(149 days)
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
| Acceptance Criteria (Pre-specified Criteria) | Reported Device Performance (Study Result) | Pass/Fail | Discussion and Sensitivity Analysis | Rationale for Safety and Effectiveness |
|---|---|---|---|---|
| ICU | ||||
| Null hypothesis: NPV |
§ 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.
(a)
Identification. The neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness.
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s).
(6) The device design must include safeguards to prevent use of the device as a stand-alone diagnostic.
(7) The labeling must include the following information:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The qualifications and training requirements for device users including technicians and clinicians.
(iv) The intended use population and the intended use environment.
(v) Any instructions technicians should convey to patients regarding the collection of EEG data.
(vi) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vii) Where appropriate, validated methods and instructions for reprocessing of any reusable components.