(167 days)
The Hope&Her Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
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I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document appears to be an FDA 510(k) clearance letter for a medical device called "Hope&Her Vaginal Dilator (Various)".
The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as general controls, additional controls for Class II/III devices, Quality System regulations, and reporting requirements. It also includes the official Indications for Use statement for the device.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the number/qualifications of experts.
- Information on adjudication methods, MRMC studies, or standalone algorithm performance.
- The type of ground truth used or details about training set size and ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 884.3900 Vaginal stent.
(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).