OtoCompanion (Version 1.0)
Ironsides Medical, Inc.OtoCompanion is a software tool that uses artificial intelligence to help doctors detect fluid behind the eardrum in children and young adults. By analyzing images from an otoscope, it supports early diagnosis of ear infections and helps clinicians make more informed decisions.
Intended Use
OtoCompanion software is intended to accurately detect the presence of middle ear fluid (e.g., otitis media with effusion) that may be associated with acute ear infection. The instrument is designed for use by doctors and other medical professionals on pediatric patients (6 months to 21 years).
Technology
OtoCompanion is a standalone, AI-enabled software application (SaMD) using convolutional neural networks to analyze otoscopic images and classify them as 'Fluid Present' or 'Dry'. The software runs on macOS, works offline, processes high-resolution images from the Karl Storz IMAGE1 HD video endoscopy system, and provides segmentation overlays for clinician review.
Performance
Performance testing included software verification/validation to IEC 62304, internal algorithm testing (n=460 images: 96.1% sensitivity, 97.0% specificity), and a multi-site clinical validation with 181 ears from 93 pediatric patients. Using surgical confirmation as ground truth, the primary clinical analysis showed sensitivity of 97.8%, specificity of 88.8%, and overall accuracy of 93.4%. No device-attributable adverse effects were observed.
Predicate Devices
No predicate devices specified
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