Search Results

First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator tampons are a menstrual tampon 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Femtex and Private Label Scented Plastic Applicator Tampons:

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance. As such, many of the typical clinical study elements you've requested (like sample sizes for test sets, expert ground truth, MRMC studies, etc.) are not applicable or not present in these types of submissions.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to show the device's safety and performance equivalence to existing tampons.

Acceptance Criteria and Reported Device Performance

Further Details on the "Study" (Non-Clinical Testing)

The document refers to non-clinical testing rather than a traditional clinical study.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified for any of the non-clinical tests. These tests typically use laboratory samples of materials or finished products, not human subjects.
   • Data Provenance: Not explicitly stated, but it would be laboratory testing data, presumably conducted in the United States or by a qualified lab following international standards. It is retrospective in the sense that the testing was performed on manufactured components/products, not on prospective human cohorts.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For non-clinical tests like biocompatibility and Syngyna absorbency, "ground truth" is established by standard laboratory protocols and measurements, not by expert consensus on individual cases. The interpretation of the results would be done by qualified toxicologists or laboratory personnel.

3. Adjudication method for the test set:

   • Not Applicable. This concept applies to human reader studies or clinical trials where discordant interpretations might need resolution. Non-clinical lab tests have defined pass/fail criteria.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This is a non-clinical device, not an imaging or diagnostic AI device.

5. 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.

6. The type of ground truth used:

   • Laboratory Standard Results/Measurements: For biocompatibility, the ground truth is established by the outcome of standard toxicology assays (e.g., cell viability in cytotoxicity, animal skin reactions in irritation/sensitization). For absorbency, it's the measured fluid uptake compared to established Syngyna test standards.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The non-clinical tests are performed on the device or its components directly.

8. How the ground truth for the training set was established:

   • Not Applicable. (As above, no training set).

In summary: The provided 510(k) summary focuses on demonstrating that Femtex and Private Label Scented Plastic Applicator Tampons are substantially equivalent to existing, legally marketed tampons based on standard non-clinical safety (biocompatibility) and performance (absorbency) testing. It explicitly states "Assessment of Performance Standards: Not Applicable" in the summary because it's a predicate-based submission, not a novel device requiring new performance standards to be met. The "study" here is rigorous laboratory testing to confirm material safety and functional absorbency according to established industry and regulatory norms, rather than a clinical trial with human subjects.

Ask a specific question about this device

Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made 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 with 4 absorbencies, Junior, 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 material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons.

The provided text is a 510(k) summary for "Femtex and Private label Scented Plastic Applicator Tampons." It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information, addressing the points requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Cytotoxicity testing: Results not detailed, but stated as "0 cytotoxicity testing" (implies none or no cytotoxicity found).
• Sensitization testing: Results not detailed, but stated as "0 sensitization testing" (implies none or no sensitization found).
• Vaginal irritation testing: Results not detailed, but stated as "0 vaginal irritation testing" (implies none or no vaginal irritation found). |
  | Absorbency | Standard Syngyna testing to confirm declared absorbencies (Junior, Regular, Super, Super Plus). | "Standard Syngyna testing confirmed the absorbency of these tampons." (Specific absorbency values for each size are not provided in this summary, but the general criteria of confirmation was met). |
  | Material Composition | Materials similar to legally marketed tampons. | "The material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons." (Material listed: rayon absorbent, cotton cord, cotton sewing thread, fragrance). |
  | Fragrance Safety | Biocompatibility tests imply safety of added fragrance. | Included in the "0 irritation testing," "0 cytotoxicity testing," "0 sensitization testing," and "0 vaginal irritation testing" for the overall tampon, which includes the fragrance. |

2. Sample Size Used for the Test Set and the Data Provenance

The 510(k) summary does not explicitly state the sample sizes for the non-clinical tests (irritation, cytotoxicity, sensitization, vaginal irritation, Syngyna absorbency). It refers to "tests have been conducted" but does not give numerical sample sizes for these tests.

The data provenance is retrospective, as the submission refers to the review of "existing toxicological data in the public literature" in addition to the new tests conducted. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document does not describe the use of human experts to establish "ground truth" in the way it would for a diagnostic device (e.g., expert radiological review). The tests performed (biocompatibility, Syngyna absorbency) are laboratory-based and rely on established scientific methods and instrumentation rather than expert interpretation of a 'test set' in the context of disease diagnosis. Therefore, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, the "test set" here refers to samples of the tampon material undergoing laboratory tests, not a set of cases requiring human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is a 510(k) premarket notification for a medical device (tampon), not a diagnostic algorithm. Therefore, an MRMC comparative effectiveness study, which is typically used for assessing reader performance with and without AI assistance in diagnostic imaging, was not performed and is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (tampon), not an algorithm or AI system. Its performance is intrinsic to the product itself, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific methods and accepted safety/performance profiles for tampons.

• Biocompatibility: Absence of irritation, cytotoxicity, or sensitization as determined by standardized laboratory assays. The "ground truth" is that the materials do not elicit adverse biological responses.
• Absorbency: The absorbency capacity as measured by the Syngyna test, which is a standardized method for determining tampon absorbency. The "ground truth" is the measured absorbency value, which is then compared against established ranges for stated absorbencies (Junior, Regular, Super, Super Plus).
• Material Equivalence: The composition of the materials used in the new device must be similar to those in legally marketed predicate devices. "Ground truth" here is the established safety and performance of existing, cleared tampon materials.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device like a tampon.

Ask a specific question about this device