(263 days)
The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse.
The Reia pessary is a collapsible vaginal pessary for non-surgical treatment of pelvic organ prolapse. The Reia pessary is reusable by a single user and is intended for prescription home use following an in-office size fitting process performed by a healthcare professional using fitting pessaries.
The Reia pessary is placed in the vagina, similar to a tampon or diaphragm, and by supporting the vaginal wall, the pessary prevents the descending organs from dropping into the vaginal canal. Similar to currently available pessaries, the Reia pessary has been evaluated for continuous use; however, its collapsible design enables simpler insertion and removal.
The Reia pessary is made entirely of medical-grade silicone and is a single part. The geometry of the pessary and the flexible nature of the silicone allows the Reia pessary to collapse to facilitate easy, comfortable insertion and removal. In its supportive state, the Reia pessary is domed at the top with a stem at the bottom. The end of the stem has a large loop that allows the user to easily locate, grasp, and pull the pessary out for removal. The expandable and collapsible technology fits the user's anatomy during insertion, use, and removal.
The Reia pessary is designed for self-management and to be easily collapsed for insertion and removal by any user. To insert the pessary, a user (e.g., patient or practitioner) pinches the outside of the pessary to elongate it into a narrower shape, allowing for easier, more comfortable insertion. Once it is released in the vagina, the pessary naturally expands to return to its supportive state. To remove the user pulls on the loop to re-elongate the pessary allowing for easier, more comfortable removal.
The Reia pessary is manually cleaned with soap and water by the user in the home environment or a healthcare facility between periods of use. The Reia fitting pessaries are manually cleaned and sterilized at a healthcare facility between uses.
The provided text is a 510(k) summary for the Reia pessary. It describes the device, its intended use, comparison to a predicate device, and performance data from bench and clinical testing. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/ML device, nor does it detail a study proving an AI/ML device meets acceptance criteria. The Reia pessary is a physical medical device (a vaginal pessary), and the provided document is a regulatory submission for this physical device, not an AI/ML software.
Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance, as this document pertains to a physical medical device and not AI/ML software.
The document discusses "effectiveness" in the context of a clinical study for the physical pessary, using the Pelvic Floor Distress Inventory - 20 (PFDI-20) scores as a primary effectiveness endpoint, showing equivalence to existing pessaries. This is a measure of the physical device's clinical efficacy, not an AI/ML algorithm's performance.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).