(42 days)
First Quality Hygienic, Inc. Femtex and Private Label Scented plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance.
The provided document is a 510(k) premarket notification for Femtex and Private Label Scented Plastic Applicator Tampons. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for establishing acceptance criteria with a study comparing device performance against those criteria as would be done for novel devices or those undergoing a PMA.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the way a medical diagnostic or therapeutic device might. Instead, it focuses on demonstrating equivalence to an existing product through non-clinical testing.
Here's why the requested information cannot be fully provided from this document:
- Acceptance Criteria & Reported Performance: The document states "Assessment of Performance Standards: Not Applicable." This indicates that there are no specific, quantitative performance metrics with associated acceptance criteria like sensitivity, specificity, accuracy, etc., that are being measured and reported against. The focus is on demonstrating safety and general absorbency equivalence.
- Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These are all elements typically found in clinical studies or performance validation studies designed to quantify a device's effectiveness or accuracy in a diagnostic or therapeutic context. This 510(k) submission, for a tampon, relies on biocompatibility testing and absorbency testing to show equivalence to a predicate device.
However, I can extract the information that is present in the document related to testing, even if it doesn't fit the requested format exactly:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (Sensitization) | "The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." (Specific Pass/Fail criteria not detailed in this summary) |
| Biocompatibility (Vaginal Irritation) | "The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons." (Specific Pass/Fail criteria not detailed in this summary) |
| Absorbency (Standard Syngyna testing) | "Standard Syngyna testing confirmed the absorbency of these tampons." (Specific absorbency values / equivalency metrics not detailed in this summary) |
Note: The document explicitly states "Assessment of Performance Standards: Not Applicable" as the regulatory pathway is substantial equivalence based on predicate device and non-clinical testing, rather than meeting specific quantifiable performance standards like a diagnostic device. The performance is reported as "equivalent in terms of safety and effectiveness" for biocompatibility and "confirmed" for absorbency, without providing numerical acceptance criteria or results.
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 in the provided summary for any of the non-clinical tests (sensitization, vaginal irritation, Syngyna testing).
- Data Provenance: Not specified. These tests are typically laboratory-based non-clinical studies.
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 information is relevant for studies involving human interpretation (e.g., diagnostic imaging). The tests performed (biocompatibility, absorbency) are non-clinical laboratory tests, not requiring expert consensus on ground truth in the same manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information is relevant for studies involving human interpretation or clinical endpoints.
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 type of study is for diagnostic or AI-assisted devices for human interpretation and is not relevant for a tampon.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This type of study is for AI/algorithm-based devices and is not relevant for a tampon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility testing (sensitization, vaginal irritation): Ground truth/determination of safety and equivalence would be based on established toxicological principles and responses observed in standard biological models (e.g., in vitro, animal models).
- For absorbency testing (Standard Syngyna testing): Ground truth is based on the standardized measurement of fluid absorption under controlled laboratory conditions, as defined by the Syngyna method.
8. The sample size for the training set
- Not applicable. This concept pertains to machine learning models, which are not used here.
9. How the ground truth for the training set was established
- Not applicable. This concept pertains to machine learning models, which are not used here.
§ 884.5460 Scented or scented deodorized menstrual tampon.
(a)
Identification. A scented or scented deodorized 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. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).