(161 days)
The Triangle System is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, the Triangle System can record Lead-I. In two channel mode, the Triangle System can record Lead-I and Lead-II simultaneously and derive Lead-II and unipolar limb leads aVR, aVF and aVL. The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAl platform including detecting the presence of normal sinus rhythm, atral fibrillation, bradycardia, and others. The Triangle System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.
The Triangle System is a trans-telephonic (transmission by smartphone) electrocardiogram (ECG) event recorder that records, stores, transfers, and analyzes single-channel or two-channel ECG rhythm recordings. The Triangle System provides output of one or six ECG leads by recording Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVR, aVF, and aVL for identifying cardiac arrhythmias. The device utilizes the computing power of iOS-based or Android-based smartphones (referred to as "Mobile Computing Platforms" (MCP) within this submission) to obtain and analyze ECG signals. The device consists of the Triangle Hardware (portable small wireless hardware with electrodes) and the Kardia app, which is installed on an MCP (i.e., iPhone or Android phone). The Triangle System is a new addition to AliveCor's ambulatory ECG devices that are intended to be used by lay users to record their ECG and obtain ECG analysis of Atrial Fibrillation. Normal Sinus Rhythm, Bradycardia, Tachycardia, or unclassified file. The Triangle System hardware transmits the ECG signal from the electrodes to the Kardia phone app on the MCP to be analyzed and presented to the user. All ECGs are synced with the user's account. The device is available for Over-the-Counter (OTC) purchase and for purchase with clinician prescription.
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or target format for the qualitative and quantitative analyses. Instead, it describes the results of the assessments that demonstrate equivalence.
| Acceptance Criteria (Implied/Derived from Results) | Reported Device Performance (Triangle System) |
|---|---|
| Qualitative Equivalence for Cardiac Arrhythmia Assessment: Diagnostic equivalence with a gold standard 12-lead ECG device. | All paired recordings (100%, n=44 subjects) were deemed equivalent for assessing cardiac arrhythmias by both electrophysiologists when comparing 6-lead ECG rhythm strips from the Triangle device to corresponding leads from the reference standard 12-lead ECG device. |
| Quantitative Equivalence (Lead I & II): High beat cross-correlation with a gold standard 12-lead ECG device. | Minimum beat cross-correlation of 0.96 for Lead I and Lead II compared to the corresponding lead of the 12-lead ECG. |
| Quantitative Equivalence (All 6 Limb Leads): Low RMS error with a gold standard 12-lead ECG device. | Maximum RMS error of 47 uV for all 6 limb leads compared to the corresponding lead of the 12-lead ECG. |
| Safety: No adverse events during clinical study. | No adverse events were observed during the clinical study. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: 44 subjects
- Data Provenance: The text states, "Overall, 44 subjects participated in the study, that included nearly equal numbers of healthy volunteers and arrhythmia patients." It does not explicitly state the country of origin or if the study was prospective or retrospective, but the clinical study setup (simultaneous ECG recordings) strongly suggests a prospective design. The subjects appear to be a mix of healthy individuals and those with arrhythmias.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Two
- Qualifications of Experts: "Two board-certified electrophysiologists."
4. Adjudication Method for the Test Set:
- Adjudication Method: The text states, "two board-certified electrophysiologists compared 6-lead ECG rhythm strips acquired from the Triangle device and the corresponding leads from the reference standard 12-lead ECG device for diagnostic equivalence." It then concludes, "All paired recordings (100%, n=44 subjects), were deemed equivalent for assessing cardiac arrhythmias by both electrophysiologists." This implies that both experts had to agree for a recording to be deemed equivalent. There is no mention of a tie-breaking third expert, suggesting unanimosity was required for the reported 100% equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No. The study described is a comparison of the device's output to a gold standard, not a comparison of human readers' performance with and without AI assistance. While the device utilizes the KardiaAI platform, this specific clinical study focused on the hardware's ability to record equivalent ECG signals, not the AI's impact on human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was a standalone study done? Yes, to a degree outlined in the "Validation of KardiaAI integration" under non-clinical testing. However, the specific clinical study described does involve human experts (electrophysiologists) for the qualitative assessment, indicating a human-in-the-loop component for validation of the output. The quantitative assessment is purely algorithmic comparison (cross-correlation and RMS error). The statement, "The Triangle System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others," suggests the AI provides its own analysis which would be a standalone capability, but the clinical study discussed here is primarily about the signal equivalence of the hardware. The KardiaAI itself would have had standalone performance studies, but those are not detailed here for this K183319 submission.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for the clinical study was established using a gold standard 12-lead ECG device (for both qualitative and quantitative comparison of ECG signals) and the expert consensus of two board-certified electrophysiologists (for qualitative diagnostic equivalence).
8. Sample Size for the Training Set:
- The document does not provide information regarding the sample size for the training set. The clinical study described involves performance validation of the Triangle System hardware, not training of the KardiaAI algorithms.
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 of the KardiaAI platform 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).