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Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.

Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.

The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.

The Verily Numetric Retinal Camera takes images of the fundus in the following manner:

Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.

Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.

Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.

The Verily Numetric Retinal Camera has the following acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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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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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 Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wrist watch.

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 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 realtime 60-second ECG measurement. The patient is able to capture an ECG rhythm on-demand by navigation to the ECG menu, in response to a daily ECG reminder, or 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 wave form. 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 document describes the Study Watch with Irregular Pulse Monitor, focusing on its ability to detect irregular pulses, particularly atrial fibrillation (AF). The performance data presented primarily relates to the Irregular Pulse Monitor algorithm, which uses photoplethysmogram (PPG) data as input.

Here's a breakdown of the acceptance criteria and study findings:

1. Acceptance Criteria and Reported Device Performance

Note: The document does not provide explicit numerical acceptance criteria values, only that the reported performance exceeds them. These reported values are for the PPG-based irregular pulse monitor algorithm, not necessarily the ECG functionality of the watch which is for recording, storing, transfer, and display.

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

• Test Set Sample Size: The document does not explicitly state a numerical sample size for the test set of the clinical study. It mentions the study "collected Study Watch PPG waveform (Test) data in clinic from patients with a history of AF."
• Data Provenance: The document does not specify the country of origin. It indicates the data was collected "in clinic," implying a prospective clinical study specifically for this device's performance validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document states that "contemporaneous Holter ECG (Reference) data" was used as "ground truth." It does not mention the use of human experts to establish this ground truth for the test set. Holter ECG data is considered an objective gold standard for rhythm analysis.

4. Adjudication Method for the Test Set

• The document implies that the ground truth was established by "contemporaneous Holter ECG (Reference) data," which would not require a human adjudication method in the traditional sense (e.g., 2+1, 3+1). The Holter ECG itself serves as the reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The document does not describe an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The study focuses purely on the standalone performance of the irregular pulse monitor algorithm against a clinical reference standard (Holter ECG).

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was done. The reported sensitivity and specificity values of 85% and 96%, respectively, are for the "PPG-based Irregular Pulse Monitor algorithm" operating on the Study Watch PPG data, with Holter ECG as the ground truth. This indicates algorithm-only performance.

7. Type of Ground Truth Used

• The ground truth used for the clinical study was contemporaneous Holter ECG data. This is a clinical gold standard for continuous heart rhythm monitoring.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size used for the training set of the algorithm.

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. Given the nature of a machine learning algorithm for pulse monitoring, it's highly probable that ground truth for training data would also have been established using reference ECGs or similar clinical gold standards.

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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:

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