"Breakthrough" devices have to be devices which show a significant improvement to quality of life over existing treatments for "life threatening or irreversably debilitating" conditions, using breakthrough technology in a space where an existing device doesn't exist yet.

So it's less "we made a better pacemaker that uses ChatGPT" and more "this new ventilator can keep people alive even when their lungs are filling with fluid and they're going to die otherwise".