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The BNA™ Platform is to be used by qualified medical professionals for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), including event-related potentials ("ERPs').

This device is indicated for use in individuals 12 to 85 years of age.

The BNA™ Platform is to be used with the Auditory Oddball, Visual Go No-Go (age range of 25 to 85 years), and Eyes-Closed tasks.

The BNATM Platform is intended for the post-hoc statistical analysis of the human electroencephalogram ("EEG"), utilizing both resting-state EEG and Event-Related Potentials ("ERP") in a patient's response to outside stimuli during various states of alertness, disease, diagnostic testing, treatment, surgery, or drug related dysfunction. An Event-Related Potential (or "evoked response") is an electrical potential recorded from the nervous system following the presentation of a stimulus (e.g., as part of a cognitive task). An ERP signal consists of typical ERP components - positive or negative voltage spatiotemporal peaks within the ERP waveform that are measured within one second post-stimulus presentation. The BNATM Platform is intended to analyze EEG data recorded at rest and during the performance of two conventionally used ERP tasks, the Auditory Oddball (AOB) and the Visual Go No-Go (VGNG).

The EEG is recorded continuously while the patient is at rest with eyes-closed (hereby Eyes-Closed) or performs one of the ERP tasks (hereby ERP tasks). The acquisition site is asked to provide reliable samples of artifact-free digital EEG for purposes of analysis. After the recording, the artifact-free EEG data is imported into the BNATM Platform and is automatically analyzed by the algorithm and the results of the processed data are compiled into individualized Reports:

• . ERP Report
• Behavioral Report ●
• . Summary Report
• Resting-State EEG Report ●

Scores are presented as Z-Scores based on comparing the patient to an age-matched relevant reference group based on elminda's normative database. This presentation expresses the differences between the patient and the reference group.

The BNA™ Reports are intended to be used by clinicians to enable the evaluation of the patient's brain activity during a specific task compared to an age-range matched reference group.

The system consists of the following components: a computer environment; EEG data input software algorithms for BNA™ calculations; a report generator and a functionality for data transfer and storage.

The device processes and analyzes data received from a dedicated, commercially available, and FDA cleared EEG system, which complies with the BNATM Platform specifications.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Healthy volunteers aged 12-85 years old were recruited. The reference group for AOB tasks includes subjects from 12-85 years across nine age groups. The reference group for VGNG tasks includes subjects from 25-85 years across five age groups. The Resting-EEG reference groups were created with 133 overlapping bins covering the 12-85 age range.
   • Specific numbers of subjects in the test sets (distinct from the normative database mentioned below) for normality and poolability tests are not explicitly stated, but the discussion implies these tests were performed on the Reference-Group Database itself.
   • Data Provenance: Retrospective and prospective. Healthy volunteers were recruited from 13 clinical sites, with 12 sites located within the US. Some volunteers participated at a single visit, while others participated in two successive visits (approximately 1 week apart) for the re-test database, indicating prospective data collection for reliability analysis. The "Reference-Group Database" is inherently a collection of retrospective or prospectively collected data used for comparison.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set in the context of diagnostic accuracy.
   • The study focuses on validating the statistical properties of the normative database (normality, poolability, test-retest reliability). The "ground truth" in this context is the statistical distribution of EEG/ERP scores in a healthy population.

3. Adjudication Method for the Test Set:

   • Not applicable in the traditional sense. The study's focus is on the statistical validation of a normative database rather than diagnostic accuracy against a clinical ground truth requiring adjudication. The "ground truth" is derived from statistical analysis of the healthy volunteer data itself.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. The study focuses on the validation of the device's statistical analysis and normative database, not on comparing human reader performance with and without AI assistance.

5. Standalone Performance (Algorithm Only) Study:

   • A standalone performance study was conducted in the sense that the algorithm's outputs (EEG/ERP scores, Z-scores based on the normative database) were directly evaluated for their statistical properties (normality, poolability, test-retest reliability). This is an "algorithm only" evaluation as it validates the outputs of the BNA™ Platform itself.

6. Type of Ground Truth Used:

   • The ground truth used is based on statistical properties of neurophysiological data from a large cohort of healthy individuals. Specifically, it involves:
     • Normality: Confirmation that EEG/ERP scores conform to a normal distribution within their respective age groups.
     • Poolability: Validation that data across different sites or age segments can be combined appropriately for the normative database.
     • Test-retest reliability: Measurement of the consistency of the device's output over repeated measurements in healthy individuals.
   • This is not a traditional "clinical ground truth" like pathology or outcomes data that would be used to assess diagnostic accuracy against a disease state. Instead, it validates the reference data that the device uses for comparison.

7. Sample Size for the Training Set:

   • The document refers to a "Reference-Group Database" that serves a similar purpose to a training set for creating the normative data against which patient scores are compared.
   • AOB Tasks: 1900 subjects covering age range 12-85 years.
   • Eyes-Closed Resting-State EEG: 1407 subjects covering age range 12-85 years.
   • VGNG Tasks: 1005 subjects covering age range 25-85 years.

8. How the Ground Truth for the Training Set was Established:

   • The "ground truth" (the normative database) for the training set was established through the collection of electrophysiological activity (EEG/ERPs) from a large cohort of healthy volunteers aged 12-85.
   • These volunteers performed specific tasks: Eyes-Closed (EC), Auditory Oddball (AOB), and Visual Go-No-Go (VGNG).
   • The collected data was then compiled to create reference groups, divided into specific age bins for each task. The process of establishing this "ground truth" involved ensuring the statistical validity of the collected data, including the normality testing and poolability analysis as detailed in the acceptance criteria. The BNA™ Platform then compares a patient's data to this established normative database.

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