(125 days)
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is intended for single patient use only.
The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.
The provided text describes a 510(k) summary for a surgical mesh device, Fortiva™ porcine dermis / Tutoplast® porcine dermis, which focuses on establishing substantial equivalence to a predicate device (Strattice®). The document does not outline specific acceptance criteria in a quantitative sense (e.g., a target sensitivity or specificity for a diagnostic device) or provide a study that explicitly demonstrates the device "meets" such criteria for clinical performance.
Instead, the performance data presented is focused on demonstrating equivalence to a predicate device through various in vitro and in vivo tests related to biomechanical properties, manufacturing process safety, and biocompatibility.
Here's a breakdown based on the information provided, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria for clinical performance or any metrics like sensitivity, specificity, or AUC. Instead, it describes equivalence-based performance criteria:
| Characteristic | Acceptance Criteria (Implicit for Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Biomechanical Properties (in vitro) | Equivalent to predicate device (Strattice®) in unimplanted tensile maximum load, burst strength, and suture pullout strength. | "Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices." |
| Viral Inactivation (manufacturing process) | Demonstration of ability to inactivate model viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance). | "The results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance) when used to process porcine dermis for the proposed device." |
| Pyrogenicity | Non-pyrogenic (rabbit pyrogen test) and endotoxin level |
§ 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.