(203 days)
The DePuy Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.
The Restore Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa, (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material approved K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.
The document is a 510(k) summary for a surgical mesh device, focusing on its substantial equivalence to previously marketed devices. It describes the device, its intended use, and the basis for substantial equivalence but does not include any performance studies or validation data against specific acceptance criteria.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.