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510(k) Data Aggregation
(269 days)
FibriCheck
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance in line with the predicate device (K173872 FibriCheck) | Capable of irregular rhythm detection accuracy in line with the predicate device. Performance metrics did not raise concerns regarding safety or effectiveness. |
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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(282 days)
FibriCheck
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 medical device software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation. It makes use of optical sensing from a mobile device to collect photoplethysmogram data (PPG data). The recordings can be shared optionally with a physician or monitoring service.
The FibriCheck web application, an online tool, has the sole intention to display data. Professional users can use the web application for managing patients and reviewing FibriCheck data.
Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA submission:
Device: FibriCheck (Atrial Fibrillation Monitor)
Intended Use: Self-testing by patients diagnosed with, or susceptible to, atrial fibrillation to monitor and record heart rhythms intermittently.
1. Acceptance Criteria and Reported Device Performance
The submission implicitly defines acceptance criteria through its clinical performance comparison. While explicit numerical thresholds for sensitivity/specificity/PPV/NPV/accuracy are not stated as "acceptance criteria," the comparison aims to demonstrate that FibriCheck's diagnostic performance is comparable to a legally marketed reference device (Kardia/AliveCor). The key performance metrics are presented as actual results.
| Performance Metric | Acceptance Criteria (Implicit - Comparable to Kardia) | FibriCheck Reported Performance | Kardia Reported Performance |
|---|---|---|---|
| Sensitivity | Comparable to Kardia | 95.60% | 94.09% |
| Specificity | Comparable to Kardia | 96.55% | 97.47% |
| Positive Predictive Value (PPV) | Comparable to Kardia | 95.60% | 91.59% |
| Negative Predictive Value (NPV) | Comparable to Kardia | 96.55% | 89.53% |
| Accuracy | Comparable to Kardia | 96.14% | 95.09% |
Note: The submission states, "This means that both methods have comparable diagnostic results," implying that meeting or exceeding Kardia's performance was the implicit acceptance goal.
2. Sample Size and Data Provenance
- Test Set Sample Size: 223 subjects
- Data Provenance: The document does not explicitly state the country of origin or if the study was retrospective or prospective. It is a "clinical performance study" where subjects participated, which typically implies a prospective design.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. It mentions that the devices were "compared towards a gold-standard 12-lead ECG device." This implies that the interpretation of the 12-lead ECG (which serves as the "gold standard") would have been done by qualified medical professionals (e.g., cardiologists or electrophysiologists), but specifics are not provided in this excerpt.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly described in the provided text. The reliance on a "gold-standard 12-lead ECG device" suggests that the 12-lead ECG readings were used as the definitive diagnosis, but how those readings themselves were confirmed (e.g., single expert, consensus of multiple experts) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described. The study compared the device's performance (FibriCheck vs. Kardia) against a gold standard (12-lead ECG), not the improvement of human readers with or without AI assistance. This was a standalone performance comparison.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done for FibriCheck. The provided performance metrics (sensitivity, specificity, PPV, NPV, accuracy) for FibriCheck are its algorithm-only performance when compared against the 12-lead ECG ground truth.
7. Type of Ground Truth Used
The type of ground truth used was gold-standard 12-lead ECG device. This is a clinical diagnostic standard for cardiac rhythm analysis.
8. Sample Size for the Training Set
The document does not provide the sample size for the training set used for FibriCheck's algorithm development. The performance data presented refers to the test set performance.
9. How 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.
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