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The Bovie Suture Remover is used to perform suture removal procedures in health care facilities and veterinary offices. The suture removal procedures in which the sutures are located externally on the surface of the skin.

The Suture Remover consists of a rechargeable power handle, charging stand, and a sterile, single-use kit distributed in a multipack. The single-use kit includes three components, two of which are Class I devices (forceps and gauze) commonly used in predicate suture removal kits. The forceps and gauze components are substantially equivalent to those included in other Class I, Premarket notification-exempt devices. The single-use tip component is included in the sterile kit. After the handle is charged, the tip is attached to the power handle. The bottom of the tip is placed flat against the sutured skin surface so that the tip filament only touches the suture. The button is pressed, delivering heat to the filament for about 0.5 second prior to deactivating. This process is completed for all sutures, after which the suture threads are easily removed using the supplied forceps. Using a heated filament to cut the suture provides an advantage over the use of scissors to cut the suture because pulling of the suture prior to the cut is minimized.

This document is a 510(k) premarket notification for the Bovie inaFlash™ Suture Remover. It does not contain information about specific acceptance criteria, a study proving the device meets said criteria, or detailed performance metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is the basis for 510(k) clearance, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text. The document states that "Electromagnetic Compatibility testing in accordance with EN 60601-1-2 was successfully performed" and "Hazard analysis evaluations were also performed," but it does not provide the specific acceptance criteria or results of these tests, nor does it detail a clinical performance study.

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