(31 days)
ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX™ 45 Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The ECHELON FLEX™ 60 Powered Plus instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
I am sorry, but based on the provided text, there is no information about a study that proves a device meets acceptance criteria related to AI or image analysis. The document is a 510(k) premarket notification for surgical staplers and only mentions bench testing to demonstrate performance and substantial equivalence to predicate devices. It explicitly states:
- "Clinical studies were not required to demonstrate substantial equivalence."
- "All verification requirements met criteria for success. The determination of substantial equivalence relied on testing including bench studies that evaluated consistent staple formation."
Therefore, I cannot provide the requested details regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document. The document describes a traditional medical device (surgical stapler) and its regulatory clearance process, not an AI-powered diagnostic or image analysis device.
§ 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.