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The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients (22 years and older) who have been diagnosed with, or are susceptible to developing, atrial fibrillation enabling them to monitor and record their heart rhythms. Study Watch is also intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms.

The Study Watch is intended for prescription use only.

The Study Watch with Irregular Pulse Monitor is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. The Study Watch with Irregular Pulse Monitor is intended to notify the user in the event of an irregular pulse, such as atrial fibrillation (AF), and recommend acquisition of an ECG. The device utilizes a band and proprietary watch that incorporates two dedicated sensing electrodes to obtain a single-channel ECG measurement. In practice, a healthcare professional (HCP) may prescribe the Study Watch with Irregular Pulse Monitor to a patient and recommend the capture and transmission of one or more ECG rhythms on a daily basis for analysis by the HCP. The patient uses prompts provided on the graphical user interface (GUI) of the watch to collect a real-time 45-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, upon receipt of an irregular pulse notification. While an animated ECG waveform is briefly displayed on the GUI of the watch, the patient will not have direct access to the collected waveform. Using the provided charging dock (Cradle) and Verily's Study Hub or Watch App, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. Additionally, data may be securely transferred to interoperable devices for further analysis. The web portal is solely intended for use by the HCP to view time-stamped ECG waveforms collected by the patient and does not include any analysis features. Collectively, the Study Watch consists of the wearable watch and band, the Study Hub or Watch app (used to transfer data from the watch to the cloud), a Cradle, and the web portal.

Below is a detailed description of the acceptance criteria and the study proving the device meets these criteria, based on the provided document.

Device Name: Study Watch with Irregular Pulse Monitor

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the algorithm "exceeds the pre-specified per-interval performance thresholds for sensitivity and specificity," but the exact numerical thresholds are not provided within the given text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "thousands of ECG data collected from iRhythm Technologies' Zio devices" for algorithm training but does not explicitly state the sample size for the validation (test) set. However, it describes the "Study Watch AF Detection At Home (NCT04546763) data" as consisting of "free-living, multi-day PPG recordings obtained from the Study Watch, along with ECG-based rhythm labels obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously."
• Data Provenance: The study was conducted in the USA, with regional demographics provided: Midwest (8%), Mountain (32%), West (32%), Northeast (14%), South (13%). The data was collected prospectively in a "free-living (home use) setting."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: The algorithm was trained using ECG data that had undergone "Certified Cardiographic Technician (CCT) review." It can be inferred that similar qualified personnel were involved in establishing the ground truth for the validation set, as the reference standard (Zio XT Patches) typically requires expert interpretation.

4. Adjudication Method for the Test Set

• The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It only mentions that ECG-based rhythm labels were "obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously" and that the training data underwent "Certified Cardiographic Technician (CCT) review."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This study focused on the standalone performance of the irregular pulse monitoring algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance study was done. The described "Clinical Performance Data" section focuses solely on the algorithm's performance (sensitivity and specificity) in detecting irregular pulses based on PPG data, using a reference ECG as ground truth, without human-in-the-loop evaluation.

7. The Type of Ground Truth Used

• Clinical Ground Truth: The ground truth for validation was established using ECG-based rhythm labels obtained from reference iRhythm Technologies Zio XT Patches worn simultaneously with the Study Watch. This is a robust clinical ground truth for cardiac rhythm analysis.

8. The Sample Size for the Training Set

• The algorithm was trained using "thousands of ECG data collected from iRhythm Technologies' Zio devices." A specific number is not provided beyond "thousands."

9. How the Ground Truth for the Training Set Was Established

• The ground truth for the training set was established through "ECG data collected from iRhythm Technologies' Zio devices, which have undergone Certified Cardiographic Technician (CCT) review." This indicates human expert review by qualified professionals.

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