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The NeuroCap (Model DEC22) is an Electroencephalogram (EEG) electrode array intended for use in routine clinical and research settings where recording of STAT EEGs is desired.

NeuroCap is a disposable electrodes system made of polycarbonate-based film with applied conductive paths and sensors. Each Ag/AgCl sensor is equipped with a sponge that is coated with a conductive gel for providing sensor contact with the scalp (cutaneous) surface. NeuroCap is fixed on the patient by means of adhesive tape and Velcro. NeuroCap could be connected to a signal amplifier directly or via a special adapter. (The adapter will not be included in the subject device.) The practical application of the NeuroCap is in electroencephalography.

The NeuroCap disposable electrode system has 19 active channels. The headband of the device is nonsterile and disposable for single patient use. The NeuroCap is designed to be used with the Neuro EEG Device (K173460) for EEG acquisition and recording. The Neuro EEG Device is sold separately.

NeuroCap is intended for prescription use in healthcare facilities or clinical research environments. NeuroCap is not intended for current stimulation and must be used by qualified personnel.

The provided document is a 510(k) summary for the NeuroCap (Model DEC22), an Electroencephalogram (EEG) electrode array. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, the document does not contain the kind of detailed information about acceptance criteria, clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets, or training set size/ground truth establishment) that would be expected for a device with a new AI/ML component or a novel performance claim requiring extensive validation studies.

The "Test Summary" section only lists:

• Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
• Risk management according to ISO 14971: 2012 standards
• Performance test according to ANSI/AAMI EC12: 2000 Disposable ECG electrodes standards

These are standard engineering and safety tests for an electrode, not clinical performance studies for an AI/ML algorithm.

Therefore, it is not possible to fill out the requested table or answer the questions related to AI/ML device performance studies based on the provided text.

The document concludes that the device is "substantially equivalent" to predicate devices based on technological characteristics, features, specifications, mode of operation, and intended use, and that "The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness." This implies that extensive clinical performance studies to prove specific performance metrics were not required beyond demonstrating equivalence to existing devices.

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