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WAV SCAN EEG 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.

WAVi™ SCAN EEG system (WAVi™ SCAN 1.0) is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and eventrelated potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. The medical system includes the "WAVi™ EPU" (Electronic Processing Unit), an EEG amplifier intended to be used with EEG accessories cleared in K162460 and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with WAVI™ SCAN 1.0 include an EEG cap, the WAVI™ EPU, headphones, a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device programming. The WAVI EEG System's software includes electronic versions of standardized clinical assessment tools related to psychiatry and neuropsychological evaluation but are provided for convenience and are to be used in accordance with the assessment tools' specific general instructions. These tools do not interact with any other of the EEG system's hardware and software measures and are stand alone.

The WAVi Scan EEG System has acceptance criteria primarily related to its electrical performance and adherence to established medical device standards. The study presented is a pre-market notification (510(k)) submission to the FDA, which demonstrates substantial equivalence to predicate devices rather than a comparative effectiveness study in the traditional sense of human reader improvement.

Here's a breakdown of the acceptance criteria and the study's proof of meeting them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from recognized international standards for electroencephalographs, particularly IEC 80601-2-26:2019, and general electrical safety and electromagnetic compatibility (EMC) standards. The study demonstrates conformance to these standards.

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The WAV Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

The WAVI™ Headset is an EEG electrode positioning system used to quickly place the electrodes in a uniform and consistent manner in accordance with the international standard Ten-Twenty System (10-20) to acquire electrophysiological EEG signals from an individual to a suitable EEG data collection device.

The device consists of the WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Electrode Contacts; the head set comes in five models/sizes (XS, S, M, L, XL). This device is portable, nonsterile, non-invasive, non-radiation emitting, point-of-care use device for use in healthcare facilities and hospitals.

Device characteristics include the eSoc™ Single Use Electrode Contacts which are soaked in 0.9% Normal Saline which is unique as it serves as the electro-conductive material and patient contact allowing the brain's electrical signals to be read through an EEG data collection device. Typical set-up and procedure time is less than twenty minutes.

The device does not contain software, biologics, drugs, coatings or any claim of sterility.

The WAVI™ Headset, eSoc™ Single Use and Ear Electrode Contacts are made from wellestablished medical grade materials; the Headset is made from a proprietary EVA material with tin plated ring electrode ports for placement of the Nylon 101 WAVi™ eSoc™ Single Use Electrode Contacts, and two ear electrodes are also made from Tin. A wire harness is embedded between two layers of EVA and is attached to each electrode port. The wire harness exits the headset to a 32-pin connector port.

This document describes the WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts, a device intended for rapid placement of EEG electrodes in clinical and research settings.

Here's an analysis of the provided information concerning acceptance criteria and the study proving device performance:

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

The document does not explicitly present a formal table of "acceptance criteria" for the device's technical or diagnostic performance in the way one might expect for an AI algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Electro-Cap™ System) based on technical characteristics and a comparative study.

However, we can infer performance requirements from the comparison table on page 5 and the non-clinical testing section:

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

• Sample Size for Test Set: 3 test subjects.
• Data Provenance: Not specified, but likely from the US, given the submission to the US FDA. The study appears to be prospective as it involved a direct comparison on test subjects.

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

The concept of "experts" establishing ground truth in the context of diagnostic interpretation (e.g., radiologists for images) is not directly applicable here. The device is an EEG electrode positioning system, not a diagnostic interpretation tool. The "ground truth" for its performance is the direct comparison of its generated EEG signals against those from a legally marketed predicate device on the same subjects, as measured by an objective EEG device (Lexicor Neurosearch-24 Brain mapper). There's no mention of human interpretive "experts" in this part of the study.

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

None. Adjudication methods are typically used when human interpretation or labeling creates the "ground truth" and discrepancies need to be resolved. In this device comparison, the output (EEG spectral shapes and maximum frequencies) was objectively measured by an EEG Brain Mapper (Lexicor Neurosearch-24). The consistency of these measurements between the two devices across subjects was the metric.

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. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting output that would then be compared to AI assistance. It's an electrode placement device; the comparison is between its raw signal output and that of a predicate device.

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

Yes, in spirit. The study primarily assesses the device's ability to consistently acquire EEG signals in comparison to the predicate. The "performance" being evaluated is of the device itself (headset and electrodes) in generating electrical signals, rather than an algorithm's output. The Lexicor Neurosearch-24 Brain mapper served as the objective measurement tool, not a human interpreter.

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

The "ground truth" in this context is the EEG signals generated by the legally marketed predicate device (Electro-Cap™ System) under the same conditions, as objectively measured by a Lexicor Neurosearch-24 Brain mapper. The assumption is that the predicate device's output represents acceptable EEG signal acquisition.

8. The sample size for the training set

Not applicable. This device is a hardware accessory for EEG signal acquisition, not an algorithm that requires a training set. The approval is based on substantial equivalence to an existing device and its physical and electrical characteristics.

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

Not applicable. No training set was used for this device.

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