Search Results

The BioWarm" is indicated for use as an ancillary device for the OSStaple" staple system.

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm electrode and will cease if the button is released prior to the automatic cessation by the circuitry

I am sorry but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text describes modifications to a bone staple heating system and its substantial equivalence to previously approved devices. It does not include details on acceptance criteria, device performance results, study methodologies, sample sizes, ground truth establishment, or expert involvement for performance evaluation.

Ask a specific question about this device