VEA Align; spineEOS

VEA Align is cloud-based software for orthopedic assessment that uses 2D X-ray images from EOS imaging systems to display interactive anatomical landmarks on frontal and lateral images, enabling users to assess patient-specific global alignment and analyze spinal deformities, degenerative diseases, and lower limb alignment disorders through angle and length measurements in patients aged 7+. spineEOS is cloud-based software that assists healthcare professionals with preoperative planning of spine surgeries by providing access to EOS images with 3D datasets, measurements, and surgical planning tools to define patient-specific surgical strategies.

Both devices are cloud-based software classified as medical image management and processing systems (21 CFR 892.2050). VEA Align uses machine learning-based algorithms to generate initial landmark placement on 2D X-ray images with user adjustment capability, operates on Windows and MAC, and provides color-coded clinical parameters compared to normative values. spineEOS operates as a web browser-based application (Chrome/Edge versions 130+) requiring high-speed internet, includes pediatric and adult workflows with age-based access restrictions, and provides additional clinical parameters (L1PA, T4PA, axial rotation, disc height, disc segmental lordosis) beyond the predicate.

Not stated in this summary.

The devices are substantially equivalent because they maintain identical indications for use, intended use, regulatory classification, user populations, and core functionalities as the predicate K240582. AI validation testing demonstrated the VEA Align algorithm meets acceptance criteria (median error ≤3mm, 3rd quartile ≤5mm) across 361 patient test cases with diverse demographics and clinical conditions, matching predicate performance. Both devices underwent verification (design input, unit testing, integration), validation (multifunctional requirements, usability testing, clinical parameter reproducibility), and minor additions like the pediatric workflow and expanded clinical parameters in spineEOS do not alter the fundamental design, safety, or intended use compared to the predicate.