The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD) waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid in the diagnosis of acute encephalopathy.

DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for the clinician's decision to pursue further testing. The device is NOT to be used as a stand-alone method in the evaluation or diagnosis of acute encephalopathy.

The intended patient is a hospitalized, awake adult, who is at risk of acute encephalopathy and delirium as decided by the responsible licensed healthcare physician or a medical professional working under the responsibility of a licensed healthcare physician.

The use environment is in hospitals:

· non-sterile environments;

· ICUs, wards, and other patient evaluation locations;

The DeltaScan Monitor is intended to be used in combination with the DeltaScan Patch (K222671) through a proprietary connector design.

The DeltaScan Monitor provides EEG signal acquisition and analysis technology intended for use as an adjunct to clinical judgment. The DeltaScan Monitor provides support in clinical decision-making by providing an assessment for a patient having acute encephalopathy or not, based on a measure of the detected polymorphic delta (PMD) waves in the EEG.

The DeltaScan Monitor consists of a Monitor and a Patch connector. The Patch connector contains the EEG amplifier hardware. The Monitor contains electronics for galvanic isolation to the EEG cable with Patch connector, storage of EEG recording and log files (eMMC memory chip), processing capacity to run software (DeltaScan Monitor Application, or DMA), user interface elements (e.g., screen, keys, recording button), battery (FEY PA-IEC-LNB162Q.R001), and the charging circuitry. EEG data is collected by the DeltaScan Monitor using a DeltaScan Patch. Collected EEG signals are amplified, digitized, and then processed by the software algorithms to provide the user with the DeltaScan Output. The DeltaScan Monitor Application is stand-alone software running on an Embedded Linux OS.

This document describes the acceptance criteria and the study that proves the device (DeltaScan Monitor R2) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 434 patients (195 on ICUs and 239 on wards) fulfilled inclusion, but not exclusion, criteria.
• Data Provenance:
  • Country of Origin: The Netherlands (geographically distinct clinics: 6 ICUs and 15 wards).
  • Retrospective or Prospective: Prospective. The study "DeltaStudy" was designed to evaluate diagnostic performance and repeatability, involving the collection of EEGs with DeltaScan and clinical data on ICUs and wards.

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

• Acute Encephalopathy (EEG reference standard): 3 separate EEG experts. Qualifications are not explicitly detailed beyond being "EEG experts." They visually assessed 4-minutes of EEG data for the presence of polymorphic delta activity.
• Delirium (clinical reference standard): 3 clinical delirium experts. Qualifications are not explicitly detailed beyond being "clinical delirium experts." They assessed clinical data including researcher's interview based on DSM-5 criteria A-C, Electronic Health Record data, and description of patient behavior.

4. Adjudication Method for the Test Set

The ground truth for both acute encephalopathy and delirium was established using consensus (majority vote) among the experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study comparing human readers with and without AI assistance was reported. The study focused on the standalone diagnostic performance of the DeltaScan Monitor in comparison to expert consensus (ground truth).

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The "DeltaScan Output" (binary positive/negative for acute encephalopathy) was determined by the DeltaScan Monitor from EEG recordings, and these outputs were compared against the expert committee's estimated diagnoses for acute encephalopathy and delirium.

7. Type of Ground Truth Used

• Acute Encephalopathy: Expert consensus from 3 EEG experts visually assessing EEG data for polymorphic delta activity.
• Delirium: Expert consensus from 3 clinical delirium experts assessing clinical data and DSM-5 criteria.

8. Sample Size for the Training Set

The document mentions that the DeltaScan was calibrated based on a "previous clinical calibration dataset" from Numan et al., 2019, BJA. This dataset contained 321 EEG recordings. This is the sample size for the calibration dataset, which effectively serves as a training or development set for the algorithm's scoring and thresholding.

9. How the Ground Truth for the Training Set Was Established

For the calibration dataset (Numan et al., 2019, BJA), the ground truth for acute encephalopathy and delirium was established through expert labels. The document states that the calibration dataset contained "321 EEG recordings with expert labels for acute encephalopathy and delirium." This suggests a similar expert review process to the test set, where experts provided their diagnoses to create the ground truth.

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The Neuropsychiatric EEG-Based ADHD Assessment Aid (NEBA®) uses the theta/beta ratio of the EEG measured at electrode CZ on a patient 6-17 years of age combined with a clinician's evaluation to aid in the diagnosis of ADHD.

NEBA should only be used by a clinician as confirmatory support for a completed clinical evaluation or as support for the clinician's decision to pursue further testing following a clinical evaluation. The device is NOT to be used as a stand-alone in the evaluation or diagnosis of ADHD.

The NEBA System consists of the following high-level sub-systems:

1. Compact EEG (CEEG) recording system
2. EEG data archive and communications system (EDACS)
3. NEBA Analysis System (NAS).

The CEEG Recording System is used to acquire EEG data from the patient and consists of a dedicated portable computer and monitor (CEED Computer), EEG amplifier hardware (CEEG Amplifier), and EEG recording software (CEEG Software). EEG data is collected by the CEEG Recording System using FDA cleared electrodes and electroconductive gel. The International 10-20 System is used as a basis for electrode placement. A single recording electrode is placed on the scalp at location CZ, while the ground electrode is placed a location FZ (midline frontal) and linked ears reference. Electrooculography (EOG) is used to monitor eve blinks and gross eve movement.

The EDACS is used to provide secure transmission and storage for training and patient data collected at remote sites and consists of server hardware and software and data storage. Data collected from the CEEG System is securely transmitted via EDACS to secure storage.

The NAS is stand-alone software which takes in EEG data recorded by the CEEG system, processes it, and produces the final NEBA Report. The NAS consists of EEG artifact reduction and review software. EEG Frequency Analysis and theta-beta ratio calculation software, and the NEBA Report Generator software. Trained technicians first use the NAS to perform manual and algorithm-based artifact reduction of the EEG signal. The artifact-reduced EEG data is then processed using frequency spectrum analysis software, which converts the time-domain EEG data into the frequency domain. Calculations are then performed to determine the ratio of the power of the theta band ( (000) Hz). Finally, the results of the theta-beta ratio Hz) to the beta band ( calculations are processed by the NEBA Report Generator to generate the report provided to the clinician.

The high-level NEBA sub-systems form an EEG recording and analysis system that is used to compare an individual's quantified EEG with clinical reference values. NEBA provides clinicians with a specific EEG marker of activity in the form of a power ratio. (b)(4) This ratio is computed by adjusted TBR cutoffs are provided that are specific to the NEBA processing and analysis of EEG.

The NEBA interpretive report is transmitted back to the clinician's office and offers two general possibilities that depend on the combination of the NEBA result with the clinician's initial evaluation:

• Confirmatory support
• Further clinical testing may be needed (possible/probable presence of . complicating conditions)

Specifically, the interpretative reports may consist of the following:

1. Along with a clinical diagnostic evaluation. NAS will separate the patients with ADHD as the primary clinical diagnosis into two groups:
   a. A group receiving confirmatory support for presence of ADHD as primary diagnosis.
   b. A group receiving support for the clinician's decision to pursue further testing with focus on other conditions before proceeding with ADHD as primary diagnosis.
2. Along with a clinical diagnostic evaluation. NAS will separate patients with an uncertain clinical diagnosis regarding ADHD into two groups:
   a. A group receiving support for the clinician's decision to pursue further testing with focus on ADHD.
   b. A group receiving support for the clinician's decision to pursue further testing with focus on other conditions.
3. Negative for ADHD as the primary clinical diagnosis is always solely determined by the clinician; no ADHD primary diagnosis is possible without the clinician's determination of ADHD.

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 Device Performance

Note: The document does not explicitly present a table of acceptance criteria as a set of specific numerical targets that the device must meet to be approved. Instead, it describes general requirements for performance testing and then presents the device's measured performance in clinical studies. The table below synthesizes the performance requirements and the reported results.

Study Details

1. Sample Sizes and Data Provenance

• Test Set Sample Size: 275 subjects in total for diagnostic clinical performance analysis (74 adolescents, 201 children).
• Data Provenance:
  • Country of Origin: United States (13 geographically distinct clinics).
  • Retrospective/Prospective: The study involved a prospective, double-blinded, multi-site, clinical cohort study (Study 1) for data collection, followed by a prospectively planned retrospective review of de-identified patient files (Study 2) to establish ground truth.

2. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 experts formed the multidisciplinary clinical team.
• Qualifications: A clinical psychologist, a neurodevelopmental pediatrician, and a child/adolescent psychiatrist.

3. Adjudication Method for the Test Set

• Adjudication Method: Consensus best estimate diagnosis from the multidisciplinary team.

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

• Was an MRMC study done? Yes, a comparison of "NEBA Interpretation (clinician using NEBA) versus clinician alone" against the clinical reference standard was performed.
• Effect size of human reader improvement with AI vs. without AI assistance: The document states, "the results indicate that NEBA provides additional information beyond the clinician's initial diagnosis, substantiating the use of NEBA." While specific effect sizes (e.g., changes in AUC or sensitivity/specificity for human readers) for "human readers improve with AI vs without AI assistance" are not numerically quantified in the provided text as, for example, a percentage increase in accuracy, the provided tables (Tables 5 and 6) illustrate the classification shifts when NEBA interpretation is integrated with the clinician's initial diagnosis compared to the clinician's diagnosis alone. These tables show how the final NEBA Interpretation (positive/negative) aligns with the BED, whereas the clinician alone might have categorized cases as ADHD, Uncertain, or Other Condition. For example, for adolescents, out of 28 BED=ADHD cases, the clinician alone correctly identified 24 as ADHD, with 3 uncertain and 1 other condition. With NEBA Interpretation, 25 were identified as positive for ADHD, correctly capturing 22 of the 24 identified as ADHD by the clinician and 3 of the uncertain cases. This represents an improvement in certainty and alignment with the BED.

5. Standalone Performance Study

• Was a standalone study done? No, the NEBA system is explicitly stated as "NOT to be used as a stand-alone in the evaluation or diagnosis of ADHD." The performance results presented are for "NEBA Interpretation (NEBA+Clinician's initial diagnosis)."

6. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (Best Estimate Diagnosis - BED) from a multidisciplinary team, based on a comprehensive review of all clinical evaluation data (excluding NEBA results, parent rating scales, and clinician diagnostic conclusions to maintain blinding).

7. Training Set Sample Size

• Training Set Sample Size: The document does not explicitly state the sample size of a specific training set. It mentions that "NEBA cutoffs for analysis were pre-established in a separate study." This implies that data was used to train or determine these cutoffs, but the sample size for this is not provided in detail.

8. How Ground Truth for Training Set was Established

• How Ground Truth for Training Set was Established: The document states "NEBA cutoffs for analysis were pre-established in a separate study." The specific methodology for establishing ground truth within that separate study is not detailed in the provided text.

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