(107 days)
KardiaMobile 6L is intended to record, store and two-channel electrocardiogram (ECG) rhythms. In single channel mode, KardiaMobile 6L can record Lead-I. In two channel mode, KardiaMobile 6L can record Lead-I and Lead-II simultaneously and derive Lead-III and unipolar limb leads aVE. KardiaMobile 6L 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. KardiaMobile 6L 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.
KardiaMobile 6L 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. KardiaMobile 6L provides output of one or six ECG leads, including Lead I, Lead II, Lead III, aVL, aVR and aVF. The device utilizes the computing power of iOS-based or Android-based devices (referred to as "Mobile Computing Platforms" (MCP) within this submission) to obtain and analyze ECG signals. KardiaMobile 6L consists of KardiaMobile 6L Hardware (portable small wireless hardware with electrodes) and the Kardia App, which is installed on an MCP (i.e., iOS or Android devices). KardiaMobile 6L hardware uses Bluetooth to transmit the ECG signal from the electrodes to the Kardia App on the MCP. KardiaMobile 6L displays thus record their ECG and additionally provides ECG analysis using the KardiaAI (K181823, K201985) ECG analysis suite, which includes the determinations of Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified. The device is intended to be used by patients with known or suspected heart conditions and health conscious individuals as well as by healthcare professionals (HCPs) who want to remotely monitor their patient's heart health. Patients can forward the recorded ECG to their HCP, who can review the ECG for rhythm and to measure the QT interval. The device is available for Over-the-Counter (OTC) purchase and for purchase with a prescription. The Kardia App is also comes in an alternate variant, called the KardiaStation App that is exclusively used within hospitals and clinics; this app is identical to the Kardia App with the exception of incorporating patient administration workflows.
Here's a summary of the acceptance criteria and study details based on the provided text, focusing on the expanded use case of QT interval measurement for healthcare professionals:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document specifically addresses the expanded use case for healthcare professionals to measure the QT interval. It compares the KardiaMobile 6L's ability to measure QT intervals against a gold standard 12-lead diagnostic ECG device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| QT interval measured by KardiaMobile 6L is equivalent to a gold-standard 12-lead diagnostic ECG device. | The comparative statistical analysis of this assessment determined that the QT interval measured using the subject device is equivalent to the interval measured from a commercial gold-standard diagnostic 12-lead ECG. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 313 subjects.
- Data Provenance: Not explicitly stated regarding country of origin, but the study design suggests prospective data collection as ECG recordings were "taken comparison" and included "both healthy volunteers and patients suspected of long QT syndrome or other genetic heart disease."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document states that a "core lab used to provide precise QT measurements for Thorough QT studies was utilized to measure the QT and heart-rate corrected QTc in each ECGs."
- Number of Experts: Not specified.
- Qualifications of Experts: Implied expertise in QT measurement for Thorough QT studies, indicating highly specialized cardiac electrophysiology expertise.
4. Adjudication Method for the Test Set
- The document mentions that the core lab measured QT and QTc "in a randomized and blinded order, using standard measurement techniques." This suggests a robust, independent assessment, but a specific "adjudication method" (e.g., 2+1, 3+1) is not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly described for the expanded QT interval measurement use. The study focused on the equivalence of QT measurements from the device compared to a gold standard, not on the improvement of human readers with AI assistance. The "human readers" in this context were the core lab experts establishing ground truth, not users of the device whose performance was being evaluated for improvement with AI.
6. Standalone (Algorithm Only) Performance
- No, an explicit standalone (algorithm only without human-in-the-loop performance) study for QT interval measurement was not described. The study validated that "a healthcare professional can review and measure the QT interval reliably using an ECG recorded using KardiaMobile 6L." While the device records the ECG, the measurement itself is performed by a human expert/core lab. The device's role here is data acquisition for human interpretation.
- It's important to note that the KardiaAI platform (K181823, K201985) does run algorithms for detecting Atrial Fibrillation, Normal Sinus Rhythm, Bradycardia, Tachycardia, or Unclassified rhythms, and these would have had standalone performance studies in their original clearances. However, for the expanded QT interval measurement claim, the study focuses on the reliability of the ECG recording for human measurement.
7. Type of Ground Truth Used
- Expert Consensus / Highly Specialized Core Lab Measurement: The QT and heart-rate corrected QTc measurements were performed by a "core lab used to provide precise QT measurements for Thorough QT studies." This represents a high-level, specialized form of expert consensus and measurement standard.
8. Sample Size for the Training Set
- Not provided. The document focuses on the clinical validation study for the QT interval measurement claim, which is a test set evaluation. Information about the training set for any underlying algorithms is not included in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not provided. As the training set size is not mentioned, neither is the method for establishing its ground truth.
§ 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).