(84 days)
GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture-line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.
The provided text is a 510(k) premarket notification for a medical device called GORE® ENFORM Biomaterial. It describes the device, its indications for use, and a summary of performance testing. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device.
The document states:
- "No animal studies were required to support this change."
- "No clinical data was required to support this change."
- "Simulated use testing conducted as part of design verification demonstrated the GORE® ENFORM Biomaterial devices can be introduced via minimally invasive surgical procedures when used according to the instructions for use of the device."
- "Other bench testing was leveraged from the predicate GORE® ENFORM Biomaterial device."
This 510(k) pertains to a surgical mesh/biomaterial, not an AI or algorithm-based device. Therefore, the questions related to AI/algorithm performance (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, ground truth types) are not applicable to the information contained in this document.
Therefore, I cannot provide the requested information based on the given text because the device described is not an AI/algorithm-driven medical device, and the document does not include the type of performance data relevant to AI/algorithm 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.