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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.

EEG recording in OR environment.

Headpiece for EEG Monitoring in Operating Room

The OR e-Net is designed to fit patients with a head size in the range of 54 - 62 cm in circumference. It is constructed using the same materials and manufacturing processes as the predicate device, Large e-Net 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 OR e-Net is fabricated from the same materials as the larger version. Two changes were made to make the product more suitable for the OR environment. First, the material located below the ear was removed and secondly, the inion tab was extended to allow it be secured to the neck.

The provided text for device K961609 (Physiometrix, Inc., OR e-Net) is a regulatory document (510(k) Premarket Notification summary and an FDA letter), which focuses on device description, intended use, and substantial equivalence to a predicate device. It does not contain information about acceptance criteria or specific study data to prove performance against those criteria.

Therefore, I cannot populate the requested table or answer most of the questions, as the necessary information is not present in the provided text.

Here's what I can state based on the available information:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not specified in the provided text.
   • Reported Device Performance: Not specified in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. The document primarily describes the device and its regulatory status, not a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable as no performance study is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as no performance study is detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study or AI assistance is mentioned. This device is a passive EEG electrode net, not an AI-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a passive EEG electrode net.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable as no performance study is detailed.

8. The sample size for the training set:

   • Not applicable as no machine learning algorithm or training set is mentioned for this device.

9. How the ground truth for the training set was established:

   • Not applicable as no machine learning algorithm or training set is mentioned.

Summary of available information related to performance/validation:

The document for K961609 describes the OR e-Net as being designed to fit patients with a head size of 54 - 62 cm. It states that the device is "constructed using the same materials and manufacturing processes as the predicate device, Large e-Net which is described in K930080." It also mentions "Two changes were made to make the product more suitable for the OR environment. First, the material located below the ear was removed and secondly, the inion tab was extended to allow it be secured to the neck."

The basis for clearance is substantial equivalence to the predicate device K930080 (HydroDot NeuroMonitoring System), implying that its performance characteristics are similar or identical, given the material and manufacturing commonalities, and minor design changes focused on OR suitability rather than fundamental function. The document does not detail specific performance studies, rather it relies on the similarity to the already cleared predicate device.

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