(75 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 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.
§ 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).