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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 Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

The subject device consists of a thin multi-layer strip of SIS, pre-coated with a ready-to-use contact adhesive that eliminates the need for a separate adhesive (hydrogel), or activation of the adhesive through rehydration to affix the device to surgical stapler jaws. The single-use implant device is provided to the point of use with a protective liner covering the adhesive which has been assembled onto a foam carrier which is suspended in an alignment tray sized for the jaws of a surgical stapler. The completed device, liner, carrier, and alignment tray unit is then sealed in a foil pouch with an integrated humidity control feature and terminally E-beam sterilized. In order to accommodate a variety of commercially available surgical staplers the device is available in configurations measuring from 0.05mm to 0.6mm in thickness, and in nominal (unfolded) device lengths ranging from 76 mm to 176 mm in length and up to 12 mm wide. 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) summary for the Biodesign® Staple Line Reinforcement device. It describes the device, its intended use, and compares it to a legally marketed predicate device (K170945) to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of "Product verification testing" and "Staple line leakage testing" but does not explicitly state numerical acceptance criteria for these tests. Instead, it describes general findings.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide specific sample sizes for the "Product verification testing" or "Staple line leakage testing". It states "representative SHS conditioned sterilized finished devices" and "representative SHS conditioned packaging system samples" were used.

The data provenance is not explicitly stated in terms of country of origin. The testing appears to be non-clinical bench testing conducted by the manufacturer, Cook Biotech Incorporated, which is a U.S.-based company (West Lafayette, IN). All tests mentioned are retrospective (bench tests performed on the device).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. The device is a physical medical device (surgical mesh), and its performance is evaluated through objective physical and biological tests (mechanical performance, leakage, biocompatibility). There is no "ground truth" derived from expert interpretation of images or clinical data in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above (physical device testing, not expert-based assessment).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device is a surgical mesh for physical reinforcement, not an AI-assisted diagnostic or clinical decision support tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance claims of this device is based on objective scientific and engineering measurements in benchtop and laboratory settings:

• Mechanical performance: Measured physical properties and behaviors under simulated surgical conditions.
• Staple line leakage: Measured leakage rates or other objective indicators of buttressing effectiveness.
• Biocompatibility: Results from standardized ISO 10993 in vitro and in vivo biological tests.
• Packaging and shelf life: Measured integrity of packaging and stability of the product over time under defined conditions.

8. The Sample Size for the Training Set:

This information is not applicable because the device is a physical medical device and does not involve AI or machine learning that requires training data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

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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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