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The Single Use Endoscopic Linear Cutters and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

The Single Use Curved Cutters are intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and sketal muscle), gynecologic, urologic, and thoracic surgical procedures.

The Single Use Circular staplers have application throughout the alimentary tract for the creation of end-toside and side-to-side anastomoses in abdominal or thoracic surgeries.

The Single Use Linear Staplers and Reloads have application in transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Single Use Linear Cutters and Reloads have application in abdominal, gynecological, thoracic and pediatic surgery transection, resection and the creation of anastomoses.

The Single Use Hemorrhoidal Staplers have application for general treatment of hemorrhoids.

The Single Use Curved Cutters place four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 4.8mm staple size.

Single Use Circular staplers place a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 27mm and 33mm three specifications. The staple is available in two specifications which are 4.8mm, 5.2mm to be used per different thickness of the tissue.

Single Use Endoscopic Linear Cutters and Reloads place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in three staple sizes to accommodate various tissue thicknesses: 2mm-3mm, 4mm-5mm. The device may be reloaded and fired up to 8 times in a single procedure.

Single Use Linear Staplers and Reloads place a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 100mm staple line length for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 7 times for a total 8 firing in a single procedure.

Single Use Linear Cutters and Reloads place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 7 times for a total 8 firings in a single procedure.

Single Use Hemorrhoidal Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 32mm, 34mm two specifications. The staple size is 4.0mm. It cannot be reloaded.

The provided text is a 510(k) summary for surgical staplers and does not describe an AI medical device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, particularly in the context of AI, cannot be found in this document.

The document discusses the substantial equivalence of various surgical staplers (curved cutters, circular staplers, linear cutters, linear staplers, and hemorrhoidal staplers) to previously cleared predicate devices (K131511 and K111825). The substantial equivalence is based on non-clinical tests.

Here's what can be extracted, even without AI context:

1. A table of acceptance criteria and the reported device performance:

   The document provides comparative tables for the proposed devices against predicate devices, focusing on technological characteristics. It doesn't explicitly state "acceptance criteria" but lists parameters like "Closed staple height" and describes the proposed device's values which are compared to the predicate.

   • For Single Use Curved Cutters (Table 1):

     • Parameter: Closed staple height
     • Proposed Device Performance: 2.0mm
     • Predicate Device 1 Performance: 1.9mm
       (Note: Other parameters like cutting mechanism, operation principle, safety mechanism, patient-contact material, sterilization, endotoxin limit, and labeling are stated as "Same" or similar, implying they meet the predicate's established performance.)

   • For Single Use Circular Staplers (Table 2):

     • Parameter: Closed staple height
     • Proposed Device Performance: 2.0mm, 2.2mm
     • Predicate Device 1 Performance: Same (implies 2.0mm, 2.2mm or comparable)

   • For Single Use Endoscopic Linear Cutters and Reloads (Table 3):

     • Parameter: Closed staple height
     • Proposed Device Performance: 0.8-1.5mm, 1.5-2.25mm, 2.25-3.0mm
     • Predicate Device 2 Performance: Same (implies the same ranges)

   • For Single Use Linear Staplers and Reloads (Table 4):

     • Parameter: Closed staple height
     • Proposed Device Performance: 1.5mm, 2.0mm
     • Predicate Device 1 Performance: 1.5mm, 1.8mm

   • For Single Use Linear Cutters and Reloads (Table 5):

     • Parameter: Closed staple height
     • Proposed Device Performance: 1.5mm, 2.0mm
     • Predicate Device 1 Performance: 1.5mm, 1.8mm

   • For Single Use Hemorrhoidal Staplers (Table 6):

     • Parameter: Closed staple height
     • Proposed Device Performance: 2.0mm
     • Predicate Device 1 Performance: 1.9mm

2. Sample size used for the test set and the data provenance:

   The document states "Bench test was conducted on swine stomach and intestine tissue for both proposed device and predicate device to determine substantially equivalence." It does not specify the sample size (number of tissues, number of firings, etc.) used for these bench tests. Data provenance is implied to be laboratory testing on swine tissue. It's a retrospective comparison against predicate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This is not applicable as the device is a surgical stapler, not an AI device requiring expert ground truth for classification or detection. The ground truth for device performance would be the physical measurements and observations during bench testing.

4. Adjudication method for the test set:

   Not applicable for this type of device and testing.

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:

   Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   The ground truth for the non-clinical tests would have been objective physical measurements and observations (e.g., precise measurements of staple height, visual inspection of staple formation, force measurements, seal strength tests, etc.) on the swine tissue.

8. The sample size for the training set:

   Not applicable. There is no AI model, hence no training set.

9. How the ground truth for the training set was established:

   Not applicable. There is no AI model, hence no training set and no ground truth establishment for it.

Summary of the study conducted (Non-Clinical Tests):

The study was a series of non-clinical, bench tests conducted on swine stomach and intestine tissue. These tests aimed to demonstrate substantial equivalence to predicate devices by assessing:

• Pressure Resistance Test
• Closed Staple Height Test
• Staple Formation Test
• Force Required to Fire Stapler Test

Additionally, the device underwent biological evaluation according to ISO 10993 (cytotoxicity, irritation, delayed-type hypersensitivity), bacterial endotoxin tests, seal strength tests (ASTM F 88/F88M-09, ASTM F1140/F1140M-13), and sterilization dose establishment (ISO 11137-2: 2013). No clinical studies were included in this submission.

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