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510(k) Data Aggregation
(122 days)
Samsung ECG App v 1.3 (ECG)
The Samsung ECG app with IHRN is an over-the-counter (OTC) software-only, 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 user is still and analyze 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 sinus rhythm. AFib. high heart rate (non-AFib), or AFib with high heart rate 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 output without consultation of a qualified healthcare professional.
The Samsung ECG App v1.3 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 cardiac 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. 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.
Acceptance Criteria and Device Performance for Samsung ECG App v1.3
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Reference Device: Apple ECG 2.0 App K201525) | Reported Device Performance (Samsung ECG App v1.3) |
|---|---|---|
| Heart Rate 50-150 BPM | ||
| AFib Sensitivity | 98.5% (95% CI 97.3%, 99.6%) | 96.0% (95% CI 94.0%, 97.8%) |
| Sinus Rhythm Specificity | 99.3% (95% CI 98.4%, 100%) | 98.7% (95% CI 94.0%, 97.8%) |
| Heart Rate 100-150 BPM | ||
| AFib Sensitivity | 90.7% (95% CI 86.7%, 94.6%) | 93.6% (95% CI 88.5%, 97.5%) |
| Sinus Rhythm Specificity | 83% (95% CI 77.8%, 88%) | 96.3% (95% CI 93.5%, 98.9%) |
| Visually Interpretable Waveforms | Not explicitly stated for reference device, but implied by "sufficient" signal quality | 98.7% of cases |
| Accuracy of Key Intervals (RR, PR, QRS) and R-wave amplitude | Not explicitly stated for reference device, but implied by "sufficient" signal quality | Accurately measured when compared against standard Lead I ECG |
Note: The reported performance for Samsung ECG App v1.3's "Sinus rhythm (HR 50-150 BPM)" and "AFib (HR 50-150 BPM)" is presented with the same 95% CI: (94.0%, 97.8%). This might be a transcription error in the document, as specificity and sensitivity for different conditions would typically have distinct confidence intervals. Assuming independent calculations, these values are presented as they appear in the source.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1,013 subjects. These subjects contributed to 453 AFib recordings (heart rate 50 to 150 BPM) and 691 Sinus rhythm recordings (heart rate 50 to 150 BPM) for the primary endpoint analysis.
- Data Provenance: The study was a multi-center study, implying data from multiple locations, likely within the US given the FDA submission context and the racial demographics provided (predominantly Caucasian). The study was likely prospective as it involved recruiting subjects and collecting data for validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the "number of experts" or their specific "qualifications" used to establish the ground truth for the test set. It mentions "Clinical Validation showing comparable clinical performance...compared to the reference device" and that the "ECG function accurately classified...compared against the standard Lead I ECG," implying that comparison was made to physician-adjudicated or expertly interpreted ECGs, but the details of the ground truth establishment are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used for establishing the ground truth for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being done, or any effect size of how much human readers improve with AI vs without AI assistance. The study focuses on the standalone performance of the device's ECG rhythm classification compared to a reference device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was conducted. The "Clinical Validation" section details the performance of the "ECG rhythm classification of the Samsung ECG App v1.3" in terms of sensitivity and specificity against a clinical ground truth, without explicit human-in-the-loop interaction for the classification task itself. The device "accurately classified" recordings.
7. Type of Ground Truth Used
The ground truth used was clinical diagnosis based on "446 subjects diagnosed with AFib, 536 subjects without AFib, and 31 subjects diagnosed with another type of irregular rhythm." The performance was evaluated by comparing the device's classifications against "standard Lead I ECG" interpretation, implying expert consensus (from qualified healthcare professionals interpreting the standard ECGs) or clinical diagnosis as the ground truth.
8. 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 provide information on how the ground truth for the training set was established.
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