(40 days)
First Quality Hygienic plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
First Ouality Hygienic Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in four absorbencies: junior regular, super and super plus. These Tampons are made from rayon and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.
Here's a summary of the acceptance criteria and study information for the "Femtex" Tampons, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For the "Femtex" Tampons, the key performance standard mentioned is absorbency, measured by the Syngyna methodology. The acceptance criteria are defined by absorbency ranges for each tampon type. The reported device performance aligns with these ranges.
| Absorbency Type | Acceptance Criteria (Syngyna methodology - grams) | Reported Device Performance (Syngyna methodology - grams) |
|---|---|---|
| Junior | Max: 6 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Regular | Min: 6, Max: 9 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Super | Min: 9, Max: 12 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
| Super Plus | Min: 12, Max: 15 | Implied to meet, as "Standard Syngyna testing confirmed the absorbency of these Tampons." |
(Note: While the document states "Standard Syngyna testing confirmed the absorbency of these Tampons," it doesn't explicitly list the exact absorbency values obtained for each specific absorbency type. It relies on the assertion that these values were confirmed to be within the defined ranges.)
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the Syngyna absorbency testing or the other non-clinical tests mentioned (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity).
The data provenance is implied to be historical testing and a review of existing toxicological data in the public literature. There is no mention of specific country of origin for the data or if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The Syngyna absorbency test is a standardized laboratory test, and the other tests are standardized non-clinical evaluations, not typically requiring "expert" establishment of ground truth in the way a clinical study might (e.g., diagnosing a disease from images).
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are laboratory and non-clinical evaluations, not interpretive assessments that would require human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool but a physical menstrual product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm study was not done. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for absorbency was established through standardized laboratory testing (Syngyna methodology), which provides objective, quantifiable data. For biocompatibility and safety, the ground truth was established through standardized non-clinical testing (irritation, sensitization, acute oral toxicity, eye irritation, cytotoxicity) and review of existing toxicological data in public literature.
There is no mention of expert consensus, pathology, or outcomes data being the primary ground truth for the performance of this specific device, as these are typically more relevant for diagnostic or clinical devices.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI model that requires a "training set." The testing described is for performance and safety evaluation, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this 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).