(69 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 Apical and Posterior System 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 assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from non-viable porcine dermis.
The provided text is a 510(k) summary statement for a surgical mesh device, the AMS Elevate™ Apical and Posterior Prolapse Repair System. It details the device's description, indications for use, and a summary of testing for biocompatibility and performance.
However, the text does not contain any information about:
- Specific acceptance criteria (e.g., quantifiable performance metrics like sensitivity, specificity, accuracy, or physical properties thresholds).
- A detailed study proving device meets acceptance criteria. It only states that components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device." This is a high-level statement, not a detailed study description.
- Sample sizes for test sets, training sets, or data provenance.
- Number of experts or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This document is a regulatory submission for a medical device (surgical mesh), not an AI or diagnostic device that would typically involve the kind of performance studies expected in your request. The "Summary of Testing" section indicates that the testing revolved around biocompatibility and meeting performance requirements for substantial equivalence to a predicate device, which is different from a clinical performance study with statistical metrics.
Therefore, I cannot populate the table or answer the specific questions based on the provided text, as the information is not present.
§ 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.