(99 days)
The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The AMS Elevate Anterior and Apical Prolapse Repair System is a modification of the Perigee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh assembly and non-implantable surgical instruments that can be used as aids to place the mesh assembly in the pelvic floor. The mesh assembly is made from knitted polymeric mesh.
The provided document is a 510(k) summary statement for a surgical mesh device (AMS Elevate™ Anterior and Apical Prolapse Repair System with IntePro® Lite™). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, the information requested in the prompt, which is typically relevant to the evaluation of AI/software devices (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance), is not present in the provided text.
The document states:
"The components of the AMS Elevate Anterior and Apical Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device."
This indicates that the assessment was based on comparing the new device's physical and biological properties to an already approved device, rather than a clinical performance study with predefined statistical endpoints.
Therefore, I cannot populate the requested table or provide answers to the specific questions regarding acceptance criteria and study details for an AI/software device based on this document.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.