Interpreting AI results February 24, 2023 20:24 Updated Who is this for? ✓ Plan: SENSORA™ platform with Structural Murmur Detection ✓ Role: Program Admin, Clinician Overview When the Eko App is connected and used with the Eko CORE digital stethoscope, the Eko Analysis Software (EAS) and SENSORA with Structural Murmur Detection automatically check for murmurs during a cardiac exam or spot check. These artificial intelligence (AI) algorithms are both FDA cleared. Once the recording is complete, the Eko App summarizes any findings, including potential murmurs detected. The algorithms used to detect murmurs aren't accessed by the Eko CORE alone. Users must be connected to the newest version of the Eko App for iPad. Important Outputs of the Eko analysis are not a diagnosis, but are intended to aid the clinician in reaching a diagnosis. AI results found The AI results show on the summary screen after a spot check or full cardiac exam. An example is shown below, along with a description of each feature. Recording location: Left upper sternal border (LUSB), right upper sternal border (RUSB), left lower sternal border (LLSB), cardiac apex (APEX). AI finding: No structural murmur detected, Structural murmur detected, or Poor heart sound signal. If a structural murmur is detected, the output shows whether it's systolic, diastolic, or continuous. A yellow exclamation point icon shows next to a recording where a structural murmur is identified by the AI, and an average waveform shows above the PCG for that position. About average waveform If a structural murmur is detected for a position, an average waveform shows above the PCG tracing for that position. If no structural murmur is detected for a position, then only the PCG waveform shows. The average waveform highlights the location of a murmur within a heartbeat. The AI analyzes and averages the individual heartbeats with the PCG and creates the illustration. To the right of the average waveform is an illustration of a waveform with no murmur for comparison. No murmur detected If no murmur is detected or if an innocent murmur is detected, it's classified as No Structural Murmur Detected. No recording taken If no recording is taken, it's shown as No Recording Taken. In that case, no AI results are provided for that location. Poor quality recording If a recording is poor quality, the recording for that location is shown as Poor Heart Sound Signal. Poor quality recordings can happen for a variety of reasons, such as external noise or poor placement of the CORE. If a signal is poor quality, no AI results will be returned for that recording. Additional information on murmur characterization When used with the Eko CORE digital stethoscope, the cloud-based EAS and SENSORA software analyze heart sounds and phonocardiograms to determine murmur presence and characterization. The database used in the training and testing of SENSORA is one of the world's largest repositories of clinically validated heart sounds. Among adults 18 years and older, SENSORA identifies structural murmurs with a sensitivity of 90.2% and a specificity of 90.6%. Murmur classification increases in sensitivity for higher grade murmurs, such as murmurs that might have a higher likelihood of requiring follow-up care. LBL: 408 Rev.3.0 Date of Issue: February 21, 2023
