(108 days)
For coagulation, transection, and resection of tissue. The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators.
delivers a line of bipolar coagulation . followed by two double-staggered rows of staples . . while simultaneously dividing the tissue. A safety lockout feature is incorporated into the cartridge. The line of bipolar coagulation delivered is approximately 37mm long with a 37mm staple line length, and a cut length of 35mm. A staple retaining cap on the cartridge protects the staples during shipping and transportation. The instrument is reloadable with a universal cartridge and is acceptable for use on tissue which can be compressed to a thickness of 2.0mm or less. The instrument is designed to be reloaded seven times for a maximum of eight firings per instrument. The ENDOPATH® EZ-RF Linear Cutter and Coagulation device is designed to have an integral Indicator Light on the Linear Cutter or an external Indicator Light device. The Linear Cutter connects to an RF electrosurgical generator with an integrated cord from the Linear Cutter to the generator or the external Indicator Light device. The Indicator Light device illuminates when current is flowing above a reference current threshold.
This is not an AI/ML medical device. The provided text describes a surgical stapler and coagulation device, the ENDOPATH® EZ-RF Linear Cutter and Coagulation device, and its pre-clinical laboratory evaluations. It does not mention any AI or machine learning components, nor does it present any acceptance criteria or studies related to AI/ML performance.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, or AI/MRMC study results, as these concepts are not applicable to the provided device description.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.