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The Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) is indicated as follows:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The device includes the Atrial Fibrillation Detection Feature analyzes pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of atrial fibrillation (AFib) and provides a notification on the display screen to the user. This feature is intended to be used for home screening for the possibility of AFib.

The Atrial Fibrillation Detection Feature is not intended to provide a notification on every episode of AFib and the absence of detection is not intended to indicate the absence of atrial fibrillation. The feature is not intended to replace traditional methods of diagnosis or treatment or to be used in the management of patients with known AFib.

The device is intended for over-the-counter (OTC) use in the home environment. The device is intended for use in adults (22 years or older); it has not been tested for and is not intended for use in pregnant women or people with implanted pacemakers or defibrillators.

The Omron Blood Pressure Monitor with AFib Detection Feature is an OTC, at home use, upper arm blood pressure monitor. The device consists of a monitor and an arm cuff designed to be used on the upper arm. It is battery powered and can optionally be connected to an AC adapter. The proposed device measures blood pressure (systolic [SYS] and diastolic [DIA]) and pulse rate (PR), detects the presence of irregular heartbeats, and can also detect the possible presence of AFib by analyzing pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of AFib and provides a notification on the display screen to the user.

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

Acceptance Criteria and Device Performance

Note: The acceptance criteria were explicitly stated as "statistically significant to the target goal (85%)" for both sensitivity and specificity. The reported results for both devices demonstrate values well above 85% with highly significant p-values, indicating that the criteria were met.

Study Details

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

• Total Subjects Screened: 654
• Total Subjects Enrolled: 573
• Modified Intent-To-Treat (mITT) Population: 559 subjects
  • 267 subjects with a known diagnosis of AFib (AFib cohort)
  • 292 subjects without a known diagnosis of AFib (non-AFib cohort)
• Data Provenance: The study was a prospective, non-randomized, multi-center study. The specific country of origin is not explicitly stated, but it was conducted at 5 investigational sites. No mention of retrospective data collection.

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

• Number of Experts: Three independent board-certified cardiologists.
• Qualifications: Board-certified cardiologists. (Specific years of experience are not mentioned).

4. Adjudication Method for the Test Set:

• Method: If the readers disagreed on the diagnosis (AFib vs. non-AFib based on interpretable ECGs), the final interpretation was determined by the simple majority rule.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. The study evaluated the standalone performance of the device's AFib detection feature against a ground truth established by expert-adjudicated ECGs.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Yes, the study assessed the AFib classification performance of the OMRON BPMs with the AFib Detection Feature by comparing the device's output data to the ground truth established by physician-adjudicated 12-lead ECGs. This is a standalone assessment of the device's algorithmic performance.

7. The Type of Ground Truth Used:

• Expert Consensus: Ground truth for AFib identification was established from ECG adjudication performed by multiple independent expert adjudicators (three independent board-certified cardiologists). They classified ECG readings into "AFib is observed (AFib)" or "AFib is not observed (non-AFib)" after determining interpretability.

8. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set. The provided information focuses solely on the clinical validation study (test set). Details on the development or training of the algorithm are not included under the "Clinical Information" section.

9. How the Ground Truth for the Training Set was Established:

• Since the training set sample size is not provided, the method for establishing its ground truth is also not described in this document. The document pertains to the clinical validation of the pre-trained device.

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