(131 days)
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line buttressing material. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument that delivers staples while simultaneously dividing tissue between rows. The instruments provide a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
The Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler is a sterile, single patient use instrument that delivers staples but does not divide tissue. The instruments provide a staple line that is approximately 45 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
I am sorry, but based on the text provided, I cannot fulfill your request. The document describes a medical device called Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler, and mentions some "bench testing" that was performed. However, it does not provide:
- A table of acceptance criteria and reported device performance. While it mentions tests performed (staple form quality, staple height, staple line integrity, force to close, compatibility with buttress material, lock out reliability and lockout withstand force), it doesn't list specific acceptance criteria or the numerical results of these tests.
- Details about a study proving the device meets acceptance criteria. It only states that bench testing was performed "to confirm that the subject devices perform as intended and are substantially equivalent to the predicate devices." It lacks the methodology, results, and analysis that would constitute a study proving the device meets specific acceptance criteria.
- Information about sample sizes, data provenance, experts, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets for an AI/algorithm-based device. This document is about a mechanical surgical stapler, not an AI or algorithm-based medical device. Therefore, the questions related to AI/algorithm testing methodologies are not applicable and not present in the text.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.