.
§ 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).