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The Medaica M1 Telehealth Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Medica M1 Telehealth Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

Device Description

The Medaica M1 Telehealth Stethoscope is designed for use by professional as well as lay users in clinical or non-clinical environments. It enables three types of stethoscope exams: Heart. Lungs and Audio (Audio is for clinician only). The operation process of the Medaica M1 Telehealth Stethoscope uses four (4) primary functional elements:

(1) The Medaica M1 Telehealth Stethoscope.
(2) A patient's web-connected computer on which the Medaica Web Client software is running.
(3) The Medaica Server on which the Medaica server software is running.
(4) A clinician's web-connected computer on which the Medaica Web Client software is running.
The Medaica M1 Telehealth Stethoscope operates either in Patient Store and Forward mode or Live, online mode. Both modes are essentially similar and share the same fundamental steps: performing one or more exams using the Medaica M1 Telehealth Stethoscope, recording the data and sending to a clinician, review of the exams by the clinician, and the user receiving a summary from the clinician presenting his/her assessment and/or recommendations. While in the Patient Store and Forward mode, the Patient can send the recorded data to the clinician whenever convenient for him/her. A Live, online mode can only be executed when the clinician is available online at the same time as the patient.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study dedicated to proving the device meets those specific criteria in the way a clinical performance study for an AI-powered diagnostic device might.

However, based on the Performance Testing section, we can infer some general performance criteria and how they were met:

Here's an attempt to answer your questions based on the available information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (as stated or inferred)
Electrical Safety & EMC	Meets ANSI AAMI ES 60601-1:2005 and A1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11 Edition 2.1 2020-07 Consolidated Version.
Biocompatibility	Meets ISO 10993-1. Specifically, Cytotoxicity, Sensitization, and Irritation tests (per ISO 10993-5 and ISO 10993-10) were successfully conducted.
Stethoscope Acoustic/Signal Performance	Has the required sensitivity and signal-to-noise response over the frequency range of 20Hz to 3,500 Hz.
Software Validation	Successfully validated in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 5, 2011) and IEC 62304:2006/A1:2016.
Usability	Passed a usability study in accordance with Medaica's System Usability Test Protocol and FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016."
Substantial Equivalence	Demonstrates comparable performance to its predicate device (Tyto Stethoscope OTC K181612) and does not raise different questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of diagnostic performance (e.g., patient cases for diagnostic accuracy). The performance testing refers to engineering and regulatory compliance tests. Therefore, there's no information on sample size or data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document outlines performance testing for device functionality, safety, and regulatory compliance, not for diagnostic accuracy evaluated by experts against a ground truth.

4. Adjudication method for the test set
Not applicable, as no diagnostic test set with ground truth established by experts is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Medaica M1 Telehealth Stethoscope is described as an electronic stethoscope for transmitting auscultation sounds. The document does not indicate that it incorporates AI for diagnostic assistance to human readers. Its primary function is data transmission and sound capture.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a stethoscope used by either a lay user or a clinician, with sound data interpreted by a clinician. It's not an AI algorithm performing standalone diagnoses.

7. The type of ground truth used
For the "Stethoscope performance testing" mentioned, the ground truth would likely be established by objective physical measurements (e.g., using calibrated sound sources and measurement equipment) to verify sensitivity, signal-to-noise ratio, and frequency response against established engineering specifications for stethoscopes. For "Biocompatibility" and "Electrical safety & EMC," ground truth is adherence to the specified international standards.

8. The sample size for the training set
Not applicable. The device is not an AI algorithm requiring a training set in the machine learning sense.

9. How the ground truth for the training set was established
Not applicable.

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