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First Quality Hygienic slender regular and Junior 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

Femtex Junior and Slender Regular Tampons are menstrual tampons used to absorb menstrual fluid. These Femtex Open-End Tampons will be provided with 2 absorbencies: Slender Regular and Junior.

Femtex Open-End Junior and Slender Regular Tampons are made from rayon absorbent, cotton cord and cotton sewing thread.

The material used in Femtex Open-End Junior and Slender Regular Tampons are similar to those used in other legally marketed tampons.

The provided text is for a 510(k) premarket notification for Femtex Open-End Tampons. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way medical AI/imaging devices typically do.

Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in this context.

Here's why and what information can be extracted:

• Type of Device: Menstrual Tampons. These are Class II medical devices, and their regulatory pathway (510(k)) primarily requires demonstrating substantial equivalence, especially in terms of materials, absorbency, and safety (biocompatibility), rather than demonstrating diagnostic accuracy or efficacy through clinical studies with complex statistical endpoints.
• Performance Standards: The document explicitly states "Assessment of Performance Standards: Not Applicable" under "Non-Clinical Testing."
• "Study" Conducted: The non-clinical testing performed involves biocompatibility testing and Syngyna testing for absorbency. These are standard tests for tampons to ensure safety and function, but they don't generate the kind of data typically requested for AI device studies.

Information that can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria/Standards: The criteria are implicitly tied to the performance of the legally marketed predicate device and general safety standards for similar devices. Specifically mentioned are:
     • Biocompatibility (irritation, oral toxicity, cytotoxicity).
     • Absorbency (confirmed by Standard Syngyna testing).
   • Reported Device Performance:
     • Biocompatibility testing "demonstrate that the Femtex Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons."
     • Standard Syngyna testing "confirmed the absorbency of the Femtex Tampons."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. The document mentions "review of existing toxicological data in the public literature" and "tests have been conducted on components relevant to the safety of Femtex tampons." The sample sizes for these specific component tests are not detailed.
   • Provenance is not mentioned for the testing itself.

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. The "ground truth" for tampon performance is established by standardized physical/chemical tests (e.g., Syngyna for absorbency, lab tests for cytotoxicity), not expert clinical review in the sense of diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable.

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 an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For biocompatibility: Laboratory assays for irritation, oral toxicity, and cytotoxicity, likely compared against established safety thresholds.
   • For absorbency: Results from the "Standard Syngyna testing," which is a standardized laboratory method for measuring menstrual tampon absorbency.

8. The sample size for the training set:

   • Not applicable. This is not an AI device, so there is no concept of a "training set" in this context.

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

   • Not applicable.

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