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HEARTBEAM AIMIGo SYSTEM:

The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

HEARTBEAM 12-L ECG SYNTHESIS SOFTWARE:

The HeartBeam 12-L ECG Synthesis Software synthesizes a 12-L ECG from the HeartBeam AIMIGo 3-Leads (in three-directions) recording device, producing a visual 12-L ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-L ECG.

The synthesized 12-L ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-L ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-L ECG. The 12-L ECG Synthesis Software is intended for adult use only.

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3-lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGo™ System is provided by prescription only.

The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

• Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
• Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed by a clinician via the Clinician Portal for review and manual interpretation.

This submission includes a modification to the HeartBeam System involving the addition of a new software feature, the HeartBeam 12-L Synthesis Software. Like the HeartBeam AIMIGo system, the patient-activated recording of a 3-L ECG is obtained and the HeartBeam 12-L Synthesis Software can synthesize a 12-L ECG signal from the 3-lead ECG signal recorded from the HeartBeam AIMIGo Device of the cleared system. The synthesized 12-L ECG output signal is intended to be an adjunct set of ECG information that complements but does not replace a standard 12-L ECG, to aid in the manual assessment of non-life-threatening arrhythmias.

The synthesized 12-L ECG signal has not been studied or evaluated for safe and effective use for other cardiac conditions outside of manual non-life-threatening arrhythmias and is contraindicated for the assessment of any urgent, serious, or life-threatening conditions or arrhythmias.

The new software works with the HeartBeam system, which retains all functionalities and performance characteristics of the previously cleared system. No changes to the hardware, intended use, or fundamental technological characteristics were made to incorporate the new software. Additionally, the synthesis software works with the standard 12-L ECG system, the EDAN SE-1515 DX-12. The EDAN SE-1515 DX-12 systems provide a patient's compatible standard 12-L ECG signal, which is used as one of the inputs for the synthesis software to create the personalized transformation matrix for each patient.

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The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only.

The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

• . Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
• Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation.

Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter).

The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation.

The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

The provided text addresses the clinical study, but lacks specific details on the acceptance criteria and the comprehensive study data. Based on the information available, here's a breakdown of what can be inferred and what is missing:

The HeartBeam AIMIGo™ System Clinical Study Summary

The HeartBeam AIMIGo™ System underwent two clinical studies to support its 510(k) submission, confirming its substantial equivalence to the predicate device (AliveCor KardiaMobile 6L) and a reference device (VectraCor Universal Smart ECG).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of acceptance criteria with corresponding performance metrics. It indicates that "All study endpoints were met" for both clinical studies, implying that the device's performance reached the predefined success criteria. However, the specific metrics and targets are not detailed.

Inferred Performance Goals (based on study objectives):

• Pivotal Study: To demonstrate clinical equivalence of ECG waveforms between AIMIGo 3-L VECG and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias. This implies high level of agreement or correlation in ECG waveform morphology and characteristics relevant for arrhythmia detection.
• Device Positioning Validation Study: To validate that within a predetermined range of distance, direction, and orientation from the recommended position, the AIMIGo 3L VECG output signal characteristics remain unaffected when compared to a simultaneously recorded standard 12L ECG signal, for interpretation of non-life-threatening arrhythmias. This suggests performance robustness under varied positioning.

Observed Device Performance:

• "All study endpoints were met" for both the Pivotal Study and the Device Positioning Validation Study. This is the only reported device performance.

Table Structure (Hypothetical, as specific criteria are not provided):

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample size for the test set used in either clinical study. It only refers to a "Pivotal Study" and a "Device Positioning Validation Study."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It states that the Device Positioning Validation Study was "prospective." The nature of the "Pivotal Study" (retrospective or prospective) is not explicitly mentioned, though "clinical equivalence" studies usually involve prospective data collection.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the number of experts used to establish the ground truth or their qualifications. It mentions that the device is "intended to be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional." This implies that qualified medical professionals were involved in the interpretation, but the details of their roles in establishing the ground truth for the study are absent.

4. Adjudication Method for the Test Set

• The document does not provide information on the adjudication method (e.g., 2+1, 3+1, none) used for the test set's ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance. The HeartBeam AIMIGo™ System explicitly states, "The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional." This means it acts as a data recorder and viewer, not an AI-powered diagnostic tool assisting human readers. Therefore, an MRMC study on AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

• The document states, "The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems." This confirms that no standalone (algorithm only) performance was conducted, as the device's function is solely to record, store, and transfer ECG data for manual interpretation.

7. Type of Ground Truth Used

• The ground truth in these studies would implicitly be established by the manual interpretation of the reference standard 12-lead ECG by qualified medical professionals. The pivotal study aimed to show "clinical equivalence of ECG waveforms between AIMIGo 3-L VECG (investigational device) recordings and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias." This indicates that the 12-L ECG interpretation served as the ground truth against which the AIMIGo's output was compared.

8. Sample Size for the Training Set

• The HeartBeam AIMIGo™ System is presented as a medical device that records and transmits ECG signals for manual interpretation, not a device that employs a machine learning algorithm requiring a separate "training set." Therefore, a training set in the AI/ML context is not applicable.

9. How Ground Truth for Training Set was Established

• Since a training set (for an AI/ML algorithm) is not applicable, the method for establishing its ground truth is also not applicable.

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