(142 days)
The FemmyCycle® is a receptacle placed in the vagina to collect blood and cellular debris that is exuded from the uterus via the cervix during menstruation.
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The provided text is a 510(k) premarket notification approval letter for the FemmyCycle® menstrual cup, not a study evaluating the performance of an AI-powered device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets those criteria for an AI device.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or ground truth for test or training sets.
- Details about experts, adjudication methods, or MRMC comparative effectiveness studies.
- Information about standalone algorithm performance.
The document is an FDA approval for a medical device (a menstrual cup) based on substantial equivalence to a predicate device, not on a detailed performance study with defined acceptance criteria in the context of an AI/software device.
§ 884.5400 Menstrual cup.
(a)
Identification. A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.