-Replace the O-Arm to Dominion DVIS -Replace the 3D imaging to 3D real-time Fluoroscopic -Add 16 slice CT scan(plenty out there in the market already) - Added funcationaliy for DVIS
Intended Use The O-ArmnTM Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-ArmTm Imaging System is compatible with certain Image Guided Surgery Systems.
Similarities and comparison section will be similar to one described in the document(second link above - 2nd link)
Performance data is going to similar to one what they listed in the 510k in the document.(second link above - 2nd link) (2 Radiologists review comparing the images in different modalities 2D, 3D and CT. ) we all know safety doesn't matter at all( we are far better than industry standard - 50% less to at the max equal to the industry standard) if the reviewer OK with radiologist review, we will get approval(effectiveness part of it)