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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 and normal sinus rhythm (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 noise, normal sinus rhythm and atrial fibrillation for each ECG recording.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the AliveCor Heart Monitor:

Note: The provided document is a 510(k) summary, which often provides less detailed information about specific study designs and acceptance criteria than a full clinical study report. Therefore, some information might be missing or inferred.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state the acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity thresholds) for atrial fibrillation or normal sinus rhythm detection. It generally states 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."

However, it does reference AAMI/ANSI EC57: 2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms. This standard typically outlines performance requirements for such algorithms, implying that the acceptance criteria would align with those specified in EC57. Without the full study report, the exact numerical thresholds for sensitivity and specificity are not available.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "The databases recommended by EC57 and data captured from the AliveCor Heart Monitor were used to validate the algorithms' performance."

• Sample Size for Test Set: Not explicitly stated. The EC57 standard recommends specific databases, but the exact number of ECGs used from these databases for validation is not provided in this summary.
• Data Provenance:
  • Country of Origin: Not specified for the EC57 recommended databases. For "data captured from the AliveCor Heart Monitor," the country of origin is not specified, but the applicant is US-based.
  • Retrospective or Prospective: Not explicitly stated. Database usage often implies retrospective data. "Data captured from the AliveCor Heart Monitor" could be either, but given the context of algorithm validation, it's likely a pre-existing dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the 510(k) summary. When leveraging external databases like those recommended by EC57, the ground truth is typically established by expert cardiologists; however, the number and their specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

The adjudication method is not specified in the 510(k) summary. If external databases were used, the ground truth within those databases would have been established through a documented adjudication process by the creators of those databases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with or without AI assistance was not mentioned in this 510(k) summary. This submission appears to be focused on the standalone performance of the device's algorithms.

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

Yes, a standalone performance study of the algorithm was done. The document explicitly states: "The non-clinical testing included... algorithm validation to demonstrate... the performance of the algorithms." The indications for use also state the device "detects the presence of atrial fibrillation and normal sinus rhythm," implying automated detection.

7. The Type of Ground Truth Used

The ground truth was based on expert consensus embedded within the "databases recommended by EC57" and "data captured from the AliveCor Heart Monitor." For rhythm analysis, this typically means human experts (cardiologists or electrophysiologists) manually reviewed and annotated the ECGs to establish the true rhythm diagnosis (e.g., atrial fibrillation, normal sinus rhythm).

8. The Sample Size for the Training Set

The sample size for the training set is not explicitly stated in this 510(k) summary. The document focuses on the validation of the algorithms, which uses a separate test set.

9. How the Ground Truth for the Training Set Was Established

The method for establishing ground truth for the training set is not explicitly stated in this 510(k) summary. It's generally assumed that similar methods to the test set (expert consensus) would have been used for training data, but no details are provided here.

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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 document provided is a 510(k) summary for the AliveCor Heart Monitor, which is a premarket notification for a medical device seeking clearance from the FDA. This type of document aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

However, the provided text does not contain the detailed acceptance criteria for a study proving the device meets those criteria, nor does it detail a study that would typically include the information you've requested (such as sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies).

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."

This indicates that general performance and safety standards were met, but it does not describe a clinical study with specific acceptance criteria related to diagnostic accuracy (e.g., sensitivity, specificity for AF detection) and how those criteria were met using a ground truth established by experts.

The only specific diagnostic claim mentioned is the detection of atrial fibrillation: "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)." However, the document does not provide the performance metrics (e.g., sensitivity, specificity) for this detection, or the details of the study that validated this capability.

Therefore, based solely on the provided text, I cannot complete the table or answer most of your detailed questions regarding acceptance criteria and the specifics of a study proving those criteria. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and general compliance with standards, rather than providing the results of a detailed clinical performance study with defined diagnostic acceptance criteria.

To answer your questions, I would need additional information, likely contained in a more detailed clinical study report that would form part of the full 510(k) submission, but is not present in this summary document.

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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 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

Study Details Proving Acceptance Criteria

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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."

7. 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.

8. How the ground truth for the training set was established:

   • Not stated, as the training set details are not provided in the document.

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The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms.

Not Found

The provided text is a 510(k) premarket notification for the AliveCor Heart Monitor. However, the document does not contain the following information:

• Acceptance criteria and reported device performance table. The submission does not detail specific performance metrics (e.g., sensitivity, specificity, accuracy) or the targets for these metrics that the device had to meet.
• Study details about sample sizes, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training/test set ground truth establishment. The document serves as an FDA clearance letter and an Indications for Use statement, not a detailed technical report of a performance study.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

The closest relevant information available in the document is the Indications for Use Statement:

• Device Names: AliveCor Heart Monitor
• Indications for Use: The AliveCor Heart Monitor is intended to record, display (when prescribed or used under the care of a physician), store and transfer single-channel electrocardiogram (ECG) rhythms.

To answer your prompt with the requested details, a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report, would be necessary.

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The AliveCor Heart Monitor is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to AliveCor, Inc. for their "AliveCor Heart Monitor." This document primarily grants substantial equivalence based on indications for use and general regulatory compliance. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot answer your request based on the provided input. This document is a regulatory approval letter, not a clinical study report or a technical performance evaluation.

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The AliveCor Heart Monitor for iPhone is intended for use by licensed medical professionals or patients to record, display, store and transfer single-channel electrocardiogram (ECG) rhythms.

Not Found

This document is a 510(k) premarket notification from the FDA for the AliveCor Heart Monitor for iPhone. It acknowledges the receipt and review of the device and states that it is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a notification of substantial equivalence, not a detailed report of clinical trials or performance metrics.

Therefore, I cannot provide the requested information based on the provided text.

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