(17 days)
Bard® PelviSoft™ Acellular Collagen BioMesh 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. It is specifically indicated for urethral procedures, vaginal prolapse and reconstruction of the pelvic floor.
Bard® PelviSoft™ Acellular Collagen BioMesh is a sterile, off-white, moist. tough but flexible fibrous mesh of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Bard® PelviSoft™ Acellular Collagen BioMesh is double vacuum-packed and heat sealed in peel-open aluminum foil (inner) and peel-open polyester/polvethylene (outer) pouches which are impermeable to oxygen and moisture.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) premarket notification for a medical device (Bard® PelviSoft™ Acellular Collagen BioMesh), demonstrating its substantial equivalence to predicate devices rather than presenting detailed performance study data.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document explicitly states:
- G. Performance Data Summary: "Bard® PelviSoft™ Acellular Collagen BioMesh is substantially equivalent to the predicate devices with regard to biocompatibility (Permacol®), materials (Permacol®) and product characterization (Permacol® and SurgiSIS™). The modified design does not raise any new safety or effectiveness issues."
This indicates that the device's approval is based on its substantial equivalence to already marketed devices, and no new performance study with specific acceptance criteria is detailed in this document.
§ 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.