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The Biodesign® 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 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 Biodesign® Staple Line Reinforcement device is part of a family of implant devices manufactured from porcine small intestine that are disinfected and processed to remove the tunica mucosa from the inner intestinal surface and tunica muscularis from the outer intestinal surface. The resulting membrane is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Biodesign® Staple Line Reinforcement consists of a thin multi-layer strip of SIS, pre-coated with an adhesive that eliminates the need for a separate adhesive (e.g. hydrogel) to affix the device to surgical stapler jaws. The single-use device is provided on a foam applicator and suspended in a form-fitting tray before being sealed in a foil pouch and sterilized (E-beam). The material composition, general manufacturing processes, packaging configuration and sterilization method of the subject device are identical to the predicate, SURGISIS® SLRTM Staple Line Reinforcement (K070405).

Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

This document is a 510(k) premarket notification decision letter and summary for a medical device called "Biodesign® Staple Line Reinforcement." It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report with specific performance metrics for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, performance data with specific metrics (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

The document discusses:

• Device: Biodesign® Staple Line Reinforcement (a surgical mesh).
• Purpose: Buttressing and reinforcing staple lines during various surgical procedures (lung, gastric, small bowel, colon/colorectal).
• Comparison to Predicate: The core of the submission is to show the device is substantially equivalent to the SURGISIS® SLRTM Staple Line Reinforcement (K070405). The key point is that the subject device is identical to the predicate in materials, manufacturing, intended use, and mode of action, with the only modification being the addition of thinner configurations.
• Performance Data Mentioned:
  • Biocompatibility testing: Leveraged from the predicate device as materials and manufacturing are identical.
  • Non-Clinical testing: "Product verification testing was performed on sterilized finished devices to evaluate the mechanical performance of the subject device for its intended use. Staple line leakage testing confirms that the Biodesign® Staple Line Reinforcement provides adequate staple line buttressing..."

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study details for an AI-driven medical device, as it describes a traditional surgical mesh device seeking 510(k) clearance based on substantial equivalence to an existing product, primarily through material and mechanical performance validation rather than clinical or AI algorithm performance.

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