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The CUP Electrodes are intended for non-invasive use with recording and monitoring equipment,(active and reference), of Electroencephalograph (EEG), electromyography (EMG)and Evoked Potentials(EP).

A cutaneous electrode is an electrode that is applied directly to a patient's skin to record physiological signals. In other words cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph(EEG), Electromyograph(EMG), and Evoked Potentials(EP) and the electroencephalograph/evoked potentials reading is completely non-invasive procedure that can be applied to children and adult patients. The electrodes are delivered non-sterile and are available in disposable version. DAEHAN Disposable CUP electrodes are for single patient use only. The electrodes have a disc manufactured of molded ABS, Ag/agcl plated. The disc is permanently adhered to a lead wire. The insulated lead wires terminate using a molded touch proof connector (DIN 42 802) for electrical safety.

This document is a 510(k) Summary for the DAEHAN Disposable CUP Electrodes. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the results of a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The acceptance criteria mentioned in this document are for the DAEHAN Disposable CUP Electrodes as a cutaneous electrode, and the "studies" relate to general device performance and regulatory compliance for medical devices, not AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them based on the provided text.

Specifically, the document discusses:

1. Non-Clinical Test Summary:
   • Biocompatibility: "Identical materials are used in legally marketed device"
   • Performance Testing:
     • Bond Test
     • Electrical Properties Test (AAMI/ANSI EC12: Disposable ECG Electrodes, IEC 60601-1 Ed3.1 CL 8.5.2.3: Patient Leads)
   • Shelf-life Testing (ASTM F1980-02)

These are standard tests for physical medical devices and do not involve AI/ML performance metrics like sensitivity, specificity, or AUC, nor do they involve a test set, ground truth established by experts, or MRMC studies.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to extract the requested information.

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