HipCheck

HipCheck provides real-time, intra-operative quantitative measurements like the alpha angle for FAI surgery by applying an AI-driven image processing algorithm to fluoroscopic images. The accompanying HipMap FAI Analysis tool utilizes pre-operative CT scan data to generate detailed patient-specific 3D morphological reports, aiding in comprehensive surgical planning and decision-making.

HipCheck is a software system designed to aid surgeons in femoroacetabular impingement (FAI) procedures for skeletally mature patients. It operates intra-operatively, processing static fluoroscopic X-ray images to enable the superposition of virtual measurement tools, primarily for determining the alpha angle, an indicator of femoral head cam deformity. The system includes a mobile touchscreen tablet for displaying these visualizations. A complementary component, HipMap FAI Analysis, is a pre-operative tool that processes CT scans to generate patient-specific reports. These reports provide a detailed morphological analysis of the hip, including 3D reconstructions, measurements, and visualizations that describe potential FAI, hip impingement, and stability, supporting pre-operative clinical decision-making by surgeons or radiologists. The HipCheck system employs image processing algorithms, featuring an AI/Machine Learning model for detecting the femoral head and neck from fluoroscopic images. Standalone performance testing of this AI/ML model demonstrated high accuracy, correctly detecting the presence or absence of a hip with a 97.5% lower bound confidence. It precisely located femoral landmarks, with head center coordinates accurate to within approximately ±3.3-4.8% and neck angle within ±13.6-15.4°, validated across various image quality and anatomical subgroups. The HipMap FAI Analysis component relies on segmentation of pelvic CT scans for its 3D analyses; its segmentation accuracy and reliability were evaluated by comparing segmentations from Stryker personnel using HipMap software against those from third-party personnel using established software, along with intra- and inter-rater reliability assessments. Design validation further confirmed that users could effectively utilize the HipCheck tools as intended for alpha angle measurement and visualization during simulated use.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the AI/ML model's performance in HipCheck for femoral landmark detection change across varying patient BMIs or in the presence of orthopedic implants, which might alter fluoroscopic image characteristics?; What were the specific Dice similarity coefficients or surface distance errors for the HipMap FAI Analysis segmentation when benchmarked against the reference software and what was the inter-rater variability in these metrics?; What is the reported impact of using HipCheck's intra-operative alpha angle and HipMap's pre-operative analysis on surgical times, extent of bone resection, or short-term patient-reported outcomes for FAI procedures?; How does the system account for potential C-arm distortion or calibration variations during intra-operative fluoroscopic image acquisition when calculating measurements like the alpha angle?; Could the AI/ML model in HipCheck be adapted or retrained to identify other relevant anatomical structures or pathologies in the hip joint beyond the femoral head/neck for FAI?