The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

Device Description

The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.

AI/ML Overview

This 510(k) summary does not contain information related to specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices based on intended use and technological characteristics (like safety compliance, type of system, construction, power source, and computer interface).

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text. The document doesn't include a performance study with detailed acceptance criteria and reported results.

Here's an overview of what is available in the document:

1. A table of acceptance criteria and the reported device performance:

Not Available. The document does not specify performance acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) for measuring eye movements, nor does it present results from a study demonstrating the device meets such criteria. The table in the document compares technological specifications (safety compliance, type, construction, power source, computer interface) of the device against predicate devices, not performance against acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Available. No performance study is described, so no sample size for a test set or data provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Available. No ground truth establishment is described as part of a performance study.

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

Not Available. No adjudication method is described.

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 Nystagmographer (EyeTracker, IDEAS), which measures and displays eye movements. It is not an AI-assisted diagnostic device, and thus, a MRMC study on human reader improvement with AI assistance is not relevant to this type of device.

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

Not Available. While the device works as a standalone measurement system, the document does not describe a formal "standalone performance study" in the context of typical AI/diagnostic device evaluations, with specific metrics and acceptance criteria. It mainly focuses on functional equivalence to predicates.

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

Not Available. No performance study or ground truth definition is provided.

8. The sample size for the training set:

Not Applicable/Not Available. The device is a measurement system, not a machine learning model that requires a training set.

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

Not Applicable/Not Available. As above, no training set is relevant to this device's description.

In summary, the provided 510(k) documentation focuses on substantial equivalence based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and clinical results. For devices like nystagmographs, regulatory clearance often relies more on demonstrating that the device reliably performs its intended measurement function and is safe, similar to existing predicate devices, rather than a clinical efficacy trial with diagnostic accuracy metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the word "DIFRA" next to a circular logo with a line going through the middle. The line has an arrow on each end, with one pointing to the left and the other pointing to the right. The logo and the word "DIFRA" are in black.

510(k) Summary

Submitter Information:

Name and Address:	S.A. INSTRUMENTATION DIFRA
	Rue de l'Eglise 84
	Welkenraedt
	B-4840
	Belgium
	Phone: +32 (87) 89.80.80
	Fax: +32 (87) 89.80.89
	Email: info@difra.be
	www.difra.be
Registration Number:	9710334
Contact Person:	Guido Pagnacco, Ph.D., US Agent
Summary Date:	July 5, 2007

Device Information:

Common/Usual Name: Trade/Proprietary Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

Nystagmographer (video or electrode) EyeTracker, IDEAS 882.1460 Nystagmograph II GWN

K070670

(Premarket Notification [510(k)] Number)

Page 1 of 4

-- DIFRA S.A./N.V.

Roe de l'église, 84 B 4840 WEKENRAD) • 161. 132 (0)67 89 80 80 • Filmeil mitoedra.ne • www.ditabe

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Substantial Equivalency:

The device is substantially equivalent to:

the CHARTR ENG/VNG Diagnostic System (K991497) marketed by ICS 必 Medical Corporation
- the ENGPLUS (K010059) marketed by Western System Research, Inc.
- the VISUAL EYES (K964325) marketed by Micromedical Technologies, Inc.

For its ability to record torsional movements, the device is substantially equivalent to:

the ULMER (VNG) VIDEO NYSTAGMOGRAPH (K982103) marketed by な Synapsys, Inc.
the I-PORTAL, also known as I-PORTAL VNG, part of the NEURO-彩 OTOLOGIC TEST CENTER (K781268) marketed by Neuro Kinetics, Inc.

Description of the device:

Intended use:

The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

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Devicespecifications	EYETRACKER/ IDEAS	CHARTRENG/VNG	ENGPLUS	VISUALEYES	ULMER (VNG)VIDEONYSTAGMOGRAPH	I-PORTAL,(NEURO-OTOLOGICTESTCENTER)
Safetycompliance	EN 60601-1	EN 60601-1	EN 60601-1	EN 60601-1	EN 60601-1	EN 60601-1-2
Type	Video / Electrodebased system	Video /Electrodebased system	Electrode basedsystem	Video basedsystem	Video basedsystem	Video basedsystem
Constructiontype	PC-based systemwith built-inhardware andperipherals	PC-basedsystem withbuilt-inhardware andperipherals	PC-basedsystem withexternalhardwareplatform andperipherals	PC-basedsystem withexternalhardwareplatform andperipherals	PC-based system withbuilt-in hardware andperipherals	PC-basedsystem withexternalhardwareplatform andperipherals
Power source	Mains	Mains	Mains	Mains	Mains	IEEE firewirecable
Computerinterface	Integrated incomputer	Integrated incomputer	Serial or USBconnection	USBconnection	Integrated in computer	IEEE firewirecable

Technological Characteristics:

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Safety:

The device is designed to provide safety to the patient as well as the user and complies with:

- EN 60601-1:1990 Medical Electrical Equipment. Part 1: General requirements for safety
- EN 60601-1-2:2001 Medical Electrical Equipment. Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests

The device is designed, developed and manufactured according to the following standards:

な ISO 9001:2000 Quality Management Systems-Requirements
- ISO13485:2003 Quality management Systems Requirements

The device satisfies all the requirements of the European Community Medical Device Directive MDD 93/42/EEC and bears the CE mark.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, composed of thick, black lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2007

S.A. Instrumentation DIFRA % Vestibular Technologies, LLC Guido Pagnacco. Ph.D. 205 Co. Rd., 128A Suite 200 Cheyenne, WY 82007

Re: K070670

Trade/Device Name: EyeTracker, IDEAS Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: July 5, 2007 Received: July 6, 2007

Dear Dr. Pagnacco:

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

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Page 2 – Guido Pagnacco, Ph.D.

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerelv vours.

Sincerely yours,

Mark A Milliman

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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Indications for Use

510(k) Number (if known): K070670

Device Name: EyeTracker, IDEAS

Indications For Use:

The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)
-------------------------------------------------------	--

Mark M
K070670
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K070670
	Page 1 of ____

Regulation Number and Section

§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).