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The NEON EEG is intended to be applied directly to the patient's scalp to enable recordings of electrophysiological signals (such as EEG) on infants from birth. The NEON EEG is indicated for single use only and should be replaced after 12 hours of use. The NEON EEG is not indicated for use with electro stimulation equipment.

The NEON EEG consists of an array of pre-gelled electrodes that are sized to fit an infant's scalp. The electrodes are screen-printed in Ag/AgCl ink on a flexible polyester substrate and are pre-gelled with industry-standard electrode paste. The electrode array substrate has a thin layer of inert foam. The electrode array connects to a monitoring machine by an interface cable with medically-recognized safety end fittings ("touch proof" or "D type"). The safety connector is connected to the electrically and patient-isolated pre-amplifier input of a neuro-diagnostic or neuro-monitoring equipment. The NEON electrode array is sized to fit new-born infants and has a reduced lead set of 5 pairs of electrodes, plus a Ground and Reference. The positioning of the electrodes is based upon the principles of the 10-20 placement system, with individual electrodes labeled with their 10-20 nomenclature. The shape of the array is designed to allow access to the scalp, co-exist with other monitoring requirements, and allow free circulation of air. An industry-standard EEG electrolyte gel is supplied to allow optional application on individual electrodes sites.

It appears the provided document is a 510(k) summary for a medical device called "NEON EEG," which is a cutaneous electrode intended for recording electrophysiological signals (like EEG) on infants.

However, the document does not contain a study or data proving the device meets specific acceptance criteria in the way you've outlined. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: Similar purpose.
• Technological Characteristics: Similar materials (Ag/AgCl ink, pre-gelled electrodes, polyester substrate, foam backing), similar connection to monitoring equipment, adherence to 10-20 placement system principles.
• Principles of Operation: Implied to be the same as other EEG electrodes.
• Performance Standards: Compliance with IEC60601-1-2:2007 (EMC), AAMI EC12: 2005 (Disposable ECG electrodes), and IEEE 2010:2012 (Neurofeedback Systems). The document states, "In all instances, the NEON EEG functioned as intended." This is a general statement of compliance, not a detailed study with specific performance metrics and acceptance thresholds.

The document emphasizes that differences are minor (e.g., sizing for infants, number of electrodes to fit a smaller scalp) and "raise no new issues of safety or effectiveness." It concludes that "Performance data demonstrate that the NEON EEG is safe and effective in use. Thus, the NEON EEG is substantially equivalent." without detailing what this performance data entails.

Therefore, I cannot fill out your requested table and study information as the provided text does not contain the specific data points you're looking for (e.g., quantitative acceptance criteria, reported performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

To summarize why I cannot provide the requested information:

• No explicit acceptance criteria table: The document references compliance with performance standards (IEC, AAMI, IEEE) but doesn't define specific quantitative "acceptance criteria" and "reported device performance" in a structured table for the device's primary function (EEG signal quality, impedance, etc.).
• No detailed study data: The 510(k) summary is designed to establish substantial equivalence, not to present a detailed clinical or performance study with quantified results, sample sizes, or ground truth methodologies.
• Focus on Substantial Equivalence: The approval is based on equivalence to predicate devices, implying that if the predicate devices are safe and effective, and the new device is sufficiently similar, it also is. This approach often doesn't require new, extensive clinical performance studies to the same degree as a PMA.
• Device Type: This is a cutaneous electrode, which is a fairly mature and well-understood technology. The "safety and effectiveness" cited likely refers to standard electrical safety, biocompatibility, and basic signal integrity, rather than complex diagnostic accuracy.

If you have a document that details a specific performance study with quantitative results, I would be able to answer your questions.

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