(287 days)
The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.
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I understand you're asking for details about the acceptance criteria and study data for a medical device. However, the provided text is an FDA 510(k) clearance letter for the Ivy Biomedical Model 7600EP/7800EP Cardiac Synchronization Monitor.
This document explicitly states that the device is a "Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" and is intended to "provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization."
This is not an AI/ML medical device, and the provided text does not contain any information about acceptance criteria, study data, ground truth establishment, or any of the other AI/ML-specific details you are asking for.
Therefore, I cannot extract the information requested for a study proving an AI/ML device meets acceptance criteria, as the document concerns a traditional medical device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).