Search Results
Found 1 results
510(k) Data Aggregation
(39 days)
Measuring, recording and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG.
The g.USBamp is a fully programmable system which provides a total of 16 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The applied part is optically 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.USBamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. 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 XP. g.USBamp comes 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.USBamp (the amplification and digitization unit), a USB connector cable to connect the device to a host computer and the C API.
g.USBamp works in the same manner as the approved and predicate device.
The provided 510(k) summary for the g.USBamp focuses on establishing substantial equivalence to a predicate device (Neuroscan Nuamps K023536) rather than presenting a study to prove the device meets specific acceptance criteria. This type of submission typically relies on comparing performance specifications to the predicate device and demonstrating that the new device is as safe and effective.
Therefore, many of the requested sections about study design, sample sizes, and ground truth are not applicable or cannot be extracted from this document as a formal clinical or standalone performance study in the way one might expect for a diagnostic AI device.
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of formal acceptance criteria for a study, this document performs a technological comparison between the proposed device and the predicate. The "acceptance criteria" here are effectively the performance characteristics of the predicate device that the new device must meet or exceed to demonstrate substantial equivalence.
| Item | Predicate Device (Neuroscan Nuamps K023536) Performance | Proposed Device (g.USBamp) Performance | Substantial Equivalence Demonstrated |
|---|---|---|---|
| Intended Use | Measuring, recording, and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. Patient population: Adults, children and infants. | Measuring, recording and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. | Yes (identical wording) |
| EEG/Polygraphic channels | 40 monopolar | 16 monopolar | Different, but acceptable for intended use (fewer channels) |
| DC channel | 40 | 16 | Different, but acceptable for intended use (fewer channels) |
| Full scale input range | ± 130 mV | ± 250 mV | Improved (wider range) |
| A/D conversion | 22 Bit Sigma-Delta | 24 Bit Sigma-Delta | Improved (higher resolution) |
| Sampling rate | User selectable (125, 250, 500, 1000 Hz/channel) | User selectable (16, 32, 64, 128, 256, ... up to 38400 Hz/channel) | Improved (wider and higher range) |
| CMRR | 100 dB at 60 Hz | >105 dB at 60 Hz | Improved |
| Noise | 0.7 µV RMS, 4 µV peak-to-peak | 80 MOhm | >10^10^ Ohm |
| Filters | DC up to 262 Hz (depending on sampling frequency) | DC up to 2000 Hz (depending on sampling frequency) | Improved (wider range) |
| Frequency response | Linear between 0.1 and 100 Hz | Linear between 0.1 and 100 Hz | Identical |
2. Sample size used for the test set and data provenance
- Sample Size: Not applicable. The "test set" in this context was a series of engineering and performance bench tests using signal generators, not patient data.
- Data Provenance: Not applicable. The testing described involves applying sinusoidal signals with different frequencies and amplitudes to the amplifier inputs. This is a technical performance verification rather than a test with biological data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of expert annotation for clinical data, was not established as the testing involved signal generators and impedance measurements.
4. Adjudication method for the test set
- Not applicable. There was no clinical ground truth requiring expert adjudication.
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
- Not applicable. This device is a physiological signal amplifier, not an AI-powered diagnostic tool requiring a MRMC study for human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was done through bench testing. The amplifier was tested with an external signal generator, and its ability to correctly transmit and amplify signals was determined using BODE diagrams. Impedance measurements were also tested with test impedances. This demonstrates the algorithm's (or hardware's) standalone functionality.
7. The type of ground truth used
- The "ground truth" for the technical performance testing was the known, precisely generated sinusoidal electrical signals from an external signal generator. For impedance measurements, known test impedances were used.
8. The sample size for the training set
- Not applicable. This device, a physiological signal amplifier, does not involve a "training set" in the context of machine learning. Its functionality is based on established electronics and signal processing principles.
9. How the ground truth for the training set was established
- Not applicable for the reason stated above.
Ask a specific question about this device
Page 1 of 1