(90 days)
The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or 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 devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. These devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue during multiple open or minimally invasive surgical procedures. They are intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected.
The Echelon Zebra cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissue. As in the predicate Echclon cartridge, the Zebra cartridges are available in 60 mm lengths. Zebra cartridges will also be available in a 45 mm length for use with the 45mm instruments. There are 70 staples in the 45mm length cartridge and 88 staplers in the 60 mm length cartridge.
Cartridges deliver the staples in a predetermined staple row configuration or pattern in relation to the cut line. The staple row configurations of both the predicate and the new device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the prodicate device is straight. That is to say, all 6 staples are of the same height and formation. The Zebra cartridge staple row configuration is step-wise. This means that of the 6 staples, the two outer most staples are of a taller height and formation than the 4 inner staples.
The provided 510(k) summary for the Echelon Zebra Cartridges is for a medical device (stapling device) and describes its function and comparison to predicate devices. It does not present information about software or AI, nor does it describe specific acceptance criteria, performance metrics, or study designs typically associated with AI/software performance validation.
Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) as it is not present in the provided text.
The text states: "Performance Data. Bench testing was performed to demonstrate that the new device will perform as intended." This indicates that physical bench testing was done for the mechanical device, but no details of that testing, nor any information related to AI or software, are provided.
§ 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.