(151 days)
SURGIS Staple Line Reinforcement II 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 non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.
SURGIS® Staple Line Reinforcement II is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in strip sizes (unfolded) of 1.0 x 10.8 cm to 1.2 x 19.8 cm. The device is surface treated to allow it to temporarily adhere to the stapler arms, is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
The provided text describes the 510(k) Premarket Notification for the SURGISIS® Staple Line Reinforcement II device. It includes information about the device's intended use, predicate devices, and a summary of testing for substantial equivalence. However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states "Outcomes show the device to be biocompatible, manufacturing processes to adequately disinfect the material, and mechanical characteristics to be sufficient." This is a general statement, not a table of specific acceptance criteria (e.g., tensile strength > X MPa, burst pressure > Y mmHg) and the corresponding numerical results obtained from testing.
- Sample Size (Test Set), Data Provenance: This information is not present. The document mentions "extensive biocompatibility testing, viral inactivation testing, and mechanical testing," but does not detail the sample sizes for these tests or the origin of any data (human or animal, retrospective/prospective).
- Number of Experts, Qualifications, Adjudication Method: These points are relevant to studies involving human interpretation or consensus, which are not described here. The tests mentioned are laboratory-based (biocompatibility, viral inactivation, mechanical), not studies requiring human expert adjudication.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study would compare human performance with and without AI assistance. The SURGISIS® Staple Line Reinforcement II is a physical medical device (surgical mesh), not an AI algorithm. Therefore, an MRMC study is not applicable.
- Standalone (Algorithm Only) Performance: As above, this device is a physical product, not an algorithm.
- Type of Ground Truth Used: For physical device testing, "ground truth" typically refers to established standards and methods for measuring material properties. The document doesn't specify these, beyond general statements about "biocompatibility testing," "viral inactivation testing," and "mechanical testing." It doesn't mention expert consensus, pathology, or outcomes data in the context of establishing a benchmark for performance.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: These points are relevant to machine learning or AI development, which is not applicable to this physical device.
In summary, the provided text describes a 510(k) submission for a physical surgical mesh. The "studies" mentioned are laboratory tests designed to demonstrate that the device is substantially equivalent to predicate devices based on its material properties and safety. It does not involve AI, human expert review, or clinical trials in the way your questions imply.
Therefore, I cannot populate the table and answer the specific questions based only on the provided text. The document is a regulatory summary focusing on substantial equivalence, not a detailed scientific study report with specific performance metrics against defined acceptance criteria.
§ 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.