The VEMR™ Eye Movement Recorder is used to observe or record eye movements on a video monitor or video recording tape respectively. This device consists of: patient eye goggles, a video image splitter/power-supply, a video tape cassette recorder (VCR) video monitor console, and a remote control accessory. There is also a built-in microphone in the eye goggles to provide simultaneous voice recording's on a video recording tape. The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.

AI/ML Overview

The provided document describes the ICS VEMR™ Eye Movement Recorder, a device used to observe and record eye movements. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or efficacy for its intended use.

Instead, the document details:

Substantial Equivalence: The device is deemed substantially equivalent to the House InfraRed/Video Electronystagmograph System.
Description of the Device: Components and basic function.
Intended Use: To record and visually display movements of the eyes including nystagmus.
Technological Similarities and Differences to Predicate Device: A comparison table.
Non-Clinical Tests: These tests focus on safety and electromagnetic compatibility, not clinical performance for its stated intended use.

Therefore, many of the requested sections regarding acceptance criteria and performance studies cannot be filled from the provided text.

Here's an analysis of what can be extracted and what is missing:

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

Acceptance Criteria Category	Specific Criteria (if available)	Reported Device Performance
Safety (Biocompatibility)	MEM Elution Cytotoxicity Test	Meets requirements.
	Primary Skin Irritation Test on Rabbits	Not considered an irritant.
Safety (Electrical)	UL-544/42 (dielectric withstand)	Meets requirements.
	UL-544/46 (leakage current)	Meets requirements.
Safety (Radiation)	Max irradiance (ACGIH TLV)	Approx. 1/270 of recommended TLV.
	Max radiance (ACGIH TLV)	Approx. 1/1700 of recommended TLV.
Electromagnetic Compatibility (EMI)	CISPR 11 B (EN55011) Conducted Emissions	Passed.
	CISPR 11 A (EN55011) Radiated Emissions	Passed.
	Military Standard 461 RE 101 Magnetic Emissions	Passed.
	ENV 50140 (IEC 1000-4-3) Radiated Susceptibility Test	Passed.
	EN 61000-4-2 Electrostatic Discharge Test	Passed.
	EN 61000-4-4 Transient Susceptibility Test	Passed.
	EN 61000-4-5 Surge Immunity Test	Passed.
Clinical Performance (Accuracy/Efficacy for Intended Use)	Not specified or reported.	Not specified or reported.

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

Sample Size for Test Set: Not applicable. The document describes non-clinical safety and electromagnetic compatibility (EMC) tests, not performance studies on human subjects.
Data Provenance: Not applicable for clinical performance. The non-clinical tests were likely conducted in a lab environment (e.g., GLP regulations for cytotoxicity and irritation tests, specific test facilities for EMI).
Retrospective or Prospective: Not applicable.

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 applicable as no clinical performance study with expert-established ground truth is described.

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

Not applicable as no clinical performance study requiring adjudication 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

No MRMC study was done. The device does not perform any analyses or measurements; it is a recorder/viewer.

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

No standalone performance study of an algorithm was done. The device is explicitly stated as a "stand-alone device that only permits viewing of the eyes and recording their movements on video tape. Our device does not perform any analyses or measurements of the images."

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

Not applicable as no clinical performance study requiring ground truth is described.

8. The sample size for the training set

Not applicable as there is no mention of an algorithm or AI that would require a training set.

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

Not applicable as there is no mention of an algorithm or AI.

Conclusion:

The 510(k) submission for the ICS VEMR™ Eye Movement Recorder focuses on demonstrating substantial equivalence to a predicate device and proving safety and electromagnetic compatibility through non-clinical testing. It explicitly states that the device "does not perfom any analyses or measurements of the images," thus negating the need for clinical performance studies related to diagnostic accuracy, a typical requirement for AI/algorithm-driven devices. The acceptance criteria and "study" are primarily related to safety, electrical standards, and EMC, where the device "passed" or "meets the requirements" or "is not considered an irritant," etc.

Summary

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K972631

SEP 2 2 1997

510(k) SUMMARY

Submitted by:	ICS MEDICAL CORPORATION2227 Hammond DriveSchaumburg, IL 60173-3860
Telephone:	(847)-397-2150
Fax:	(847)-397-0666
Contact Person:	Delmar F. Bloem, President
Date Summary Prepared:	July 3, 1997
Trade Name of Device:	ICS VEMRTM Eye Movement Recorder
Common Name:	IR/Video Eye Movement Viewer/Recorder
Classification Name:	Nystagmograph (CFR882.1460)

Substantial Equivalence: The ICS VEMR™ Eye Movement Recorder is substantially equivalent to the one used in the House InfraRed/Video Electronystagmograph System for which the company received their 510(k) approval except that our unit is a stand-alone device that only permits viewing of the eyes and recording their movements on video tape. Our device does not perfom any analyses or measurements of the images.

Description of the Device:

The patient eye goggles are an opaque, facially worn device fitted with tiny video cameras, infrared light emitting diodes (LED's), and a microphone. The diodes

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illuminate the eyes for video cameras that produce video signals. These signals are processed by the image processor that essentially allows for simultaneous viewing the video images of both eyes on the video screen. The microphone allows for recording of voices to help document events recorded on video tape. The remote control accessory provides remote control of the various functions (e.g. play, record etc.) on the VCR/video monitor console.

Intended Use:

This device is used to record and visually display movements of the eyes including nystagmus.

Summary of Technological Similarities and Differences to the Predicate Device:

Item	ICS VEMR	Jedmed House Ir/videoVue Goggle System
Goggles fittedwith IR sensitivevideo cameras.	Yes	Yes
IR Source	IR LEDsPeak Wavelength (λ)= 940 nanometers	IR LEDsPeak Wavelength (λ)= 940 nanometers
Light tighteyegoggles	Yes	Yes
Material in contactwith face	Soft PVC plastic	Foam material(unknown composition)
Image splitter/powersupply interface	Yes	Yes
Built-in microphone	Yes	No
Intended use	Identical for both units
Video recordingcapability	Yes (built-in VCR)	Yes (need optional VCR)

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interface

Both units have an interface that allows for display of both eyes on video monitor and provides the power for the video cameras and the LEDs.

Summary of Non-Clinical Tests:

The plastic portion of the goggle material that is in contact with the skin was subjected to:

1. MEM Elution Cytotoxicity Test (performed according to GLP regulations) The test article does meet the requirements of this test.
1. Primary Skin Irritation Test on Rabbits (performed according to GLP regulations) -Findings: " ... the test article, Sellstrom Gold PVC Goggle; lot Identification: May 7, 1997, is not considered an irritant.

The ICS VEMR™, Video Eye Movement Recorder was subjected to a battery of EMI (Electromagnetic interference) and other electrical tests.

The system passed the requirements of the following standard tests:

CISPR 11 B (EN55011) Conducted Emissions CISPR 11 A (EN55011) Radiated Emissions Military Standard 461 RE 101 Magnetic Emissions ENV 50140 (IEC 1000-4-3) Radiated Susceptibility Test EN 61000-4-2 Electrostatic Discharge Test EN 610 00-4-4 Transient Susceptibility Test EN 61000-4-5 Surge Immunity Test

The VEMR unit, based on above findings, will require the following labeling in the VEMR instruction manual:

Warning - This is a Class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures.

Tests on the VEMR™ performed at ICS Medical demonstrated that this units meets the requirements of UL-544/42 (dielectric withstand) and UL-544/46 (leakage current).

Finally, radiometric measurements of the infrared emitting diodes in the VEMR Goggles were made in order to determine whether the spectral radiance and irradiance is within the Threshold Limit Values (TLV's) recommended by the American Conference of Governmental Industrial Hygienists (ACGIH). We determined that the maximum irradiance of the infrared diodes used in the VEMR goggles is approximately 1/270 of the recommended ACGIH TLV of 10 milliwatts/cm2 .

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Likewise the maximum radiance emitted by the VEMR infrared diodes was shown to be approximately 1/1700 of the recommended ACGIH TLV of TLV of 35.3 watts/cm2 (sr).

Based on the above radiometric findings the infrared energy emitted by the small diodes in the VEMR Goggles is well below the recommended ACGIH TLV guidelines thus posing no threat to the patient's eyes.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging into one, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1997

Mr. Delmar F. Bloem ICS Medical Corporation 2227 Hammond Drive Schaumburg, Illinois 60173-3860

Re: K972631 ICS Medical VEMR Video Eye Movement Recorder Trade Name: Regulatory Class: II Product Code: 84GWN July 11, 1997 Dated: Received: July 14, 1997

Dear Mr. Bloem:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Delmar F. Bloem

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1__of__1

510(k) Number (if known): _ K972631

Device Name: ICS Medical VEMR

Indications For Use:

This device is used to record and visually display movements of the eyes including nystagmus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Gillespie
(Division Sign-Off)

Division of Cardiovascular, Respiratory. and Neurological Devices 510(k) Number J

Prescription Use_X (Per 21 CFR 801.109)

ભાગમાં આવેલા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉ

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

. V

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).