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510(k) Data Aggregation
(22 days)
TOSAMA D.D.
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.
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(175 days)
TOSAMA D.D.
The MAXIM 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 tampon correctly into . the vagina (only the MAXIM Plastic Applicator Tampon).
The Maxim tampons are used to absorb menstrual fluid.
The Maxim series tampons comes with plastic applicator and without in
sizes: Regular, Super, Super plus, Ultra.
The Maxim tampons are made of commercial cotton and rayon, a
polyethylene/polyester cover, and cotton or rayon string.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is explicitly stated or can be reasonably inferred.
Note: This document is a 510(k) Summary of Safety and Effectiveness for a menstrual tampon. As such, the "device performance" and "acceptance criteria" presented here refer to the performance characteristics required for regulatory equivalence rather than a clinical efficacy study typically associated with AI/software devices. The questions in the prompt, especially those regarding AI, experts, and ground truth, are geared towards AI/ML devices. Therefore, many categories will indicate "Not Applicable" or "Not Provided" as this document does not pertain to an AI/ML device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Absorbency characteristics not significantly different from predicate devices such that safety is compromised. Specifically, the syngyna test method (21 CFR 801.430) is used to quantify absorbency, and any changes must not introduce new safety concerns or alter the intended function beyond acceptable limits for a menstrual tampon. The general safety and efficacy of menstrual tampons, including material composition and design, are implicitly assumed to be similar to legally marketed predicate devices. | The absorbency has increased to 15-18 grams, as measured by the syngyna test method (21 CFR 801.430). This increase was accomplished by slight increases in the weight and dimensions of the tampons. This change is considered within an acceptable range as the device is deemed "substantially equivalent" to predicate devices, implying that this altered absorbency does not introduce new safety or effectiveness concerns. |
| Biocompatibility | Materials must be biocompatible and not elicit adverse biological reactions when in contact with human tissue (intravaginal use). This is typically demonstrated through a series of ISO 10993 compliant tests (e.g., cytotoxicity, sensitization, irritation) and/or comparison to predicate devices with a known history of safe use. Microbiological testing must also demonstrate that the materials and finished product do not pose an undue risk of infection. | Biocompatibility and microbiological testing have been conducted on tampons made with these commercial materials. The results of these tests demonstrate that the Maxim tampons are equivalent to legally marketed tampons. The specific tests mentioned included "Microbiological testing" and "Clinical Testing," suggesting a comprehensive evaluation against established safety standards for similar devices. |
| Intended Use | The device must be suitable for its intended use of intravaginal absorption of menstrual or other vaginal discharge without presenting new or increased risks compared to predicate devices. For applicator versions, the applicator must facilitate correct and safe placement. | The intended use is clearly stated as "intravaginal absorption of menstrual or other vaginal discharge." For the plastic applicator version, its function is "for easing the placement of the tampon correctly into the vagina." This aligns directly with the established intended use of predicate menstrual tampons and is deemed acceptable. |
| Safety and Effectiveness (Overall) | The device must be as safe and effective as legally marketed predicate devices. This is the overarching criterion for substantial equivalence. Any modifications should not raise new questions of safety or effectiveness. | "Results of preclinical and clinical testing indicate that the safety of the modified tampon is comparable to current legally marketed, commercial tampons." This statement summarizes the overall finding of substantial equivalence, indicating that all relevant criteria were met. |
Study Details (Most are Not Applicable for this type of submission)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for biocompatibility, microbiological, or clinical testing. Details regarding the number of tampons tested in the syngyna absorbency test are also not provided in this summary.
- Data Provenance: The manufacturer is Tosama d.d., located in Slovenia. The specific country of origin for the data (e.g., where clinical testing was performed) is not provided. The terms "retrospective or prospective" are not applicable given the nature of the tests (biocompatibility, product performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a medical device 510(k) submission for a tampon, not an AI/ML diagnostic or prognostic device that relies on expert interpretation for ground truth. The evaluation involves standardized physical and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not a study requiring human adjudication of results in the traditional sense of clinical imaging or AI performance. The tests are objective (e.g., syngyna absorbency, microbiological assays).
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 not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Absorbency: The "ground truth" is established by the standardized syngyna test method (21 CFR 801.430), which is a reproducible laboratory measurement of fluid retention capacity.
- For Biocompatibility/Microbiological: The "ground truth" is defined by the passing criteria of accepted international standards (e.g., ISO for biocompatibility) and regulatory guidelines for microbiological safety. Pathological or outcomes data would relate to clinical trials, which are referenced as "Clinical Testing" but no specifics provided. Ultimately, the "ground truth" for showing equivalence rests on meeting established safety profiles of predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or associated ground truth.
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