(56 days)
The Harmonic ACE™ Curved Shears with Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic ACE™ Curved Shears with Hand Control is a sterile, single patient use instrument consisting of a pistol grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level) on both sides of the grip housing. The grip housing has an integrated audible/tactile mechanism for indicating full trigger closure. The instrument has a rotating shaft with a curved blade and clamp arm and is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument is available in 23 cm and 36 cm lengths with a shaft diameter of 5.5 mm and a 15 mm active blade length.
The provided text describes a medical device, the Harmonic ACE™ Curved Shears with Hand Control, and its 510(k) summary for market clearance. However, it does not contain any information regarding acceptance criteria, performance studies with specific metrics, sample sizes, expert involvement, or any of the detailed data requested in your prompt.
The document only states the following regarding performance:
"Bench testing and pre-clinical laboratory evaluations were performed to demonstrate that the device performs as intended."
This is a very general statement and does not provide any quantifiable data that can be used to populate the table or answer the specific questions about a study design.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The information you're asking for would typically be found in a more detailed pre-market submission or a published study, which is not present in this 510(k) summary.
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