(247 days)
The SURGISIS® SLR™ Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.
The SURGIS & SLR™ Staple Line Reinforcement device is produced from porcine small intestinal submucosa (SIS") that has been disinfected and treated for surgical use. The modified device is coated with an adhesive that eliminates the need for the application of a hydrogel to affix the device to the stapler arms. The device is supplied on a foam applicator, suspended in a form-fitting tray, and packaged in a sealed foil pouch to maintain sterility.
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter and a 510(k) summary for a medical device (Modified SURGISIS® SLR™ Staple Line Reinforcement).
While it mentions "performance bench and biocompatibility testing" and "Discussion of Tests and Test Results", it does not provide the specific details of these tests, their acceptance criteria, the reported device performance, sample sizes, ground truth establishment, or any information related to human reader studies (MRMC, standalone algorithm performance).
The text focuses on establishing substantial equivalence to a predicate device, rather than detailing the specifics of the actual performance studies themselves.
§ 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.