Prospective Silent Evaluation of AI for Retained Foreign Object Detection

Retained foreign objects, such as surgical sponges, needles, or instruments, are rare but potentially serious complications of surgery. When there is concern that an object may have been left behind, an intraoperative radiograph may be obtained while the patient is still in the operating room. These radiographs can be difficult to interpret because of overlapping surgical equipment, patient positioning, and the need for rapid interpretation. This prospective observational study evaluates an artificial intelligence (AI) system designed to detect retained foreign objects on intraoperative radiographs. Eligible radiographs obtained during routine clinical care will be automatically processed by the AI system in real time for approximately one year. The AI results will not be shown to radiologists, surgeons, or other members of the clinical care team and will not affect patient care. The study will evaluate how accurately the AI system detects retained foreign objects and how reliably and quickly the system operates in a real-world clinical environment.

Inclusion Criteria: * Age 18 years or older. * Undergoing intraoperative radiography during routine clinical care for evaluation of a possible retained foreign object. * Radiographic examination identified using the institutional OR count imaging protocol, including "XR OR COUNT PROTOCOL W/WO POSITIVE CONTROL" or an equivalent institutional protocol label used for OR count imaging during the study period. Exclusion Criteria: * Radiographic examination lacking usable imaging data. * Insufficient clinical or imaging information to establish an adequate reference standard for analysis.