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The NeuralScan System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and Event-related Potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

The NeuralScan System is comprised of the NeuralScan Amplifier with embedded firmware for acquisition and transmission of physiological signals, an EEG cap, a Subject Response Device, a laptop computer preloaded with the NeuralScan Evoke software, and a charging kit (that consists of a USB cable, clip kit, and wall adapter).

The NeuralScan Evoke software runs in a Windows Operating System environment and controls the 23 channel (21 EEG and 2 bio channels) NeuralScan EEG amplifier via a USB cable or Wi-Fi connection. The software has a graphical user interface that allows the user to input patient information, create new records, conduct studies to collect EEG and ERP data, view live data streams of the laptop display, record data to a file, analyze resultant test data using standard Frequency EEG analysis and EP display methods and print the results. The software includes a mode to measure the cap electrode impedances which is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. Interpretation of the data is the responsibility of the physician as the software does not provide any diagnosis based on the data.

The patient contacting accessories are commercially sourced and used without modification. The device and the accessories are not sterile and are not intended to be sterilized.

The provided text describes the regulatory clearance for the "NeuralScan System" and includes a summary of non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. However, it explicitly states: "No Clinical testing was necessary to determine substantial equivalence."

Therefore, based on the provided document, the device did not undergo a clinical study involving human subjects to prove its performance against acceptance criteria for diagnostic accuracy or clinical effectiveness. The acceptance criteria and performance data are entirely based on bench testing (non-clinical data) for the device's functional integrity as an electroencephalograph (EEG) and Event-related Potentials (ERP) system.

Given this, I can only provide information derived from the non-clinical testing detailed in the document.

Acceptance Criteria and Reported Device Performance (Non-Clinical Study)

The acceptance criteria and performance measurements for the NeuralScan System are based on bench testing to confirm compliance with recognized medical device standards (primarily IEC 60601-2-26 for electroencephalographs). These tests evaluate the hardware and software's ability to accurately acquire, reproduce, and transmit physiological signals.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the specific configurations and conditions used for the bench tests. For each test, specific signal parameters and conditions were applied.
• Data Provenance: Not applicable as no clinical patient data was used. The data is generated from controlled laboratory bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for these tests are the precise, known input signals generated by test equipment, and validation against the specified international standards (IEC 60601-2-26). No human experts were involved in establishing the ground truth for these non-clinical tests in the way they would be for diagnostic accuracy studies.

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

• Not applicable. Adjudication methods are relevant for clinical studies where human interpretation of medical images or data is being evaluated. For bench testing, the results are objectively measured against established engineering and performance specifications.

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 clinical study was performed. The document explicitly states, "No Clinical testing was necessary to determine substantial equivalence." This device is intended for the acquisition, display, and storage of EEG/ERP data to aid in diagnosis, with interpretation being the responsibility of a physician. It does not appear to incorporate an AI component for automated diagnostic interpretation or decision support that would necessitate an MRMC study to show AI assistance to human readers.

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

• No standalone clinical performance testing was performed. The device's performance was evaluated through non-clinical bench testing for its technical specifications and compliance with safety and performance standards relevant to EEG/ERP systems.

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

• The ground truth for the non-clinical tests was established by defined input signals and test methods outlined in international standards (IEC 60601-2-26). It is an objective, quantitative ground truth based on engineering principles, rather than clinical consensus or pathological findings.

8. The sample size for the training set:

• Not applicable. The document does not describe the use of machine learning or AI that would require a "training set" in the conventional sense for diagnostic algorithm development. The hardware and software verification and validation were performed on the device itself.

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

• Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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