(30 days)
The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.
The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in conjunction with a PC running Compumedics Profusion EEG software. Power is provided by either an internal Lithium-Ion battery or a POE 100BASE-TX network connection. Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety. Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a generalpurpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter. The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number.
The provided text describes a medical device, Okti, which is an Electroencephalograph (EEG) system. The document is a 510(k) premarket notification to the FDA, asserting the substantial equivalence of Okti to a previously cleared predicate device, the Grael EEG system.
While the document extensively covers the electrical, mechanical, and performance specifications of the Okti device and compares it to its predicate, it does not describe a study involving AI assistance, human readers, or the establishment of ground truth by multiple experts for diagnostic performance evaluation, as would be expected for a typical AI/ML-driven device. The device described here is an EEG recording device, not an AI or diagnostic algorithm. Therefore, many of the requested criteria related to AI/ML device performance evaluation (e.g., sample size for test/training sets, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth for diagnostic accuracy) are not applicable or not provided in this specific document.
The "performance data" summary relates to the technical validation of the device's ability to accurately record and process physiological signals, ensuring electrical safety, electromagnetic compatibility, and adherence to established EEG standards. It's about the quality of the signal acquisition, not the diagnostic accuracy of an AI interpreting the signals or a human interpreting with AI assistance.
Based on the provided text, here's what can be extracted regarding acceptance criteria and device performance, focusing on the device's technical performance rather than diagnostic AI performance:
Acceptance Criteria and Reported Device Performance (Technical Validation)
The document focuses on demonstrating substantial equivalence to a predicate device (Grael EEG) by comparing technical, electrical, and physical specifications, and by conducting standard performance and safety tests for EEG acquisition devices.
Table of Acceptance Criteria and Reported Device Performance (Technical Parameters):
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Okti) |
|---|---|---|
| General | Substantial equivalence to predicate (Grael EEG) | All tests passed; results equivalent to Grael. |
| Usage: Intended Use | EEG studies to assist in diagnosis of neurological disorders. | EEG studies to assist in diagnosis of various neurological disorders. |
| Use Environment | Hospital / Clinical use only | Hospital / Clinical use only |
| Temperature | -10°C to 50°C storage/non-operating; 0°C to 40°C operating | -10°C to 50°C storage/non-operating; 0°C to 40°C operating |
| Relative Humidity | 20 to 90% relative humidity non-condensing | 20 to 90% relative humidity non-condensing |
| Altitude | 100 MΩ channels 1-32; > 20 MΩ channels 33-40 (Grael) | > 100 MΩ all channels |
| Bias Current | Typically 1nA | Typically 1nA |
| Input Noise | 100dB | > 100dB |
| Crosstalk |
§ 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).