(63 days)
The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG).
The g.Hlamp is a fully programmable system which provides a total of 256 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The applied part is digitally isolated. The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds in +5V DC. Internally, the +5V DC is further isolated by a dedicated DC/DC type converter.
The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG). It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals. The host computer must use Microsoft Windows 7. g.Hlamp comes a driver and with a C Application Programming Interface (C API) which allows to control the device.
The system consists of the AC/DC adapter (power supply unit), g.HIamp (the amplification and digitization unit), electrode connector boxes with cables to the g.HIamp (to connect EEG electrodes), a USB connector cable to connect the device to a host computer and the driver and C API software.
The g.Hlamp device is a physiological signal amplifier. The provided text describes its 510(k) premarket notification. Here’s an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (g.USBamp K060803) rather than defining specific numerical acceptance criteria for clinical performance. The "acceptance criteria" are implied by comparing the g.Hlamp's technical specifications and intended use against those of the predicate device, as well as by adherence to relevant safety standards.
| Acceptance Criterion (Implied) | Reported Device Performance (g.Hlamp) |
|---|---|
| Safety Standards Adherence: | |
| IEC60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) | Met |
| IEC60601-1-2 (Electromagnetic compatibility) | Met |
| IEC60601-2-25 (Electrocardiographs) | Met (if applicable to ECG acquisition) |
| IEC60601-2-26 (Electroencephalographs) | Met |
| IEC60601-2-40 (Electromyographs and evoked response equipment) | Met (if applicable to EMG acquisition) |
| MDD 93/42/EEC (Medical Device Directive) | Met |
| IEC60601-1-4 (Programmable electrical medical systems) | Met |
| ISO 14971 (Medical devices - Application of risk management to medical devices) | Met |
| IEC 62304 (Medical device software - Software life cycle processes) | Met |
| Functional and Technical Equivalence with Predicate (g.USBamp): | |
| Intended Use | Acquisitions of biopotentials (EEG, EMG, EOG, ECG) and transmission to computer. (Similar to predicate but broader phrasing for g.Hlamp) |
| Full scale input range (±250 mV) | ±250 mV |
| A/D Conversion (24 Bit) | 24 Bit SAR (Predicate is 24 Bit Sigma-Delta; this is a difference but deemed equivalent) |
| Sampling rate (user selectable, up to 38400 Hz/channel) | User selectable (256, ... up to 38400 Hz/channel) (Similar to predicate) |
| CMRR (>90 dB at 60 Hz) | >90 dB at 60 Hz (Predicate is >105 dB, difference noted but deemed acceptable) |
| Noise (100 MOhm) | >100 MOhm |
| Filters (DC up to 2000 Hz) | DC up to 2000 Hz (depending on sampling frequency) |
| Frequency response (Linear between 0.1 and 100 Hz) | Linear between 0.1 and 100 Hz |
| Signal Quality for EEG measurements: | Appropriate signal transmission and amplification for EEG measurements. |
| Accuracy of Impedance Measurements: | Accurate. |
Study Details:
Since the g.Hlamp is a hardware device for acquiring raw biopotential signals (amplifier), and not an AI or diagnostic algorithm, many of the typical study criteria for AI/ML or diagnostic devices do not apply.
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2. Sample size used for the test set and the data provenance:
- Test Set: No patient or clinical data test set was used. The device was tested using an "external signal generator" applying "sinusoidal signals with different frequencies and amplitudes."
- Data Provenance: Not applicable, as testing was done with simulated/generated signals.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth would be the known parameters of the signals generated by the external signal generator. No human experts were involved in establishing this "ground truth."
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human interpretation or adjudication was involved. The performance was assessed by comparing the device's output to the known input signals.
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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. This is an amplifier, not an AI or diagnostic system.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the testing performed was a "standalone" evaluation of the hardware's ability to accurately amplify and transmit signals. The device's performance was measured directly against known input signals from a signal generator.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was established by the known, precisely controlled input signals from an external signal generator. This is a technical ground truth, not a clinical or expert-derived ground truth.
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8. The sample size for the training set:
- Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.
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9. How the ground truth for the training set was established:
- Not applicable.
Summary of the "Study" (Verification and Validation):
The "study" described for the g.Hlamp amplifier is a technical verification and validation process focused on hardware performance and adherence to safety standards, rather than a clinical trial or a study of diagnostic accuracy.
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Methodology:
- Signal Transmission & Amplification: An external signal generator applied sinusoidal signals of varying frequencies and amplitudes to the amplifier inputs. The correctness of signal transmission and amplification was determined using BODE diagrams for each channel.
- Impedance Measurement: Tested using "test impedances."
- Noise: Tested by "short-cutting the input channels."
- Safety: Medical safety was confirmed by evaluating the isolation using digital isolators, DC/DC converters, and a medical power supply unit. The current for impedance measurement was also verified to be limited for safety.
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Conclusion:
- The tests demonstrated "appropriate signal quality for EEG measurements" and "accurate impedance measurements."
- The device "amplify sinusoidal signals with varying frequencies and amplitudes in the same way" as the predicate device and is "working substantial equivalent and as effective as the marketed device."
- It uses "the same key components for medical safety" as the predicate and is therefore considered safe.
In summary, the device met its implied acceptance criteria by showing substantial technical equivalence to its predicate device through rigorous engineering and safety testing, rather than through clinical or AI-specific performance metrics.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).