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The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.

The provided text does not describe the acceptance criteria or a study proving that a device meets specific acceptance criteria related to an AI/ML medical device.

Instead, the document is an FDA 510(k) summary for a linear cutting stapler and loading unit, which is a physical surgical device, not an AI/ML product. The summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests (e.g., biological evaluation, seal strength, ex-vivo tissue tests) and comparisons of technological characteristics (e.g., product code, intended use, staple height, materials).

Therefore, I cannot extract the information required for an AI/ML device study, such as sample size for test sets, data provenance, number of experts, MRMC studies, or ground truth establishment methods for an AI model.

The sections that are present in the document and relate to device performance are:

Acceptance Criteria/Performance Testing (Non-Clinical Tests):

• Ex-vivo tissue test was conducted on porcine stomach and intestine tissue.
  • Test items evaluated: Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test, and Force Required to Fire Stapler Test.
• Jugular vein test was conducted on a porcine model for thin tissues (less than 2.5mm staple height).
  • Evaluated: Burst pressure and closed staple formation.
• Biological evaluation: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), USP 43-NF38 (Pyrogen Test), USP 42-NF 37 (Bacterial Endotoxins Tests).
• Material properties: ASTM F88/F88M-15 (seal strength).
• Sterilization validation: ISO 11137-2 (sterilization dose).

Reported Device Performance:

The document states, "The test results demonstrated that the proposed device complies with the following standards" and lists the standards. It implicitly states that the performance met the requirements of these standards. For the ex-vivo and jugular vein tests, it notes what was evaluated but does not provide specific quantitative results or acceptance criteria values for these tests in this summary.

Regarding AI/ML specific information, the document explicitly states:

• "No clinical study is included in this submission." This means no human-in-the-loop or standalone clinical performance trials were conducted or are reported here, which would be typical for AI/ML validation.

In summary, none of the specific AI/ML related questions can be answered from this document because it pertains to a mechanical surgical stapler, not an AI/ML medical device.

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