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PROCEED Surgical Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh deigned for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer.

This document is a 510(k) summary for the PROCEED Surgical Mesh, comparing it to a predicate device. It confirms substantial equivalence based on technological characteristics and intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document discusses:

• Submitter and contact information
• Trade Name, Common Name, Classification Name, and Product Code
• Predicate Device: PROCEED Trilaminate Surgical Mesh
• Device Description: A sterile, thin, flexible laminate mesh for hernia repair, comprised of oxidized regenerated cellulose (ORC) fabric and PROLENE* Soft Mesh, encapsulated by polydioxanone polymer. The polypropylene mesh side allows for tissue ingrowth, while the ORC side provides a bioresorbable layer to minimize tissue attachment.
• Intended Use: For the repair of hernias and other fascial deficiencies requiring reinforcing or bridging material.
• Technological Characteristics: Stated as "identical to the predicate device, PROCEED SURGICAL Mesh."
• Conclusions: "The descriptive information provided about PROCEED Surgical Mesh demonstrates substantial equivalence to the predicate device."
• FDA Clearance Letter: Confirming substantial equivalence.
• Indications for Use Statement: Reiterating the intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC studies, as none of this information is present in the provided text.

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