(303 days)
The reprocessed harmonic shears are intended to be used for cutting soft tissue and when control of bleeding and minimal thermal injury is desired. The instruments can be used as un udjunct to or a substitute for clectrosurgery, lasers, and steel scalpels in general, plastic, pediatic, gyncoologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
The harmonic shears are used in combination with a handpiece, generator and torque wrench and are intended to be used for cutting and coagulation of soft tissue during laparoscopic and open procedures. The instruments allow the surgeon to grasp, coagulate and cut soft tissue with one instrument. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter. The instruments are hand-actuated with a shaft and distal tip that can be rotated 360°. The ultrasonic energy is delivered by hand activation or with an optional generator foot switch.
The provided document pertains to the reprocessed Harmonic Shears and does not describe a study involving an AI device or its acceptance criteria. The document is a 510(k) summary for a medical device (reprocessed harmonic shears) and focuses on demonstrating substantial equivalence to predicate devices, rather than the performance of an AI algorithm.
Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study details based on the provided text.
N/A