(282 days)
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.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).