(45 days)
The ConMed" ECG Monitoring Electrodes are pre-gelled, single patient use, disposable electrocardiographic electrodes for use as an accessory to ECG equipment for long term or short term monitoring and diagnostic procedures with regular or diaphoretic adhesives.
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This document is a 510(k) summary for the ConMed™ ECG Monitoring Electrodes. It describes the device, its intended use, and its substantial equivalence to previously marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include information about performance data or ground truth establishment relevant to an AI/algorithm-based device study.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission for a physical medical device (electrodes), not a software or AI-powered device that would typically undergo the kind of performance studies and ground truth establishment you are asking about.
The questions you've posed are appropriate for evaluating an AI/algorithm-driven medical device, but they are not applicable to the traditional medical device described in this 510(k) submission.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.