Evaluation of the AudibleHealth Dx AI/ML-Based Dx SaMD Using FCV-SDS in the Diagnosis of COVID-19 Illness

Summary

The AudibleHealth Dx is a diagnostic software as a medical device (Dx SaMD) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes.

This study will evaluate the performance of the AudibleHealth Dx in comparison to a standard of care Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test for the diagnosis of COVID-19. Bidirectional Sanger sequencing will be used to reduce the rate of false negative and false positive results.

A secondary purpose of the study will be usability testing of the device for participants and providers.

Conditions

• COVID19

Interventions

DIAGNOSTIC_TEST

Diagnostic Software as Medical Device

AudibleHealth Dx is an investigational Dx SaMD consisting of an ensemble of software subroutines that interacts with a proprietary database of signal data signatures (SDS) using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for diagnostic purposes. The intended use for the AudibleHealth Dx AI/ML-based Dx SaMD using FCV-SDS is for the diagnosis of acute and chronic illnesses. The AudibleHealth Dx is a cloud-based AI/ML (locked ML) diagnostic software as medical device (Dx SaMD) with a mobile app based graphical user interface (GUI) designed to operate with COTS Android Operating System (OS) and Apple OS based mobile devices. The AudibleHealth Dx system uses a forced cough vocalization (FCV) signal data signature (SDS) to diagnose COVID-19 illness in ambulatory adults. Results are sent to ordering physicians, State Health Departments, and participants using Health Level 7 (HL7) compliant communication protocols.

Sponsors & Collaborators

• University of South Florida

  collaborator OTHER

• R. P. Chiacchierini Consulting, LLC

  collaborator INDUSTRY

• Analytical Solutions Group, Inc.

  collaborator UNKNOWN

• Renaissance Worldwide Solutions, LLC

  collaborator UNKNOWN

• Medical & Regulatory Affairs Specialists, LLC

  collaborator UNKNOWN

• AudibleHealth AI, Inc.

  lead INDUSTRY

Principal Investigators

• Karl Kelley, MD · RAIsonance, Inc.

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-10

Primary Completion

2022-05-03

Completion

2022-05-03

FDA Device

Yes

Countries

• United States

Study Locations