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Ortho AI is an image-processing software indicated to assist in making measurements for a total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery. It is intended to assist in the measurement of x-ray images by measuring lengths, angles and position of implants relative to the bone structures of interest provided, that the points of interest can be identified from radiology images. The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. The software is not for primary image interpretation. The software is not for use on mobile phones. Intended patient population: Adult patients >=22 years old, with appropriate imaging, undergoing primary hip replacement, primary knee replacement, and lumbar spine surgery. Intended user population: orthopaedic surgeons who perform hip and knee replacement, and orthopaedic/neurosurgeons who perform lumbar spine surgery.

Ortho AI is a software as a medical device (SaMD) system that provides preoperative planning data for hip replacement surgery, knee replacement surgery, and lumbar spinal fusion surgery using AI/ML models that are semi-automated and interpretable. The software guides the user through a predetermined workflow that begins with the use of preoperative radiographic images as input to the software. As part of this initial preoperative workflow, the software places digital annotations on these preoperative images, which can be modified by the user (semi-automated). The software additionally includes functionality to store user, patient, and case information.