Search Results

The KardiaMobile Card System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile Card System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAl platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and others. The KardiaMobile Card 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 AliveCor KardiaMobile Card System is a single-channel ambulatory electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms in an ambulatory setting. The device utilizes the computing power of Apple iOS- and Google Android-based smartphones to obtain and analyze single-channel ECGs. These smartphones are termed Mobile Computing Platforms (MCPs). The device consists of the hardware (that has the electrodes), and the Kardia phone app (installed on an MCP). The same software is implemented in the iOS and Android MCP. In either configuration, the same hardware is used to sense the ECG. The KardiaMobile Card Hardware transmits the ECG signal from the electrode 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 provided text, K211668, is an FDA 510(k) clearance letter for the AliveCor KardiaMobile Card System. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not include detailed information regarding clinical study data to demonstrate the device meets acceptance criteria for the KardiaAI platform's specific ECG analysis functionalities (detecting normal sinus rhythm, atrial fibrillation, bradycardia, and others).

The "PERFORMANCE DATA" section primarily describes bench testing related to the hardware modifications (change in data transmission method from ultrasonic acoustics to BLE, and change in hardware material). It lists various IEC and ISO standards for ECG acquisition, transmission, biocompatibility, electrical safety, and electromagnetic compatibility.

Therefore, I cannot provide a complete answer to your request based on the provided text, as it lacks the specific clinical study data (acceptance criteria, reported performance, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training set details) related to the diagnostic performance of the KardiaAI platform itself.

The document states: "No modifications were made to the Kardia app software's clinical functionalities with respect to ECG acquisition, display, and analysis because of this change since its prior clearance under K191406, K182396 and K201985." This implies that the clinical performance evaluation of the KardiaAI platform was conducted during the clearance of the predicate devices (K191406, K182396, K201985), and this 510(k) focuses on the substantial equivalence of the new hardware (KardiaMobile Card) to those previously cleared systems.

To answer your question fully, information from the 510(k) submissions for K191406, K182396, and/or K201985 would be required, as they would contain the detailed clinical performance studies for the KardiaAI platform.

Based only on the provided K211668 document, I can infer the following about what is not present:

• No acceptance criteria for diagnostic performance: The document does not state specific accuracy, sensitivity, or specificity thresholds for detecting cardiac rhythms.
• No reported device performance for diagnostic accuracy: There are no tables or summaries of clinical performance metrics for the KardiaAI algorithms.
• No sample sizes for a clinical test set (for diagnostic performance): The document only mentions bench testing for hardware.
• No details on data provenance (for diagnostic performance): No information on origin, retrospective/prospective nature of a clinical test set.
• No information on experts for ground truth (for diagnostic performance): No details on number, qualifications, or adjudication methods for ECG interpretations.
• No MRMC study details: The document does not describe any human reader studies.
• No standalone (algorithm-only) performance data (for diagnostic performance): The focus is on hardware changes, not re-evaluation of the AI algorithms.
• No information on training set size or ground truth establishment for the AI algorithms.

In summary, the provided document K211668 does not contain the information requested about the acceptance criteria and the study that proves the device meets diagnostic performance acceptance criteria for the KardiaAI platform. It only addresses the substantial equivalence of the hardware changes for the KardiaMobile Card.

Ask a specific question about this device