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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 device has not been tested and it is not intended for pediatric use.

The AliveCor Heart Monitor (the device) is the next generation of trans-telephonic (transmission by telephone) 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 AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of atrial fibrillation for each ECG recording.

The provided document is a 510(k) premarket notification for the AliveCor Heart Monitor. It addresses the substantial equivalence of the device to a previously cleared predicate device, but it does not contain the detailed information required to fully answer the request regarding acceptance criteria and the study proving the device meets those criteria.

Specifically, the document states:

• "All necessary performance testing was conducted on the AliveCor Heart Monitor to support a determination of substantial equivalence to the predicate devices."
• "The non-clinical testing included ECG performance evaluation in accordance with IEC 60601-2-47, electrical safety and EMC testing in accordance with IEC 60601-1 and 60601-1-2, and internal verification and validation testing."
• "The collective results of the non-clinical testing demonstrate that the AliveCor Heart Monitor meets the established specifications and complies with the aforementioned standards."

However, it does not provide:

• A table of specific acceptance criteria (e.g., sensitivity, specificity for AF detection) and reported device performance against those criteria.
• Details about a clinical study for the AF detection feature, such as sample size, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone performance metrics.
• Information on the training set for any algorithms, including its size or how its ground truth was established.

Based on the provided text, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

• Information in document: The document references compliance with "established specifications" and standards like IEC 60601-2-47 for ECG performance. However, it does not list specific acceptance criteria (e.g., "AF detection sensitivity > X%") or the exact reported performance values. The primary claim for this 510(k) is substantial equivalence to a predicate device that was "redesigned for aesthetic appeal and functions to the same specifications." This implies that the performance metrics of the new device are expected to be the same as the predicate and meet the standards, but the specific numerical criteria and results are not presented here.

2. Sample size used for the test set and the data provenance

• Information in document: Not explicitly stated for any clinical performance testing related to the AF detection algorithm. The document focuses on non-clinical engineering and safety testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Information in document: Not stated.

4. Adjudication method for the test set

• Information in document: Not stated.

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

• Information in document: No MRMC study is mentioned. The device "detects the presence of atrial fibrillation (when prescribed or used under the care of a physician)" and also allows for human interpretation. This document doesn't detail studies on human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Information in document: The document states, "The AliveCor Heart Monitor can also analyze ECG signals and indicate the presence of atrial fibrillation for each ECG recording." This implies a standalone algorithm for AF detection. However, the specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) and the study that produced them are not included in this summary.

7. The type of ground truth used

• Information in document: Not stated. For AF detection, this would typically involve expert cardiologist over-reads of the ECGs.

8. The sample size for the training set

• Information in document: Not stated.

9. How the ground truth for the training set was established

• Information in document: Not stated.

In summary, this document is a regulatory submission focused on substantial equivalence based on non-clinical engineering and safety testing, confirming the device meets established specifications and regulatory standards. It does not provide the detailed clinical performance study results (especially for the AF detection feature) that would answer questions 1-9 comprehensively. Such details would typically be found in a more extensive clinical study report or a different section of the 510(k) submission, not summarized in the provided text.

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