(5 days)
The 12 Lead Simultaneous Cable is used to acquire a patient's ECG via 10 leads connected to a patient's chest. It converts the ECG signal into a digital format and transfers this information to a Micromedical monitor or software system using a proprietary digital data transfer protocol.
The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical monitor or to a software system to display the ECG signal on a personal computer.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a "Modified 12 Lead Simultaneous Cable" and a letter from the FDA. It outlines the device description, its intended use, and states that "Nonclinical testing was performed to assure that the device works with the Cardio View 3000 software." However, it does not provide any specific details about the acceptance criteria for this testing, the methods used, or the results.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, ground truth, experts, adjudication, MRMC studies, or standalone performance.
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