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The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment.
Headpiece (42-48 cm) for EEG Monitoring

The small e-Net is designed to fit patients with a head size in the range of 42 - 48 cm in circumference. It is constructed using the same materials and manufacturing processes as the larger sized net 54 - 62 cm) which is described in K930080. The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment. The small e-Net is fabricated from the same materials as the larger version. Only the size of the components was reduced to achieve the proportional fir on the intended head sizes.

The provided text is a 510(k) premarket notification for a medical device (Physiometrix, Inc.'s Small e-Net Model 1240). However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Description: What the small e-Net is, its intended use (EEG monitoring for head sizes 42-48 cm), and its construction.
• Regulatory Classification: Identifying it as a Class II cutaneous electrode and its predicate device.
• FDA Substantially Equivalent Letter: This letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It also outlines general control provisions and regulatory responsibilities.

Therefore, I cannot provide the requested table and study details based on the given input. The document is a regulatory approval notice, not a performance study report.

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