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The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

g.Nautilus PRO is g.tec's bio-potential amplifier with wireless data transmission technology. The device allows the acquisition of up to 32 EEG (Electroencephalogram) channels with 24 bit resolution. The sampling frequency can be set up to 250 or 500 Hz. g.Nautilus PRO is available with 8-32 channels. The wireless amplifier is transmitting data to a PC or notebook with 2.4 GHz technology. On the computer a receiver unit is connected with USB. Up to 32 analog to digital converters perform the simultaneous sampling. The sampling frequency can be set to 250 Hz or 500 Hz. Each analog to digital converter is operating with 1.024 MHz and performs a 2048 times oversampling for 500 Hz. A sampling frequency of 250 Hz vields to an over-sampling rate of 4096 with a very high signal to noise ratio. Furthermore, the device has an internal impedance check unit. g.Nautilus PRO works with either active gel or active dry electrodes and comes with an EEG cap with chinstrap. The device is controlled via its driver and application programming interface (API), which is part of the g.tec device service g.NEEDaccess. The device is battery supplied. The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. 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 and infants. The host computer must use Microsoft Windows. g.Nautilus PRO comes with a C Application Programming Interface (C API) which allows to control the device. The system consists of the charging device, the g.Nautilus PRO Headset (the amplification and digitization unit with EEG electrodes, cap and chin-strap), the receiver unit (with USB connector cable to connect the device to a host computer), the driver and the C API software. g.Nautilus PRO works in the same manner as the approved and predicate device.

The provided document, K171669, is a 510(k) premarket notification for the g.Nautilus PRO device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study as might be done for a novel or higher-risk device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, ground truth, expert consensus, MRMC studies, or training/test sets is not typically found or required in a 510(k) summary for a physiological signal amplifier unless clinical performance is a new claim or a significant change in the intended use.

The document focuses on demonstrating technical equivalence and safety and effectiveness compared to predicate devices through technical specifications and adherence to standards.

However, I can extract the following information relevant to the device's technical performance and how it meets its intended use, framed within the context of a 510(k) submission:

Device: g.Nautilus PRO (Physiological Signal Amplifier for EEG)

Intended Use (from the document): The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in a 510(k) context for this type of device are primarily compliance with technical specifications comparable to predicate devices and adherence to relevant safety standards. The document doesn't present these as explicit "acceptance criteria" in a table with performance targets for a clinical study, but rather as comparative technical specifications to demonstrate substantial equivalence.

Here's a table comparing the g.Nautilus PRO (This Submission) against its primary predicate device, g.HIamp K123255, based on the "Technological Characteristics" table provided. The "Substantial Equivalence Comments" indicate how the new device's performance is deemed acceptable (i.e., "equivalent in safety and effectiveness") despite differences.

2. Sample size used for the test set and the data provenance

The document describes bench testing rather than a clinical study with a "test set" in the sense of patient data.

• Test Sample: The amplifier itself was tested. The "sample size" is effectively n=1 (the g.Nautilus PRO device).
• Data Provenance: Not applicable as it's not patient data. The testing was performed by applying "sinusoidal signals with different frequencies and amplitudes to the inputs of the amplifier" using an "external signal generator." This suggests laboratory-based, controlled input signals.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a 510(k) focused on technical equivalence and safety standards, not an AI or diagnostic device requiring expert review of output. The "ground truth" for the performance tests was the known characteristics of the input signals from the external signal generator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human adjudication was involved as the test was based on comparing measured electrical signals against known input signals and technical specifications.

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. The device is a physiological signal amplifier, not an AI-assisted diagnostic tool for interpretation of medical images or signals by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "standalone" performance here refers to the device's ability to accurately acquire and transmit EEG signals. The document states:

• "The amplifier was tested with an external signal generator which applies sinusoidal signals with different frequencies and amplitudes to the inputs of the amplifier."
• "The correct signal transmission and amplification was determined with Bode plots for each channel."
• "The impedance measurement was tested with test impedances."
• "Noise was tested by short-cutting the input channels."
• "The tests show that the signal quality is appropriate for EEG measurements and that impedance measurements are accurate."

This constitutes a form of "standalone" functional and performance testing of the hardware.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the technical performance tests, the ground truth was the known, precisely controlled electrical signals generated by an external signal generator and the expected device outputs based on its design specifications.

8. The sample size for the training set

Not applicable. This is a hardware device (physiological signal amplifier) and does not involve machine learning or a "training set" in the context of AI.

9. How the ground truth for the training set was established

Not applicable (as above).

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