(232 days)
The Geodesic EEG System 400 Series™ (GES 400) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
The Geodesic EEG System™ 400 Series (GES 400) is a digital electroencephalograph system (EEG). Each system consists of an amplifier, central processing unit, software, electrodes, and components of a standard personal computer (monitor, keyboard, and mouse). The GES 400 Series consists of 3 models (GES 400, GES 405, and GES 410), each of which has a slightly different amplifier. The amplifiers are very similar and all are called Net Amps ". They vary in connectors used to attach the electrodes and in the A/D chips, which support different maximum sampling rates. The other parts of the GES 400 Series are identical and consist of an isolation transformer, a power supply, Net Station software, proprietary EEG electrodes, and data acquisition computer. Optional accessories include a cart that holds the components of the system, interface cable, and articulated arm. The GES 400 Series also accepts third party DIN 42802 electrodes and an SpO22 electrode.
This 510(k) premarket notification for the Geodesic EEG System 400 Series (GES 400) primarily focuses on demonstrating substantial equivalence to its predicate device, the Geodesic EEG System 300 (GES 300), rather than outlining specific acceptance criteria or performing a clinical study to prove the device meets them in the conventional sense of a diagnostic or therapeutic AI/ML device.
The "acceptance criteria" here are implicitly related to the performance characteristics of an EEG system and demonstrating that the new device is as safe and effective as the predicate.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" for the GES 400 series in terms of diagnostic accuracy, sensitivity, or specificity. Instead, the performance is demonstrated through a comparison of technical specifications against a legally marketed predicate device (GES 300). The underlying acceptance criteria are that the new device's technical specifications are comparable or improved without raising new questions of safety or effectiveness.
| Feature | Acceptance Criteria (Implied: Equivalent or better than GES 300) | Reported Device Performance (GES 400 Series) |
|---|---|---|
| General | Intended Use: Measure and record brain electrical activity | Same |
| Patient Population: Adults, children, infants | Same | |
| System Components | CPU: Intel-based | Same (Intel-based) |
| Preferred electrodes: HCGSN | Same (HCGSN) | |
| Other supported EEG electrodes: DIN 42802 | Same (DIN 42802) | |
| Acquisition Software: Net Station (version 4.2 or later) | Net Station 4.5 (Upgrade from 4.2) | |
| Diagnostic software: No | No | |
| Amplifier (Net Amps) | Number of channels: Up to 256 (GES 400/410), Up to 32 (GES 405) | Up to 256 (GES 400/410), Up to 32 (GES 405) |
| A/D conversion: 24 bit | Same (24 bit) | |
| Sampling rate: Up to 20,000 Hz | 8,000 Hz (GES 400/405), 20,000 Hz (GES 410) | |
| Sample and hold: Yes | Same (Yes) | |
| Sensitivity (digitization precision): 0.024 µV/bit | Same (0.024 µV/bit) | |
| Display sensitivity: selectable | Same (selectable) | |
| High and low pass filters: Fully selectable in software | Same (Fully selectable in software) | |
| Notch filter: 50 Hz and 60 Hz in software | Same (50 Hz and 60 Hz in software) | |
| Input impedance: >200 MΩ | >1.0 GΩ (Improved over predicate) | |
| CMRR: >90dB 50/60 Hz | Same (>90dB 50/60 Hz to 90dB 50/60 Hz) | |
| Noise level: 0.7 µV RMS (1.4 µV peak-to-peak) | Same (0.7 µV RMS (1.4 µV peak-to-peak)) | |
| Digital interface: FireWire (predicate) | Ethernet (Upgrade from FireWire) | |
| Processor: Embedded Mindready (predicate) | Embedded Atom processor (Upgrade from Mindready) | |
| Fully software controlled: Yes | Same (Yes) | |
| Power supply: 100-240 VAC, 50/60 Hz, 1.0 A | Same (100-240 VAC, 50/60 Hz, 1.0 A) |
Study Information
The provided document describes a premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies in the same way a novel diagnostic or therapeutic device might.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The submission states, "No animal or clinical testing was submitted." The device's performance is established through technical specification comparison and compliance with electrical safety and EMC standards, not a clinical test set with patient data.
- Data Provenance: Not applicable. The assessment is based on engineering specifications and bench testing for electrical safety and electromagnetic interference.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set requiring expert ground truth was used.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The device is an electroencephalograph, not a diagnostic AI intended to assist human readers in interpreting images or data.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself is a data acquisition system. While it contains software (Net Station 4.5), it does not perform automated diagnoses or interpretations in a "standalone" AI sense. Its primary function is to measure and record electrical brain activity for interpretation by a human clinician. Performance assessment was based on technical specifications and adherence to relevant standards for an electroencephalograph.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. Performance is validated through technical specification equivalence to a predicate device and compliance with electrical safety and EMC standards (UL 60601-1, IEC 60601-1-2, IEC 60601-2-26, CAN/CSA 601.1-M90, and CAN/CSA 60601-2-26). Software verification and validation (EN 62304 and EN 62366) were also conducted.
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The sample size for the training set:
- Not applicable. This device is an EEG system for data acquisition, not a machine learning model that requires a training set in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model was used.
§ 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).