Search Results

The Study Watch is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The Study Watch is intended for use by healthcare professionals, adult patients (22 years or older) with known or suspected heart conditions, and health conscious individuals.

The Study Watch is a miniaturized physiological data monitoring device that is intended to record, store, transfer and display single-channel electrocardiogram (ECG) rhythms. 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 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 60-second ECG measurement. 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 device, the ECG measurements are securely transferred to Verily's cloud server and are viewed by the HCP using a web portal. 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 (used to transfer data from the watch to the cloud), a Cradle, and the web portal.

The device in question is the Study Watch, intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of specific acceptance criteria. However, it states that "All tests confirmed that the product met the predetermined acceptance criteria." It also details the clinical performance finding:

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

The document does not explicitly state the sample size for the clinical performance test set, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only generically mentions "clinical performance testing was conducted."

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. It only mentions comparison to an "industry-standard 12-lead ECG device."

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

The document does not specify any adjudication method used for the test set.

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 was not done. The Study Watch, unlike its predicate, does not include any analysis features for detecting conditions like atrial fibrillation or normal sinus rhythm and therefore does not involve AI assistance for human readers in that capacity. Its purpose is to record, store, transfer, and display single-channel ECG rhythms for review by a healthcare professional.

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

Yes, a standalone performance evaluation was done to some extent for the device's core function of ECG recording and display, as indicated by the "Clinical performance testing was conducted to demonstrate that the Study Watch generates data that meets the clinical quality requirements for an accurate ECG waveform display." The quantitative comparison (Bland-Altman analysis) was directly comparing the Study Watch's output to a standard ECG device, implying evaluation of the device's intrinsic data generation capabilities.

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

The ground truth for the clinical performance testing was established by comparing the data generated by the Study Watch to an "industry-standard 12-lead ECG device." This implies the 12-lead ECG device served as the reference standard for accurate ECG waveform measurement, particularly for the inter-beat interval analysis.

8. The sample size for the training set

The document does not specify any sample size for a training set. The Study Watch does not appear to employ an AI algorithm that would typically require a training set in the context of diagnostic interpretation features (as these features are explicitly absent).

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

Not applicable, as no training set for an AI algorithm is mentioned or implied for diagnostic interpretation. The device's primary function is data acquisition and display, not AI-driven analysis of the ECG.

Ask a specific question about this device