(11 days)
The OmniPro™ System is intended for the measuring, recording and analysis of the electrical activity of a patient's brain through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical setting for EEG/EMG/EOG/ECG/Air Flow/Oximetry.
The OmniAmp is a dual-purpose amplifier system for use in polysomnogram (PSG) and electroencephalogram (EEG) studies in a hospital or diagnostic center. The system hardware consists of an amplifier module with electrode inputs, an interface module and a personal computer (PC) with a data acquisition (DAQ) board. Electrodes and sensors on the patient are connected to the amplifier module, which in turn is connected via a multiconductor cable to an interface box. The interface box is connected via a second multiconductor cable to the DAQ board in the PC, which is used to process display and store the EEG or PSG data. DC power to the amplifier is supplied from the DAQ board through the multiconductor cable. The PC at the patient location is connected to a second PC at a remote monitoring center via modem over the public switched telephone network (PSTN). In EEG studies, the remote PC is used to monitor the waveform data as it is collected by the patient PC to ensure adequate electrode placement and signal quality. At the end of the recorded data is transferred from the patient PC to the remote PC. where it is analyzed and stored.
Here's a breakdown of the acceptance criteria and study information for the OmniPro™ System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the OmniPro™ System does not explicitly state quantitative acceptance criteria in terms of specific performance metrics with target thresholds. Instead, it describes a set of tests to ensure the device meets safety, electromagnetic compatibility, and software design requirements. The "reported device performance" is essentially that the device successfully passed these tests, indicating compliance.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Safety | IEC 60601-1, IEC 60601-2-16 | Successfully conducted to ensure no detrimental effects on patients, other persons, or surroundings. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Emissions) | Successfully conducted to ensure no intolerable magnetic disturbances are introduced. |
| Electromagnetic Immunity | IEC 60601-1-2 (Immunity) | Successfully conducted to ensure satisfactory operation in its electromagnetic environment. |
| Software Functionality | Compliance testing to Software Test Specification | Successfully conducted to ensure the system conforms to all system design requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any clinical or performance test set. The tests mentioned are primarily engineering and compliance tests, not clinical performance studies involving patient data in the way one might typically describe for an AI/CADe device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. Given the nature of the tests described (safety, EMC, software compliance), it's unlikely that "experts to establish ground truth" (in the medical diagnostic sense) were required for these specific tests.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the 510(k) summary. The tests described are compliance-based, not involving expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or described in this 510(k) summary. The OmniPro™ System is an electroencephalograph, not an AI/CADe device that assists human readers in interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This information is not applicable in the context of an electroencephalograph (EEG) system. The OmniPro™ system is a data acquisition and display system for physiological signals, not an algorithm that provides standalone diagnostic interpretations. Its "performance" is related to its technical specifications (e.g., noise, sample rate, filter capabilities) and its ability to accurately acquire and present data, which is demonstrated through engineering tests, not a standalone diagnostic study.
7. The Type of Ground Truth Used
Given the types of tests described (safety, EMC, software functionality), the ground truth for these tests would be defined by:
- Safety standards: The requirements outlined in IEC 60601-1 and IEC 60601-2-16.
- Electromagnetic compatibility standards: The limits and procedures defined in IEC 60601-1-2.
- Software design requirements: The predefined specifications in the Software Test Specification.
There is no mention of medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease presence) because the device's conformity was assessed against engineering and regulatory standards, not diagnostic accuracy.
8. The Sample Size for the Training Set
This information is not applicable/provided in the 510(k) summary. The OmniPro™ System is a hardware and software system for data acquisition and display of EEG/PSG signals. It does not employ machine learning or AI models that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided as the device does not utilize a training set for machine learning.
§ 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).