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Body Signal ECG Electrodes are designed for use in general electrocardiograph procedures, ordered by a physician, where ECG monitoring is deemed necessary during X-Ray or florescence examination. Such procedures include in particular patient ECG surveillance and ECG diagnosis recording.

Body Signal ECG Electrodes are non-sterile products and should not be applied on injured skin surface.

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The provided text is a 510(k) premarket notification letter from the FDA regarding an ECG electrode. It does not contain any information about a study or performance metrics that would allow for the description of acceptance criteria or a study proving its conformance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Information on MRMC comparative effectiveness studies or standalone AI performance.
• Type of ground truth used.
• How ground truth was established for any training set.

The document is a regulatory approval notice, confirming that the "Body Signal ECG Electrode" is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance and the classification of the device.

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