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The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a twochannel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVF, aVL. The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician).

The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.

The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.

The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth and Wi-Fi capabilities that connects to a companion mobile application. The Withings Scan Monitor 2.0 is intended to create, record, store, transfer and display lead-III of a two-channel electrocardiogram (ECG).

When a user stands on the scale and holds the handle attached to it, a 30 second ECG recording begins. The Withings Scan Monitor 2.0 software analyzes data collected by the electrical sensors present on the scale to generate lead-III simultaneously and derive lead-I and leads aVR, aVF and aVL, calculate heart rate, and provide a rhythm classification to the user that is displayed on the scale. The companion application is intended to display, store, manage and share data.

The Withings Scan Monitor 2.0 classifies ECG signals as follows:

• Normal Sinus Rhythm
• Atrial Fibrillation
• Inconclusive
• Noise - Inconclusive

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document defines acceptance criteria primarily through the clinical study results and comparison to the predicate device.

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

• Test Set 1: 137 participants
• Test Set 2: 262 participants
• Clinical Study Test Set (Validation): 274 patients (40 excluded from analysis, resulting in 234 analyzed patients for the confusion matrix).
• Data Provenance:
  • Algorithm Test Data Sets (1 & 2): Not explicitly stated if retrospective or prospective, or country of origin, however, they are summarized with demographic characteristics.
  • Clinical Study: Prospective, cross-sectional, diagnostic, multicentric, open-label study. No specific country mentioned, but typical for regulatory submissions, it would be a clinical site (or sites) adhering to relevant regulations.

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

• Number of experts: Not explicitly stated as a specific count, but the document mentions that a "12-lead Reference ECG signals reviewed by cardiologists" was used as ground truth. This implies an expert review process by qualified cardiologists.
• Qualifications of experts: "Cardiologists." No further details on years of experience or sub-specialty are provided.

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

• The document states "12-lead Reference ECG signals reviewed by cardiologists" was used as the ground truth. It does not explicitly mention a specific adjudication method like 2+1 or 3+1. It suggests a single expert review or an implicit consensus process among cardiologists without detailing the mechanism.

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, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with AI assistance versus without AI assistance was not explicitly described in the provided text. The study primarily focuses on the standalone performance of the device's rhythm classification algorithm against expert-labeled 12-lead ECGs.

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

• Yes, a standalone performance evaluation of the algorithm was done. The clinical study directly assesses the performance of the "rhythm classification algorithm ECG-SW1 running on the subject device Withings Scan Monitor 2.0" against the cardiologist-reviewed 12-lead ECGs. The confusion matrix and sensitivity/specificity calculations are for the device's algorithm output.

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

• The ground truth for the clinical study was established by expert review of 12-lead reference ECG signals by cardiologists.

8. The sample size for the training set

• The document states, "Publicly available datasets were utilized for the training datasets consist of several smaller datasets." It does not specify the exact sample size or number of ECG recordings used for the training set.

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

• The ground truth for the training set was established using "Publicly available datasets." The specific methods for how the ground truth was originally established for these publicly available datasets are not detailed in this document. It implicitly relies on the quality and labeling of those common, openly accessible datasets.

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