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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.

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.