AusculThing ACC
AusculThing OyAusculThing ACC is an AI-powered decision support software that analyzes heart sounds recorded by an electronic stethoscope to help healthcare providers distinguish between normal and abnormal heart murmurs. It provides instant, automated analysis and visual and acoustic feedback to support clinical evaluation in both adult and pediatric patients.
Intended Use
AusculThing ACC software is a decision-support software for healthcare providers to record, display, and analyze acoustic heart signals from electronic stethoscope recordings on adult and pediatric patients, categorizing heart sounds as either 'abnormal' (any murmur) or 'normal'. It supports but does not replace clinical diagnosis.
Technology
AusculThing ACC runs on a mobile app connected to an FDA-cleared electronic stethoscope (Thinklabs One). It records heart sound signals and analyzes them using an AI-based neural network algorithm trained on a proprietary echocardiogram-validated dataset. Results classifying heart sounds are displayed to users for decision support.
Performance
The AI algorithm was validated on 519 heart sound recordings from 133 patients (both pediatric and adult) against echocardiogram diagnoses as the gold standard. The algorithm showed sensitivity of 90.5%, specificity of 96.0%, and accuracy of 92.5%, demonstrating comparable or better performance than the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/24/2023
3 months - 2
FDA Approval
7/12/2023
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