(386 days)
The FEMME Applicator Tampon is an unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the tampon correctly into the vagina.
The FEMME Applicator Tampon is an unscented, menstrual tampon. The tampon is comprised of an absorbent viscose pledget, an overwrap, a removal string, and an applicator. The applicator contains 3 parts: a barrel, grip, and plunger. The tampon was designed as a compact tampon with a mushroom-shaped tip. The pledget is of the traditional cylindrical bullet-like shape and is covered with a thin layer of overwrap. The applicator has a standard rounded and smooth tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit container for retail sale. There are 3 specifications of tampon with different absorbencies: Regular, Super and Super plus. Each absorbency specification has a different color removal string and applicator.
The provided text describes the FEMME Applicator Tampon and its substantial equivalence to a predicate device, focusing on non-clinical performance data and biocompatibility. However, it does not include information about a study involving AI, human readers, or the establishment of ground truth in the context of device performance in a clinical or diagnostic setting. Therefore, many of the requested categories for AI-related studies cannot be filled from the provided text.
Here's the information that can be extracted from the provided text regarding acceptance criteria and device performance:
Acceptance Criteria and Device Performance (FEMME Applicator Tampon)
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Standard / Protocol) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Applicator | In Vitro Cytotoxicity (ISO 10993-5: 2009) | Not explicitly stated as "passed" or "failed" for individual tests, but the conclusion states "The data support the conclusion that the FEMME Applicator Tampon... is substantially equivalent to the predicate device and is safe and effective for its Indications for Use," implying all biocompatibility tests were met. |
| Intracutaneous study (ISO 10993-10: 2010) | (See above) | |
| Guinea pig maximization sensitization study (ISO 10993-10: 2010) | (See above) | |
| Pledget | Cytotoxicity study (ISO 10993-5: 2009) | (See above) |
| Vaginal irritation study (ISO 10993-10: 2010) | (See above) | |
| Guinea pig maximization sensitization study (ISO 10993-10: 2010) | (See above) | |
| Systemic toxicity study (ISO 10993-11: 2017) | (See above) | |
| Microbiological | ||
| Bioburden | ISO 11737-1: 2006 | 5.6 CFU/tampon |
| Effect on vaginal microflora | USP 71 | Does not alter the growth of normal vaginal microflora |
| Effect on S. aureus growth | USP 71 | Does not enhance the growth of Staphylococcus aureus (S. aureus) compared to an S. aureus control |
| Effect on S. aureus TSST-1 production | No increase in TSST-1 production compared to an S. aureus control | Did not increase production of Toxic Shock Syndrome Toxin-1 (TSST-1) compared to an S. aureus control |
| Chemical Residue | ||
| PCDD/Fs residues | EPA 1613B:1997 | N.D. (not detectable) |
| Pesticide and Cl residue | EN 15662: 2008 | N.D. (not detectable) |
| Physical Performance | ||
| Absorbency | 21 CFR 801.430 Syngyna absorbency protocol (Regular: 6.0-9.0 g, Super: 9.0-12.0 g, Super Plus: 12.0-15.0 g) | The absorbency ranges for all specifications met the requirements of 21 CFR 801.430. Specific values for each type were: Regular: 6.0 - 9.0; Super: 9.0 - 12.0; Super plus: 12.0 - 15.0 grams. |
| Removal String Strength | AS/NZS 2869: 1998 (Minimum attachment strength: ≥ 22.4 Newtons (N); Average value for production lot: ≥ 28 N) | Each tampon tested for every absorbency level met the Standard's minimum attachment strength requirement of 22.4 Newtons (N). Each absorbency data set met an average value of ≥ 28 N. |
| Fiber Shedding | Internal protocols | Does not exhibit the potential to shed more than the predicate fiber. |
| Tampon Integrity | Internal protocols | Meets the visual and observational requirements set for an acceptable subject device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of tampons tested) for each specific test. It refers to "each tampon tested for every absorbency level" for the removal string strength and "the subject device" for other tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The applicant is Jiangsu Yoai Technology Co., Ltd. from China, suggesting the testing may have been conducted in China or by a contracted lab. The tests refer to international standards (ISO, USP, EPA, EN, AS/NZS) and FDA guidance, indicating adherence to globally recognized methodologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical product (tampon) and the studies conducted are non-clinical (biocompatibility, performance, chemical residue). The "ground truth" here is objective measurements against established physical, chemical, and biological standards, not expert consensus on interpretations of images or clinical diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is relevant for studies involving human interpretation or clinical outcomes, which is not the case for the non-clinical tests performed on the tampon.
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. There is no mention of AI or human readers in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no mention of an algorithm or AI in the context of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests described are typically:
- Biocompatibility: Established biological reactions and tissue compatibility as defined by ISO standards.
- Microbiological: Quantifiable measures of microbial growth or toxin production.
- Chemical Residue: Quantifiable measures of specific chemical compounds according to EPA and EN standards.
- Physical Performance: Objective physical measurements (e.g., mass absorbed in grams, force in Newtons), visual inspections, and comparisons to predicate device shedding.
These are objective, measurable outcomes, not subjective expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is a physical medical device, not an AI or algorithm.
9. How the ground truth for the training set was established
Not applicable. 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).