(59 days)
The EEG-1100A is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data, may be used by the clinician in Sleep Disorders, Epilepsies and other related disorders as an aid in diagnosis.
The device is intended for use by medical personnel in any location within a medical facility, laboratory, I list or nursing home or outside of a medical facility under direct supervision of a medical professional.
Common names for the EEG-1100A device include Electroencephalograph (EEG) and Polysomnograph (PSG). Nihon Kohden's, model number EEG-1100A intended to record, measure and display the physiological data required for EEG and sleep studies (Polysomnography or PSG). These data, may be used by the clinician in Sleep Disorders, Epilepsies and other disorders as an aid in diagnosis.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NIHON KOHDEN AMERICA, INC. EEG-1100A EEG/PSG Recorder:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Safety and Standards Compliance | IEC 601-1 subclause 56.3(c) (Electrode Lead Wires and Patient Cables) | "The device complies with IEC 601-1 subclause 56.3(c)..." |
| Electromagnetic Compatibility (EMC) | Not explicitly stated (implied) | "The EEG-1100A was subjected to electromagnetic... testing procedures. These tests verified the operation of the device." |
| Environmental Performance | Not explicitly stated (implied) | "...environmental... testing procedures. These tests verified the operation of the device." |
| General Safety | Not explicitly stated (implied) | "...safety... testing procedures. These tests verified the operation of the device." |
| Performance (Hardware) | Ability to record, measure, and display physiological data | "...performance testing procedures. These tests verified the operation of the device." |
| Software Functionality | Acquiring, processing, displaying, and recording of all functions | "Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly mention a "test set" in the context of clinical data for performance evaluation. The device appears to have undergone engineering and software validation testing, but not a study involving patient data with a defined test set.
- Sample Size: Not applicable/not stated for a clinical test set.
- Data Provenance: Not applicable/not stated for a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a study involving a "test set" of clinical cases where ground truth would need to be established by experts for diagnostic performance evaluation. The "experts" implied are those involved in the engineering validation and software testing of the device itself, rather than medical experts evaluating diagnostic output.
4. Adjudication Method for the Test Set
This is not applicable as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study would typically involve human readers (e.g., clinicians) evaluating cases with and without AI assistance to measure the effect size of AI on their performance. The EEG-1100A is described as a recorder and display device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an EEG/PSG recorder and display system, not an algorithm providing a diagnostic output needing standalone performance evaluation. The "performance" described is the device's ability to accurately record, measure, display, and process physiological data. "Software validation" was done to confirm these functions "performed within specifications." This could be interpreted as a form of standalone performance for the software functions, but not in the context of an AI algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
For the engineering and software validation, the "ground truth" would be the device specifications and functional requirements. For example, software validation confirmed functions "performed within specifications," meaning the expected output (the "ground truth") was met by the observed output. It is not expert consensus, pathology, or outcomes data, as those relate to diagnostic accuracy, which is not the focus of the described testing.
8. The Sample Size for the Training Set
Not applicable. The EEG-1100A is a medical device for recording and displaying physiological data, not an AI/ML model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI/ML model, there is no training set or corresponding ground truth to establish.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).