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The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) softwareonly, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present, rather the feature is intended to opportunistically acquire pulse rate data when the data when determined sufficient toward surfacing a notification.

Following this prompt, or based on the user's own initiative, the app is intended to create, record, store, transfer, and display a single-channel ECG. similar to a Lead I ECG. Classifiable traces are labeled by the app as either AFib or sinus rhythm with the intention of aiding heart rhythm identification.

The app is not intended for users with other known arrhythmias, and it is not intended to replace traditional methods of diagnosis or treatment. Users should not interpret or take clinical action based on the device of the of a qualified healthcare professional.

The Samsung ECG Monitor App with Irregular Heart Rhythm Notification (IHRN) Feature is a software as a medical device (SaMD) that consists of a pair of mobile medical apps: one app on a compatible Samsung wearable and the other on a compatible Samsung phone, both general-purpose computing platforms.

When enabled, the wearable application of the SaMD uses a wearable photoplethysmography (PPG) sensor to background monitor bio-photonic signals from the user. The application examines beat-to-beat intervals and generates an irregular rhythm notification indicative of atrial fibrillation (AFib). Upon receiving an irregular rhythm notification or at their discretion, the user can record a single-lead ECG using the same wearable. The wearable application then calculates the average heart rate from the ECG recording and produces a rhythm classification. The wearable application also securely transmits the data to the ECG phone application on the paired phone device. The phone application shows a time-stamped irregular rhythm notification history with heart rate information; ECG measurement history; and generates a PDF file of the ECG signal, which the user can share with their healthcare provider.

Here's a breakdown of the acceptance criteria and the study details for the Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Feature, based on the provided text:

Acceptance Criteria and Device Performance

The document states that Samsung's algorithm performance for the IHRN function is substantially equivalent to the predicate device (Apple IRN Feature DEN180042) at both subject and tachogram levels, indicating these reported values met the acceptance criteria. For the ECG function, the device inherited the performance from the previously cleared Samsung ECG Monitor App (K201168) and thus the reported values were assumed to meet their prior acceptance criteria.

Study Details

2. Sample size used for the test set and the data provenance:

• IHRN Clinical Validation (PPG-based notification):

  • Analyzable Dataset for primary and secondary endpoints: 810 subjects (from 888 enrolled).
  • Tachogram-level assessment: 98 subjects with AFib episodes (over an hour) and 101 subjects with less than an hour of AFib or no AFib were randomly selected from the cardiologist-reviewed subjects. Up to 25 positive tachograms with reference ECG data were randomly selected from these subjects.
  • Data Provenance: The document does not explicitly state the country of origin, but it is a clinical study. The phrasing "All recruited subjects were at risk for AFib and had experienced symptoms..." suggests prospective data collection.

• ECG Function (on-demand):

  • No new clinical, human factors, or ECG database tests were conducted as the function was unchanged from the K201168 clearance. Therefore, a new test set was not used for this specific clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• IHRN Clinical Validation:
  • Subject-level ground truth: "clinician-adjudicated and cardiologist-reviewed patch ECG data." The exact number of clinicians/cardiologists for this overarching adjudication is not specified, but it implies multiple experts.
  • Tachogram-level ground truth: "Two board-certified cardiologists reviewed each reference ECG for annotation with a third cardiologist serving as tie-breaker."
  • Qualifications: "Board-certified cardiologists."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Tachogram-level ground truth: 2+1 (Two board-certified cardiologists reviewed, with a third serving as a tie-breaker).
• Subject-level ground truth: Not explicitly stated as a specific numerical method (e.g., 2+1), but referred to as "clinician-adjudicated and cardiologist-reviewed," implying a consensus or expert-driven process.

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:

• No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned or conducted. The study evaluated the device's performance (IHRN feature) against a clinical ground truth, not the improvement of human readers using the device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, the clinical validation study for the Irregular Heart Rhythm Notification (IHRN) feature primarily assesses the standalone performance of the PPG-based algorithm in identifying irregular rhythms and generating notifications. The "subject-level irregular rhythm notification accuracy" and "tachogram-level positive predictive value" are metrics of the algorithm's performance without direct human interpretation being part of the primary output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• IHRN Clinical Validation: Expert consensus using reference ECG patch data reviewed and adjudicated by clinicians and board-certified cardiologists.

8. The sample size for the training set:

• The document does not specify the sample size for the training set. It focuses on the validation study.

9. How the ground truth for the training set was established:

• The document does not specify how the ground truth for the training set (if any) was established. It only details the ground truth establishment for the test/validation set.

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The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

The Samsung ECG Monitor Application consists of a pair of mobile medical apps: one on a compatible Samsung wearable and the other on a compatible Samsung phone. The compatible Samsung wearable application captures bioelectrical signals from the user and generates single lead ECG signals, calculates average heart rate and classifies the rhythm. The wearable application securely transmits the obtained data to the phone application on the paired phone device. The phone application shows the ECG measurement history and generates the PDF file for the received ECG signals which can be shared by the user.

The Samsung ECG Monitor Application was proven to be non-inferior to the predicate (Apple ECG App, DEN180044) in terms of rhythm classification accuracy and ECG signal quality sufficiency.

Here's the breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: 544 subjects.
  • 268 AFib patients
  • 261 Sinus Rhythm (SR) patients
  • 15 with other arrhythmias
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Samsung Electronics Co., Ltd in Korea. The study structure implies prospectively collected data for this clinical validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Unspecified number of cardiologists and three blinded, independent ECG technicians.
• Qualifications of Experts:
  • Cardiologists: Used for comparing the ECG App algorithm detection of AFib and SR to 12-lead ECG reference strips, and for interpreting the ECG Monitor App strips. No specific experience level provided.
  • ECG Technicians: Three blinded, independent ECG technicians were used for fiducial point annotation. No specific experience level provided.

4. Adjudication method for the test set

• For rhythm classification, the ground truth was established by cardiologists' read of 12-lead ECG reference strips. This implies a consensus or authoritative read by these experts.
• For signal quality interpretability and concordance, cardiologists' interpretation served as the reference.
• For fiducial point annotation, three blinded, independent ECG technicians marked the points, implying their individual annotations were compared against the reference or potentially against each other for a form of consensus, though this is not explicitly detailed.

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

The document describes a clinical study where the algorithm's performance (Samsung ECG Monitor App) was compared to a reference standard (cardiologist-read 12-lead ECG), and also against a predicate device (Apple ECG App). It does not describe an MRMC comparative effectiveness study evaluating how human readers improve with AI vs without AI assistance. The focus was on the algorithm's standalone performance compared to expert ground truth and its non-inferiority to an existing cleared device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was done. The clinical study directly evaluated the Samsung ECG Monitor App algorithm's performance in detecting AFib and Sinus Rhythm against a cardiologist-read 12-lead ECG reference strip. The reported sensitivity, specificity, and inconclusive rates are for the algorithm's performance alone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used was expert consensus / expert interpretation from:

• Cardiologists (for rhythm classification based on 12-lead ECG reference strips and for interpretability and concordance studies).
• Blinded, independent ECG technicians (for fiducial point annotation).

8. The sample size for the training set

The document does not specify the sample size for the training set. It only details the clinical validation study (test set).

9. How the ground truth for the training set was established

The document does not provide information on how the ground truth for the training set was established, as it focuses solely on the clinical validation (test set) and device performance evaluation.

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