(23 days)
Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.
Permacol® T-piece and Permacol® Rectocele-piece are substantially equivalent to the predicate devices because they have the same intended uses and very similar technological characteristics.
The provided text is a 510(k) summary for the Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria and a study proving a device meets those criteria, as typically found in comprehensive performance studies for AI/software devices.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document states that "Biocompatibility and bench studies have been completed and support the safety and effectiveness" but does not detail the acceptance criteria or specific performance results of these studies in a format that would allow for the requested table and study description. It also explicitly refers to these studies being incorporated by reference, meaning the details are not contained within this particular submission.
§ 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.