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Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.

The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.

Neuronaute allows up to 24 channels EEG monitoring. It includes the following components: Neuronaute Head Module, Neuronaute High Capacity Battery Module, Neuronaute BioAdapter, Neuronaute Mobile App, Neuronaute N-CLOUD, Neuronaute N-DEO, Neuronaute N-WAY, Neuronaute IceCap.

The provided text describes the Neuronaute device, an electroencephalograph (EEG) system, and its substantial equivalence to a predicate device (AE-120A EEG Head Set, K183529) for FDA clearance. However, it does not contain a specific study demonstrating that the device meets numerically defined acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for a particular condition). Instead, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing against recognized standards.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as a clinical performance study with such metrics was not submitted.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As a clinical performance study with specific diagnostic metrics (like sensitivity, specificity, or accuracy) was not submitted, there isn't a table of acceptance criteria for diagnostic performance against specific disease states. Instead, the acceptance is based on meeting technical and safety standards, and demonstrating signal quality, all of which are considered "performance" in this context.

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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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