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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.

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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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