(67 days)
Femtex Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator
It appears that the provided text is a truncated 510(k) summary for a medical device called "Femtex Digital Tampons." This document type primarily focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on clinical performance against specific acceptance criteria for a diagnostic algorithm or device.
Therefore, the input does not contain the information necessary to answer the questions about:
- Acceptance criteria and reported device performance: This document explicitly states "Assessment of Performance Standards: Not Applicable" as it focuses on equivalence rather than meeting pre-defined performance thresholds for analytical or clinical performance (which are more common for diagnostic devices).
- Sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details. These are all concepts related to clinical studies for performance evaluation, which are not detailed in this 510(k) summary for a tampon. The "Non-Clinical Testing" section refers to biocompatibility and absorbency tests, not clinical performance for diagnostic accuracy.
In summary, the provided content is a 510(k) summary for a tampon, which focuses on material equivalence and non-clinical safety (biocompatibility, irritation, absorbency) rather than performance criteria and studies typically associated with "device meets acceptance criteria" in the context of diagnostic or interventional devices with quantifiable outcomes like sensitivity, specificity, or accuracy.
To answer your questions, I would need a different type of document, such as a clinical study report or a 510(k) summary for a diagnostic device that includes performance data.
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FIRST QUALITY HYGIEN CLINTON COUNTY INDUSTRIAL F P.O. BOX 330/NORTH ROAD/MCELHATTAN. PA 177
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510K SUMMARY
Device Name: Femtex Digital Tampons
Legally marketed device: Femtex Digital Tampons are substantially equivalent to legally marketed Femtex tampons with applicators.
Device description: Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus.
Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator
The material used in Femtex Digital tampons are comparable to those used in other legally marketed tampons.
Intended Use: Femtex Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Assessment of Performance Standards: Not Applicable
Non-Clinical Testing: Biocompatability testing of the Femtex Digital Tampons was carried out. The results of these tests demonstrate that Femtex Digital Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of Femtex Digital Tampons. In addition to the review of existing toxicological data in the public literature, the following tests were conducted relevant to the safety of Femtex Digital tampons.
- � irritation testing
- 0 sensitization testing
- 0 cytotoxicity testing
- vaginal irritation testing 0
§ 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).