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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.

The Medium e-Net is designed to fit patients with a head size in the range of 48 - 54 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 Medium e-Net is fabricated from the same materials as the larger version. Only the size of the components was reduced to achieve the proportional fit on the intended head sizes.

The provided text describes a 510(k) premarket notification for the Physiometrix, Inc. HydroSpot System, Model 1500 & 1501, and specifically the Medium e-Net Model 1210. However, the document does not contain information about acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc. The document is primarily a regulatory approval letter based on substantial equivalence to a predicate device (K930080, HydroDot NeuroMonitoring System).

Here's a breakdown of why I cannot fulfill your request for performance data, and what information is available in the provided text:

Missing Information:

• Acceptance Criteria & Reported Device Performance: This document does not specify any quantitative performance metrics (like accuracy, sensitivity, specificity, etc.) nor their acceptance criteria. It primarily asserts that the device is "substantially equivalent" to a predicate device.
• Sample Size for Test Set & Data Provenance: No information on a test set, its size, or the provenance of the data is provided.
• Number of Experts & Qualifications for Ground Truth: No mention of experts or ground truth establishment for a test set.
• Adjudication Method: Not applicable as no test set evaluation is described.
• MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The device in question is a physical electrode net, not an AI algorithm.
• Standalone Performance Study: No standalone algorithmic performance study is mentioned.
• Type of Ground Truth Used: Not applicable, as no performance study is described.
• Sample Size for Training Set: No information on a training set is provided.
• How Ground Truth for Training Set was Established: Not applicable.

Information Available related to Substantial Equivalence:

The document states that the new device (Medium e-Net, Model 1210) is substantially equivalent to a predicate device (HydroDot NeuroMonitoring System, K930080). This determination is based on the following:

• Intended Use: "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." This is consistent with its role as a "Cutaneous Electrode" for "EEG Monitoring."
• Design/Materials: "The Medium e-Net is fabricated from the same materials as the larger version [predicate device]. Only the size of the components was reduced to achieve the proportional fit on the intended head sizes."

Regarding "Acceptance Criteria" and "Study" and "Reported Device Performance":

In the context of this 510(k) submission, the "acceptance criteria" for the device to be cleared were based on demonstrating substantial equivalence to a previously cleared predicate device. The "study" that proves this is primarily a comparison of the new device's technological characteristics, materials, and intended use to the predicate device.

Since this device is a physical cutaneous electrode and not an AI/software device, the concepts of sensitivity, specificity, training sets, test sets, expert ground truth adjudication, and MRMC studies as typically applied to diagnostic AI are not relevant here. The substantial equivalence argument relies on the device being made of similar materials, having similar design principles (just scaled for different head sizes), and serving the same intended purpose as the predicate device. The 510(k) summary (K960873) explicitly compares the new device (Model 1210 Medium e-Net) to the predicate (K930080 HydroDot NeuroMonitoring System) based on physical attributes and intended function.

Therefore, I cannot populate the table or answer most of your questions as the provided text does not contain the type of performance study data you are asking for. It's a regulatory clearance document based on substantial equivalence, not a performance study report for a diagnostic algorithm.

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