(294 days)
Mesofol® Surgical Sheet is indicated when temporary wound support is required to reinforce soft tissues where weakness exists, or in conjunction with hernia repair or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.
Mesofol® Surgical Sheet is an implantable, resorbable, polymeric surgical sheet manufactured by ITV Denkendork in Germany. Mesofol® Surgical Sheet is offered in various sizes 4cm x 4cm to 20cm x 25cm and is 40jum in thickness. Mesofol® Surgical Sheet can be cut into different sizes and shapes by the end user. The sheet can be fixed with degradable suture material in situations where the anatomical conditions of the wound area are not suited to adequately fix the sheet. Mesofol® Surgical Sheet is manufactured from a lactide-caprolactone copolymer. Mesofol® Surgical Sheet is chemically broken down by hydrolytic cleavage of the polymer, giving rise to three monomers: 6-hydroxycaproic acid, D-lactic acid, and Llactic acid. 6-Hydroxycaproic acid is broken down to acetyl-CoA units via ß-oxidation (fatty acid metabolism) for further dearadation via the Krebs cycle. L-Lactate is broken down in the Cori cycle (lactic acid cycle) to qlucose via pyruvate. These two monomers are thus degraded to products that are physiologically metabolized by the body.
The provided text does not contain information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the other specific questions laid out in the request regarding sample sizes, expert involvement, or ground truth.
The document is a 510(k) summary for the Mesofol® Surgical Sheet, focusing on establishing substantial equivalence to predicate devices based on device description, intended use, and non-clinical testing (biocompatibility). It explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, I cannot extract the requested information from the provided text.
§ 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.