Intended Use

The Tyto Insights for Crackles Detection is an over-the-counter AI-enabled decision support software system used in evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes lung acoustic signals recorded by the FDA-cleared compatible Tyto Stethoscope and identifies recordings where abnormal lung sound 'Crackle' is suspected.

Technology

This is a cloud-hosted AI software system comprising an Application Server, Algorithm Server, and Web Server. It processes lung sound recordings from the FDA-cleared Tyto Stethoscope via telehealth server API communications. The core AI algorithm is a convolutional recurrent neural network (CRNN) trained to detect crackles from audio input segments up to 12 seconds. The system provides a positive or negative crackle detection result to both patients and clinicians through a web interface.

Performance

Clinical evaluation on 446 sound recordings from 445 patients (age 2+) showed high performance with Area Under the Curve (AUC) of 0.97. Sensitivity was 0.72 and specificity 0.99 compared to ground truth established by expert pulmonologists. The device was demonstrated non-inferior to clinical readers in detecting crackles in lung sounds recorded using the Tyto Stethoscope.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    2/28/2024

    4 months
  • 2

    FDA Approval

    7/2/2024

Other devices from Tyto Care Ltd.

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