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The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform.

cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.Hlamp.

cortiQ PRO is a system that uses g.Hlamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the highgamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.

cortiQ PRO reads in the digital data from the g.Hlamp amplification system (1200 Hz sampling frequency, up to 256 channels) via USB into the processing computer. The data is acquired without bandpass and notch filtering and without bipolar derivation. The software allows one to select the channels that should be acquired and stores the raw data together with header information for later off-line analysis.

Raw data is visualized on a raw data scope to inspect the data quality. The scope allows scaling of the data in amplitude and time. Furthermore the software allows scaling of all the channels to the same amplitude to make the interpretation easier. In the scope, it is possible to select a new ground and reference channel and to exclude a channel from the processing (if the data quality is bad). The raw data scope filters the data with a high-pass filter to remove DC-offsets for optimal visualization.

cortiQ PRO allows the operator to select an experimental paradigm that instructs the patient to perform certain tasks. The instructions are presented on a patient computer screen or are given via a speaker. The user can select, start and terminate the experimental paradigm. Additionally, the number of repetitions can be selected. A dedicated paradigm editor creates new paradigm files or modifies existing paradigms.

The rapid cortical mapping functions perform a common average reference (CAR) of all the active channels to remove common mode signals such as power line interference. Then the module calculates the high-gamma activity in certain frequency ranges for the different tasks and compares the high-gamma activity to those of another task according to the selected paradigm. Then a statistical analysis is performed and significant activation is plotted as bubble on the defined electrode position in order to identify important regions. When the mapping has ended, cortiQ PRO automatically generates a mapping report containing the montage definition, the paradigm definition, and the mapping results. This report is stored as pdf and can be printed. The mapping result is also stored for later analysis.

cortiQ PRO allows the operator to define montage definition files in the montage creator by loading predefined electrode grids from different manufacturers. Each grid has a certain number of channels. The montage creator allows the operator to assign a patient's name and date of birth, and a montage name to each file. Furthermore, it allows the operator to assign a grid name to each electrode grid. The grids can be placed on different background images to make the location interpretation easier. Electrodes from a grid can be disabled, used as reference or as ground electrodes. The grids can be resized or rotated. The montage creator assigns also the electrode grids automatically to the amplifier inputs channels and creates a report with the channel definition. The results can be stored to be modified later. The report is stored as pdf and can be printed.

cortiQ PRO comes with an installs the software under Windows. A hardlock is required to start the mapping software.

The mapping system comes with Instructions for use and a training program.

The provided 510(k) summary for the cortiQ PRO device does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format as typically found in comprehensive clinical or performance studies. Instead, it offers a general statement about performance testing.

Here's an attempt to extract and present the information based on the available text:

Acceptance Criteria and Device Performance

The documentation states: "The testing showed that the difference in gamma activity can be correctly mapped to correct electrode channels." This is the primary functional performance claim related to the core function of the device in evaluating high-gamma brain activity. However, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, or minimum R2 values) are not explicitly provided in the given text, nor are specific reported device performance metrics in a tabular format.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred)

Study Details

The provided text describes performance testing, but not a formal clinical study with detailed methodology typically associated with "acceptance criteria" and "device performance" in a quantitative sense.

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

   • Test Set: "several real electrocorticographic (ECoG) and artificial test signals." No specific number is given for "several."
   • Data Provenance: Not specified, but "real electrocorticographic (ECoG) data" would likely be from human subjects, potentially clinical. "Artificial test signals" are generated. Whether these ECoG data were prospective or retrospective is not stated. Country of origin is not specified.

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

   • This information is not provided in the document. The ground truth for artificial signals is inherent in their design. For real ECoG data, how "task-related differences" were confirmed as ground truth is not detailed, nor is the involvement of experts in establishing this ground truth.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of the testing described (mapping gamma activity), it's unclear if an adjudication method between multiple readers/interpreters was necessary or employed.

4. 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:

   • A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The cortiQ PRO is described as a system for statistical evaluation and visualization of brain activity, intended to be interpreted in conjunction with review of the original EEG waveform and dependent upon the judgement of the clinician. This implies human-in-the-loop, but without a formal MRMC study evaluating improvement with AI assistance.

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

   • The description of the testing ("The testing showed that the difference in gamma activity can be correctly mapped...") suggests performance validation of the algorithm's ability to identify and map differences in gamma activity. This can be interpreted as a form of standalone performance evaluation for its core function. However, the device's indications for use emphasize that measures "should always be interpreted in conjunction with review of the original EEG waveform," implying it is not intended for fully standalone diagnostic interpretation.

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

   • For artificial test signals: The ground truth is the inherent design of the signals, where "lower amplitude in the task baseline interval" and "higher amplitude in the action interval" on specific channels define the expected difference.
   • For real electrocorticographic (ECoG) data: The ground truth relies on "task-related differences in the high-gamma frequency band." How these differences are definitively established as "ground truth" (e.g., through other modalities, expert consensus, surgical outcomes) is not explicitly stated.

7. The sample size for the training set:

   • This information is not provided. The document describes performance testing but does not detail the development or training of the algorithm that identifies "high-gamma broad band brain activity."

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

   • This information is not provided as details about a training set are absent.

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