(174 days)
The Enhance CSA is Indicated for women with the following symptoms of Female Sexual Arousal Disorder (FSAD): difficulty with arousal (and lubrication), sexual desire and ability to achieve orgasm.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Enhance Suction Cup Clitoral Stimulation Aid." It primarily focuses on the regulatory approval process and does not contain information on the acceptance criteria, specific studies, sample sizes, or ground truth establishment typically found in a clinical study report or a more detailed technical submission.
Therefore, I am unable to fulfill your request for the detailed information regarding acceptance criteria and the study proving the device meets them based only on the provided text. The document confirms that the device was deemed substantially equivalent to a predicate device and could be marketed, but it does not describe the specific performance testing or clinical studies that would contain the requested criteria and results.
§ 884.5970 Clitoral engorgement device.
(a)
Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.(b)
Classification. Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”