(126 days)
The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals.
The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) single-lead ECG (electrocardiogram) event recorders. The device utilizes the processing power of a mobile computing platform (MCP) while reducing the complexity of the electronics hardware associated with data acquisition and transmission. The device is placed on the chest or held by the user's hands to provide a single-channel ECG rhythm strip. Similar to other mobile ECG devices, the AliveCor Heart Monitor uses a proprietary method of data transmission using acoustic waves to communicate with the MCP where the waveform is stored, displayed, and analyzed for the presence of atrial fibrillation.
The provided text describes the AliveCor Heart Monitor and its 510(k) premarket notification (K140933) to the FDA. The submission focuses on establishing substantial equivalence to predicate devices, particularly regarding its ability to record, store, transfer, and display single-channel ECG rhythms, and detect the presence of atrial fibrillation (AF).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly provide a table of acceptance criteria with specific quantitative thresholds. However, it states that "The AF algorithm was tested in accordance with AAMI/ANSI EC57" and that "The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications necessary for consistent performance for its intended use."
Based on the context, the primary performance criterion for the atrial fibrillation (AF) algorithm is its ability to accurately detect AF. While a table isn't present, the implied acceptance criterion is adherence to AAMI/ANSI EC57 standards for AF algorithm validation. The reported device performance is that it meets these established specifications.
Implied Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Atrial Fibrillation (AF) Detection Algorithm | Adherence to AAMI/ANSI EC57 standards for AF algorithm validation. | The AF algorithm was tested in accordance with AAMI/ANSI EC57, and the collective results demonstrate it meets the established specifications. |
| ECG Recording, Storage, and Transfer | Consistent performance for intended use. | Non-clinical testing results demonstrate that the device meets established specifications for consistent performance for its intended use. |
Study Details Proving Acceptance Criteria
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "ECGs that were previously recorded using the AliveCor Heart Monitor." It doesn't specify the number of ECGs used for validation.
- Data Provenance: The data used for validation consisted of "ECGs that were previously recorded using the AliveCor Heart Monitor." The country of origin is not specified, but it implies a dataset collected by AliveCor itself. The data is retrospective, as it refers to "previously recorded" ECGs.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The text mentions "labeled by cardiologists," implying multiple cardiologists, but the exact number is not provided.
- Qualifications of Experts: "Cardiologists." No specific experience level (e.g., "10 years of experience") is mentioned.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated. The text only says the ECGs were "labeled by cardiologists." The specific method of reconciliation or consensus among cardiologists (if multiple were involved) is not described.
-
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:
- No, an MRMC comparative effectiveness study was not done. The text focuses on the standalone algorithm's performance against expert-labeled ground truth, not on human-AI collaboration or improvement.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone algorithm performance study was done. The text explicitly states, "The AF algorithm was tested in accordance with AAMI/ANSI EC57. ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm." This describes a standalone validation of the algorithm against a ground truth without human-in-the-loop interaction for the validation phase. The device itself is intended for use by individuals and can detect AF, implying a standalone detection capability.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was expert consensus/labeling by cardiologists. The text mentions "ECGs... labeled by cardiologists."
-
The sample size for the training set:
- Not stated. The document refers to "ECGs that were previously recorded using the AliveCor Heart Monitor and labeled by cardiologists were used to validate the performance of the AF algorithm." It does not provide information about a separate training set size. It is possible the validation dataset was also used in some capacity for development or refinement, or the details of the training set are outside the scope of what was provided in this 510(k) summary.
-
How the ground truth for the training set was established:
- Not stated, as the training set details are not provided in the document.
§ 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).