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As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470) Rostam applicator tampons are made of cellulosic or synthetic material that is inserted ire the vagina and used to absorb menstrual or other discharge.

Rostam Interlude Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in three absorbencies: regular, super and super plus. These Tampons are made from rayon and cotton and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.

The provided text is a 510(k) summary for Rostam Interlude Plastic Applicator Tampons. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies.

The document indicates "Assessment of Performance Standards: Not Applicable" and states "Non-Clinical Testing: Biocompatibility testing and safety evaluations of tampon components were historically carried out. The results of these tests demonstrate that these Tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these Tampons."

This indicates that the device's performance was not evaluated against specific, new quantifiable acceptance criteria, but rather its equivalence to existing predicate devices was established based on historical testing and standard absorbency tests (Syngyna).

Therefore, as per the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details.

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