LUMYS (V1)

LUMYS (V1) is medical display software for 3D image visualization and surgical planning using CT scan data. It displays stereoscopic 3D images on a Microsoft HoloLens 2 headset worn by a surgeon, who can share visualizations with remote clinicians for pre-surgical annotation and consultation. The device is not for primary diagnosis but serves as an adjunct for clinician decision-making.

Both LUMYS and the predicate device (Cysware 4H and Cysart 4H) use Microsoft HoloLens 2 as the user interface in the operating room and share identical intended uses. When differences exist between the devices, optical and display bench testing and segmentation algorithm validation demonstrate substantial equivalency without negative effects on safety and effectiveness.

IEC 62304/A1:2016, IEC 81001-5-1:2021, IEC 82304-1:2016 (software development and security), IEC 62366-1:2015+Amd1:2020 (usability), ISO 14971:2019 (risk management), and IEC 63145-20-20 (optical testing).

LUMYS has identical intended use and technological characteristics to the predicate device, both importing, visualizing, annotating, and segmenting medical images for 3D display in mixed reality. Testing demonstrated all specifications met acceptance criteria, with segmentation algorithm error under 0.9 mm and optical testing confirming DICOM visualization suitability on the HoloLens platform. Since both devices perform the same function with the same core technology and validated performance, LUMYS raises no additional safety or effectiveness questions compared to the legally marketed predicate.