(287 days)
The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare professional. The device is intended for use on all patient populations including pediatric.
The Intelligent Electroencephalogram (iEEG) device acquires and stores electrical activity of the brain and patient data. The iEEG can be used with other FDA cleared devices such as the BraiNet Kit (K043009) and Ives EEG electrode (K062880). The BraiNet Kit consists of the BraiNet Template (electrode cap), and Sub-dermal EEG Needle Electrodes and Cutaneous EEG Electrodes.
The iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software.
The wireless iEEG transmitter module provides an EEG electrode connection, electrode impedance (connection) status indicator(s), a single-user multi-function push button switch that provides power on/off, electrode impedance check. The wireless module is powered by an internal rechargeable energy source.
The AC charger module provides a convenient means to recharge the wireless module's internal energy source when not in use. The device is not intended to be charged when attached to the patient.
The iEEG viewer/recorder software provides, with the aid of host computer hardware and operating system, the ability to collect EEG electrode data from the wireless iEEG transmitter module, view EEG data, and record data to digital file. The iEEG viewer/recorder provides eight signal graphic display of selectable EEG montages (lead/electrode combinations). It also enables subject data entry (Name, DOB, ID number etc.) and control of EEG data recording to digital file.
The Intelligent Electroencephalogram (iEEG) is designed to be capable of usage and storage in hospital, clinic, and emergency room environments. The iEEG transmitter modules communicate with the computer by using Bluetooth wireless technology.
The provided 510(k) summary for the iEEG (Intelligent Electroencephalograph) device does not contain a dedicated section detailing acceptance criteria or the specifics of a study conducted to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific pre-defined acceptance criteria through a clinical study.
The submission primarily lists technological characteristics and benchmarks them against predicate devices. The "Performance Data" section briefly mentions:
"The device was tested to IEC 60601-1-1 for safety and IEC 60601-2 Electromagnetic Compatibility. The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications. The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements. All applicable tests according to the specified standards were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications."
This indicates that various engineering and safety standards were met through bench testing, but these are not the "acceptance criteria" for a clinical performance study in the way implied by the request. There is no clinical study described with a test set, ground truth, or expert review for diagnostic performance.
Therefore, for the points requested by the user, most of the information is not available in the provided text.
Here's a breakdown of what can be inferred or explicitly stated based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory standards and predicate comparison) | Reported Device Performance and Justification |
|---|---|
| Safety and Essential Performance (General) | - "The device was tested to IEC 60601-1-1 for safety and IEC 60601-2 Electromagnetic Compatibility." |
- "The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications."
- "The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements."
- "All applicable tests according to the specified standards were completed and passed."
- "Bench testing was performed and confirms that the device meets design requirements and specifications." |
| Technological Equivalence (Relative to Predicate Devices) | - Channels: 8 (Equivalent to Zoom-100, within range of Trackit) - ADC Resolution: 16 bit (Same as Zoom-100 and Trackit)
- ADC CMRR: >115dB (Slightly better than predicates (>100dB), deemed "comparable performance")
- Input Impedance: 10MOhm (Same as Zoom-100, better than Trackit)
- Electrode Impedance Check: Yes (Same as predicates)
- Wireless Output: Bluetooth 2.4 GHz (Same as predicates)
- Data Format: edf (Equivalent to Trackit)
- Electrode Material: Standard off-shelf electrodes (Same as predicates)
- Battery: Rechargeable Lithium-Polymer (Equivalent to Lithium-Ion in predicates)
- Charger: Yes (Same as predicates)
- Hi Filter Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)
- Low Filter Settings: Ranges listed (Deemed "Same" to predicates)
- 60 Hz Filter: Yes (Same as predicates)
- Gain Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)
- Time Base Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)
- Display Montage: User selectable (Deemed "Same or clinically insignificant differences" to predicates) |
2. Sample size used for the test set and the data provenance
- Not Available. The document describes bench testing against engineering standards and comparison of technical specifications against predicate devices. It does not mention any clinical test set or patient data used to evaluate diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Available. No clinical test set or ground truth establishment based on expert consensus for diagnostic performance is described. The evaluation was based on conformance to engineering standards and comparison of technical specifications.
4. Adjudication method for the test set
- Not Applicable / Not Available. No clinical test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC comparative effectiveness study was not conducted or reported. The iEEG device is described as an "electroencephalograph" intended to acquire and store electrical activity for review by a medical professional, implying it is a data acquisition and display tool, not an AI-assisted diagnostic tool designed to improve human reader performance or automate diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. The device is not an algorithm for standalone diagnostic performance. It is a hardware/software system for acquiring and displaying EEG data for human review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available. For its "performance data," the device primarily refers to meeting engineering and safety standards (IEC 60601 series). For demonstrating substantial equivalence, its technical specifications were compared to those of already cleared predicate devices. There is no mention of a clinical ground truth (like expert consensus, pathology, or outcomes data) being established for evaluating diagnostic accuracy.
8. The sample size for the training set
- Not Applicable / Not Available. This device is an EEG acquisition and display system, not an AI/ML algorithm that requires a "training set" in the context of diagnostic performance. Any internal development or validation would be against technical specifications, not a clinical training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Available. As noted above, there is no mention of a "training set" or corresponding ground truth.
§ 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).