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The Comby EEG Cap is intended for use in routine clinical settings where rapid placement of large number of EEG electrodes is desired.

The Comby EEG Cap is an electrode positioning system used to quickly place the standard 20 EEG electrodes or more in a uniform and consistent manner on the head and body in order to transmit electrophysiological signals from an individual to data collection devices. The Comby EEG Cap is made from high quality profile rubber net, electrode plastic holders made of SEBS and electrodes. Electrodes is made of two different conductors, sintered Ag/AgCl and gold coated plates. The EEG Comby Cap is fixed by Velcro tape holders which are fastened beneath the chin of the tested person. The cap holders is fixed to a belt, placed beneath the arms and around the chest of the tested person. The high quality profile rubber net holds the electrodes securely in position during the EEG recording. Wires are attached to each electrode and exit the cap to form a cable, which is used to connect the cap to the EEG equipment, either through an adapter cable, or directly to the equipment with the 25-pin D-sub connector. The electrical activity of the brain is transferred through the conductive Electro-Gel/paste to the recessed electrode and then to the EEG or computer equipment for evaluation. The electrodes on the standard caps are positioned in accordance with the International 10-20 System of electrode placement. In addition, the Comby EEG Cap with as few as 2 to as many as 64 electrodes. Comby EEG are also produced based on customer specified electrode placements, with electrodes made of Ag/AgC1 material. Customized wiring and connectors offer additional options.

The provided document is a 510(k) premarket notification for a medical device called the "Comby EEG Cap." It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving a novel device meets specific performance criteria through a rigorous clinical trial or AI model validation study.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/ML device, nor does it describe a study (including sample sizes, expert ground truth, MRMC studies, or training/test set details) that proves a device meets such criteria.

The document primarily addresses:

• Device Description: What the Comby EEG Cap is, its components, and how it functions.
• Intended Use: For routine clinical settings where rapid placement of EEG electrodes is desired.
• Predicate Devices: Comparison to other EEG electrode systems already on the market.
• Bench Testing: Reference to performance testing against ANSI/AAMI EC12:2000 (R2015) for Disposable ECG Electrodes (not specific to EEG performance or AI capabilities).
• Biocompatibility: Testing conducted per ISO standards.
• Substantial Equivalence: The overall argument for why this device is equivalent to existing ones.

The document explicitly states:

• "Clinical Data: Clinical testing is not required" (page 6)
• "Clinical testing is not required" (page 7)

This indicates that the device's clearance did not rely on clinical performance data proving specific diagnostic or treatment effectiveness beyond basic safety and electrical performance characteristics of electrodes. It is a traditional medical device, not an AI/ML powered one, thus the typical AI/ML validation study elements (acceptance criteria for AI performance, MRMC studies, ground truth establishment, training/test set details) are not present.

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