(220 days)
The KardiaMobile System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The KardiaMobile 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 (when prescribed or used under the care of a healthcare professional). The KardiaMobile 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 KardiaMobile System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes the computing power of Apple iOS- and Google Android-based smartphones to obtain and analyze single-channel ECG. 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 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 documents describe the KardiaMobile System and its substantial equivalence to a predicate device. However, the specific acceptance criteria for the device's performance related to its AI algorithms (atrial fibrillation, normal sinus rhythm, tachycardia, bradycardia, and noise detection) and the detailed study that proves these criteria are met are NOT explicitly detailed within the provided text.
The document states:
- "The KardiaMobile System... 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..."
- "Available Algorithms: Atrial Fibrillation, Noise Algorithm, Normal Sinus Rhythm, Tachycardia, Bradycardia (implements the same algorithms of the KardiaAI reference device, K181823)"
- "All necessary performance testing was conducted on the KardiaMobile System to support a determination of substantial equivalence to the predicate device. This testing included the following: - validation of KardiaAI integration"
While it confirms that "validation of KardiaAI integration" was part of the testing, it does not provide the specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets for each rhythm detection) or the details of the study (sample size, ground truth establishment, expert qualifications, etc.) for the AI algorithms themselves.
Therefore, for aspects related to the performance of the AI algorithms, the requested information cannot be fully extracted from the provided text. The document focuses more on the substantial equivalence of the overall system (hardware and software integration) to a predicate device, rather than a detailed performance study for the AI algorithms against specific statistical targets.
However, based on the information provided for the overall system's substantial equivalence:
1. Table of acceptance criteria and the reported device performance:
The document does not provide a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) for the rhythm detection algorithms. Instead, the acceptance is based on the system demonstrating substantial equivalence to the predicate device (AliveCor Heart Monitor K142672) and the reference device's (KardiaAI K181823) algorithms, and meeting established specifications through nonclinical testing.
Reported Device Performance (General):
- Validation of KardiaAI integration: Performed.
- Verification of the device's specification: Performed.
- Testing to software level of concern requirements: Performed.
- Compliance with standards: ISO 10993-1:2009, IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-11:2015, IEC 60601-2-47:2012.
- Conclusion: "The collective results of the performance testing demonstrate that the KardiaMobile System meets the established specifications and complies with the aforementioned standards." and "The evaluation and testing results showed that differences between the subject and predicate device do not raise different questions of safety or effectiveness."
The following information applies to the overall system's validation and substantial equivalence as described, but not specifically to the detailed performance of the AI algorithms against quantifiable targets, which is not provided in the text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided documents. The text mentions "validation of KardiaAI integration" and "verification of the device's specification" but does not detail the size of the dataset used for these tests.
- Data Provenance: Not specified. It is not mentioned if the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided documents. The text does not detail the process of establishing ground truth for any test sets related to the AI algorithms.
4. Adjudication method for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance is not described in the provided documents. The submission focuses on the substantial equivalence of the device, including its AI algorithms, rather than a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the algorithms were evaluated independently as part of the "KardiaAI integration validation" and reference to "KardiaAI K181823". However, the specific details of such a standalone study (e.g., metrics, test set, ground truth) are not provided for the algorithms themselves. The overall device is described as having "output of ECG analysis from AliveCor's KardiaAI platform," suggesting that the algorithms perform analysis independently before being displayed to the user.
7. The type of ground truth used:
- Not specified in the provided documents.
8. The sample size for the training set:
- Not specified in the provided documents.
9. How the ground truth for the training set was established:
- Not specified in the provided documents.
§ 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).