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.

Device Description

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.

AI/ML Overview

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	<0.35 µV RMS, < 2 µV peak-to-peak	Improved (lower noise)
Power Supply	From USB (5V)	External IEC 601-1 mains adapter	Different (external vs. USB power)
Amplifier-PC Interface	USB	USB	Identical
Other Interfaces	Power on LED, 16-letter LCD	Power on LED	Different (no LCD on new device)
Use standard sensors and electrodes	Yes	Yes	Identical
Dimension	198 (L) x 151 (W) x 40 (H) mm	197 (L) x 155 (W) x 40 (H) mm	Comparable
Weight	0.695 kg	1.55 kg	Different (heavier)
Isolation	Optical Signal Isolation	Opto coupler, patient isolation CF type	Comparable (both isolated)
Safety standards	IEC 60601-1, etc.	EN60601-1, etc.	Comparable (meeting relevant medical device safety standards)
System Components	Amplifier/Digitization, USB cable	Amplifier/Digitization, AC/DC Adapter, USB cable	Different (AC/DC adapter included)
Firmware	Resident	Resident	Identical
Digital inputs/outputs	14 inputs, 2 outputs, all patient separated	3 inputs, 2 outputs, all patient separated	Different (fewer inputs)
Stimulation unit input/output	9 pin Sub-D connector	Not available	Different (no stimulation unit)
Patient connection and inputs	40 monopolar inputs - 40 plugs, etc.	16 monopolar inputs - 16 plugs, etc.	Different (fewer inputs)
Type of applied part	BF	CF	Improved (higher degree of patient protection)
Impedance measurement	Performed with 30 Hz	Performed with 20 Hz	Different (frequency)
Input impedance	>80 MOhm	>10^10^ Ohm	Improved (higher impedance)
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.

Summary

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K060803

2 2006 MAY

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

Submitter Information

g.tec medical engineering GmbH Sierningstrasse 14 4521 Schiedlberg Austria

Phone: ++43 (7251) 22240-12 ++43 (7251) 22240-39 Fax:

Contact Person: Christoph Guger

186 December 2005 Date:

807.92(1)(2)

Trade Name: g.USBamp

Common Name: Physiological Signal Amplifier

Classification Names(s): Physiological Signal Amplifier (per 21 CFR section 21 CFR 882.1835)

Classification Number: GWL

807.92(a)(3)

Predicate Device(s)

SAMS AND SERVER SERVER SELLER SERVER SERVE

Neuroscan

Nuamps

K023536

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807.92(a)(4)

Device Description

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.

807.92(1)(5)

Intended Use(s)

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807.92(a)(6)

Technological Characteristics
Item	g.tec medical engineering GmbHg.USBampThis Submission	NeuroscanNuampsK023536
Intended Use	Measuring, recording and analysis ofelectrical activity of the brain and/orthrough the attachment of multipleelectrodes at various locations to aid inmonitoring and diagnosis as routinelyfound in clinical settings for EEG.	The Neuroscan Nuamps is intended forthe measuring, recording and analysis ofthe electrical activity of a patient's brainand/or through the attachment ofmultiple electrodes at various locationsto aid in monitoring and diagnosis asroutinely found in clinical setting forEEG. Patient population: Adults,children and infants.
EEG/Polygraphic channels	16 monopolar	40 monopolar
DC channel	16	40
Full scale input range	$\u00b1$ 250 mV	$\u00b1$ 130 mV
A/D conversion	24 Bit Sigma-Delta	22 Bit Sigma-Delta
Sampling rate	User selectable (16, 32, 64, 128, 256, ...up to 38400 Hz/channel)	Use selectable (125, 250, 500, 1000Hz/channel)
CMRR	>105 dB at 60 Hz	100 dB at 60 Hz
Noise	<0.35 $\u00b5$ V RMS, < 2 $\u00b5$ V peak-to-peak	0.7 $\u00b5$ V RMS, 4 $\u00b5$ V peak-to-peak
Power Supply	External IEC 601-1 mains adapter	From USB (5V)
Internal Storage	N/A	N/A
Amplifier-PC Interface	USB	USB
Other Interfaces	Power on LED	Power on LED,16-letter LCD
Use standard sensors andelectrodes	Yes (electrodes and sensors are notincluded with the amplifier)	Yes (electrodes and sensors are notincluded with the amplifier)
Dimension	197 (L) x 155 (W) x 40 (H) mm	198 (L) x 151 (W) x 40 (H) mm
Weight	1,55 kg	0,695 kg
Isolation	Opto coupler, patient isolation CF type	Optical Signal Isolation
Safety standards	EN60601-1EN60601-1-2EN60601-2-25EN60601-2-26EN60601-2-40MDD 93/42/EECEN60601-1-4EN ISO 14971ANSI/AAMI SW68:2001	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-26EN 46001EN ISO 9001 : 2000MDD 93/42/EECAAMI EC53-1995CDRH Guidance Document on the"Performance Standard of ElectrodeLead Wire and Patient Cables," March 9,1998
System Components	Amplifier/DigitizationAC/DC AdapterUSB cable	Amplifier/DigitizationUSB cable
Firmware	Resident	Resident
Digital inputs/outputs	3 inputs, 2 outputs, all patient separated	14 inputs, 2 outputs, all patient separated
Stimulation unit input/output	Not available	9 pin Sub-D connector
Patient connection and inputs	16 monopolar inputs - 16 plugs4 reference inputs - 4 plugs4 ground inputs - 4 plugsUSB - 1 connectorSYNC IN and SYNC OUT - 2	40 monopolar inputs - 40 plugs2 ground inputs - 2 plugsUSB - 1 plugSync. 1 - 1 plugSync. 2 - 1 plugTrigger port - 9 pin Sub-D
	DIG I/O - 1 connectorSC (short-cut) - 1 connector
Type of applied part	CF	BF
Impedance measurement	Performed with 20 Hz	Performed with 30 Hz
Input impedance	>1010 Ohm	>80 MOhm
Filters	DC up to 2000 Hz (depending onsampling frequency)	DC up to262 Hz (depending on samplingfrequency)
Frequency response	Linear between 0.1 and 100 Hz	Linear between 0.1 and 100 Hz

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807.92(b)(1)

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 are determined with BODE diagrams for each channel. The impedance measurement was tested with test impedances.

807.92(b)(2) Not applicable

807.92(b)(3)

Since g.USBamp and the predicate device amplify sinusoidal signals with varying frequencies and amplitudes in the same way the amplifier is working equivalent to the marketed device.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2006

g.tec medical engineering GmbH c/o TUV Product Service Mr. Stefan Preiss 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K060803

Trade/Device Name: g.USBamp Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: Class II Product Code: GWL Dated: April 11, 2006 Received: April 17, 2006

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Stefan Preiss

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Lerner to

$\gamma$

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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8 Statement of indications for use

510(k) Number (if known):

K060803

Device Name:

g.USBamp

Indications For Use:

Prescription Use X AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Stars of the can and and series and the

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Helent Lemmerd

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K060803

Regulation Number and Section

§ 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).