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FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

FibriCheck is a medical device software that can be used to determine heart rhythm conditions, with a primary focus on the detection of atrial fibrillation.

The FibriCheck Mobile Application is a smartphone application for patients intended to record, display, store and transmit photoplethysmography (PG) data. Heart rhythm measurements are performed by placing the fingertip on the camera of a smartphone device. This way, volumetric changes can be detected.

The FibriCheck Portal is a web application for healthcare providers intended to display data that was captured by the FibriCheck Mobile Application. Healthcare providers can use the issue FibriCheck prescriptions, to manage their patients and to consult measurement data.

This document is a 510(k) Pre-market Notification summary for the FibriCheck device. It outlines the device details, its intended use, comparison to a predicate device, and the non-clinical and clinical tests conducted to demonstrate safety and effectiveness.

Here’s a breakdown of the information relevant to acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it states that "The performance metrics are in line with those reported for the predicate device, and did not raise concerns regarding the safety or effectiveness of the subject device." This implies the acceptance criterion was "performance in line with the predicate device," which is K173872, also named FibriCheck.

The document reports the following general performance statement for the clinical validation study:

2. Sample Size and Data Provenance

• Sample Size for Test Set: 252 cardiology patients.
• Data Provenance: The patients were "recruited in-clinic or consulting the cardiac outpatient clinic," implying the data was collected prospectively in a clinical setting. The country of origin is not explicitly stated, but given the applicant's address in Belgium, it's highly probable the study was conducted there.

3. Number of Experts and Qualifications

The document states, "The participants were instructed to record PPG measurements using the subject device which were compared against the gold-standard reference diagnosis." It does not explicitly specify the number of experts used to establish ground truth or their qualifications. However, given the "gold-standard reference diagnosis" in cardiology and the mention of "cardiology patients," it can be inferred that diagnoses were made by qualified medical professionals, likely cardiologists.

4. Adjudication Method

The document does not describe an adjudication method for the test set. It mentions comparison against a "gold-standard reference diagnosis," suggesting a single, definitive ground truth rather than a process requiring adjudication among multiple readers.

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

The document does not mention an MRMC study or any comparative effectiveness study involving human readers with and without AI assistance. The study described focuses on the device's standalone performance against a gold standard.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The clinical validation study directly compared the PPG measurements from the FibriCheck device (acting as the algorithm) against a "gold-standard reference diagnosis." The statement "The participants were instructed to record PPG measurements using the subject device which were compared against the gold-standard reference diagnosis" highlights the device's algorithmic performance.

7. Type of Ground Truth Used

The ground truth used was a "gold-standard reference diagnosis." While the specific nature of this diagnosis (e.g., expert consensus based on ECG, long-term monitoring data, etc.) is not detailed, in cardiology, a "gold-standard reference diagnosis" for atrial fibrillation typically involves a 12-lead electrocardiogram (ECG) or continuous ECG monitoring interpreted by a cardiologist.

8. Sample Size for Training Set

The document does not provide information on the sample size used for the training set. It only describes the clinical validation study (test set).

9. How Ground Truth for Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training process or dataset.

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