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The easyLCTM Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.

The easyCSTM Circular Stapler for Single Use has applications throughout the alimentary for end to side and side to side anastomoses.

The easyLCTM Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm length with reload in 2.5mm, 3.8mm and 4.8mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure.

The easyCS™ Circular Stapler for Single Use places 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 is available in 21mm, 29mm, 31mm and 33mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

The provided document is a 510(k) Summary for medical stapling devices (easyLC™ Linear Cutter Staplers and easyCS™ Circular Stapler). It describes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices, but does not include information about clinical studies or acceptance criteria for AI/algorithm performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document indicates:

Clinical Test Conclusion (Section 7):

• "No clinical study is included in this submission."

This means the submission relies entirely on non-clinical (bench and biocompatibility) testing to demonstrate substantial equivalence.

Non-Clinical Test Conclusion (Section 6):
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The tests included:

• Standards Compliance:
  • ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
  • ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
  • ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
  • USP 38-NF 33 Bacterial Endotoxins Tests
  • ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
  • ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
  • USP 39-NF 34 Pyrogen
• Bench Tests (on porcine stomach and intestine):
  • Pressure Resistance Test
  • Closed Staple Dimension Test
  • Staple Formation Test
  • Force Required to Fire Stapler Test
• Biocompatibility Tests:
  • Cytotoxicity
  • Irritation
  • Skin sensitization
  • Pyrogenicity

Ground Truth for Non-Clinical Tests:

• The ground truth for these non-clinical tests is inherently defined by the physical and biological properties being measured (e.g., pressure resistance in standard units, staple dimensions, visual inspection of staple formation, force measurements, and standard assays for biocompatibility). There are no "experts" establishing ground truth in the sense of medical image interpretation; rather, the tests themselves provide objective measurements against established scientific and engineering standards.

Training Set:

• This concept is not applicable as this is a mechanical device, not an AI/ML algorithm.

In summary, the provided document does not contain the information required to answer your questions because it describes the regulatory submission for a physical medical device (staplers) based on non-clinical testing, not an AI-powered diagnostic or assistive device that would have acceptance criteria related to algorithm performance.

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