The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age+

Device Description

VisualEyes 505/515/ 525 is a software program that analyzes eye movements recorded from a camera mounted to a video goggle. A standard Video Nystagmography (VNG) protocol is used for the testing. VisualEyes 505/515/ 525 is and update/change, replacing the existing VisualEyes 515/525 release 1 (510(k) cleared under K152112). The software is intended to run on a Microsoft Windows PC platform. The "525" system is a full featured system (all vestibular tests as listed below) while the "515" system has a subset of the "525″ features. "505″ is a simple video recording mode. The VisualEyes 505/ 515/ 525 software is designed to perform the following vestibular tests: Spontaneous Nystagmus Test, Gaze Test, Smooth Pursuit Test, Saccade Test, Optokinetic Test, Dix-Hallpike, Positional Test, Caloric Test, SHA, Step, Visual VOR, VOR Suppression, Visual Eyes 505. The system consists of a head mounted goggle/mask, a camera unit and a software application running on a standard PC.

AI/ML Overview

The provided text describes a 510(k) submission for the Interacoustics VisualEyes device. The focus of the performance tests is on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria for a novel AI/ML algorithm.

Therefore, many of the typical acceptance criteria and study details relevant to AI/ML device performance (like sensitivity, specificity, AUC, human-in-the-loop performance, expert ground truth establishment for a novel algorithm, etc.) are not explicitly mentioned in this document. The document focuses on showing that the new version of VisualEyes (revision 2) performs similarly to its predecessor (revision 1) and another cleared predicate device (VIDEO EYE TRAKKER).

However, I can extract the relevant information from the provided text as best as possible, interpreting the "acceptance criteria" in this context as the demonstration of substantial equivalence through comparable performance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance for Substantial Equivalence

Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, the "acceptance criteria" can be interpreted as the demonstration that the "key algorithms for detecting and analysing nystagmus" are similar between the new device and the predicate devices. The reported performance is the qualitative finding of "equivalence."

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence: The device's eye movement analysis algorithms (IA Curve tracker) should perform comparably to those in the predicate devices.	"Same – An algorithm comparison evaluation has been performed. This evaluation shows high correlation between the algorithm used in the predicate device and the new as the algorithms are the same." "All results showed equivalence between the predicates and the subject, this means that results processed in predicates are showing equivalence to results from the subject device." "We have performed a comparison validation between VisualEyes 505/515/ 525 and the predicate devices. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the VisualEyes 505/515/ 525 is substantially equivalent to the marketed predicate devices."
Clinical Performance Equivalence: The device should perform as specified, safely and effectively, in clinical comparisons.	"We have performed clinical comparisons between the three systems. These activities, testing and validation show that VisualEyes 505/515/ 525 perform as specified and is safe and effective."
No Essential/Major Differences: No differences should exist that adversely affect safety and effectiveness.	"We did not find any essential or major differences between the devices." "Any deviations between VisualEyes 505/515/ 525 and predicate devices are appraised to have no adverse effect on the safety and effectiveness of the device."

Study Details for Demonstrating Substantial Equivalence

Sample size used for the test set and the data provenance:
- The document states: "The demonstration was carried out as a side by side comparison where the same patient was analysed by the subject device and the predicate device simultaneously."
- It also mentions: "All tests were performed on test subjects with conjugate eye movements."
- However, the exact number of patients/subjects in the test set is not specified.
- Data provenance (country of origin, retrospective/prospective): Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not describe ground truth established by experts in the typical sense for AI/ML performance validation (e.g., for disease diagnosis).
- Instead, the "ground truth" for this substantial equivalence study appears to be the output of the predicate device, as the goal was to show that the new device's processing ("IA Curve Tracker") yielded "high correlation" with and "equivalence" to the predicate device's output. The predicate device itself is implicitly considered the "truth" for comparative purposes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the comparison was directly between the output of the subject device and the predicate device, not against a human-adjudicated ground truth.
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 described. The study focused on the algorithmic comparison between devices, not human reader performance with or without AI assistance. The device's purpose is to assist a trained medical professional, but its performance was validated on the algorithm's output comparison.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this appears to be the primary method of validation for the algorithm. The document states: "One camera recorded the left eye and was processed in the predicate device and the other recorded the right eye and was processed in subject device." This indicates a direct comparison of the algorithmic output, separate from human interpretation or human-in-the-loop performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the algorithmic comparison, the "ground truth" was effectively the output of the predicate device. The study aimed to show that the subject device's processing produced equivalent results to the cleared predicate device for the "key algorithms for detecting and analysing nystagmus."
- For the overall clinical performance, it states "These activities, testing and validation show that VisualEyes 505/515/ 525 perform as specified and is safe and effective," which implies a broader clinical assessment but no specific details on how "truth" was established for clinical outcomes beyond direct comparison to the predicate.
The sample size for the training set:
- Not applicable/Not mentioned. This document describes a 510(k) submission for an update to an existing device, focusing on substantial equivalence tests, not the development or training of a de novo AI/ML model. The algorithm is stated as being "the same" as the predicate's "IA Curve tracker."
How the ground truth for the training set was established:
- Not applicable/Not mentioned for the reasons stated above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 26, 2017

Interacoustics A/S Mr. Erik Nielsen Director, Regulatory & Compliance Audiometer Allé 1 Middelfart 5500 Denmark

Re: K163149

Trade/Device Name: VisualEyes Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: March 24, 2017 Received: March 29, 2017

Dear Mr. Nielsen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163149

Device Name

VisualEyes 515 / VisualEyes 525 / VisualEyes 505

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 05 - 510(k) Summary

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510(K) SUMMARY

VisualEyes 505/515/ 525

Submitter Information:

Company Name
Address

Phone Fax e-mail Contact Person Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark +45 6371 3555 +45 6371 3522 erni@dgs.com Erik Nielsen, Director, Regulatory & Compliance, November 1, 2016

Date Summary Prepared

Device Identification:

Trade Name

Common Name Classification Name Product Code Class Panel Device Class

Predicate Device 1:

Predicate Device Manufacturer 510(k) No. Date Cleared

Predicate Device 2:

Predicate Device Manufacturer 510(k) No. Date Cleared

VisualEyes 515/ 525 Interacoustics A/S K152112 12/29/2015

Vestibular analysis device

Nystagmograph, apparatus, vestibular analysis

Class II (According to 21 CFR 882.1460)

VisualEyes 505 VisualEyes 515 VisualEyes 525

GWN

Neurology

VIDEO EYE TRAKKER Micromedical Technologies Inc. K964646 07/15/1997

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characteristics

VisualEyes 505/515/ 525 is a software program that analyzes eye movements Device Description recorded from a camera mounted to a video goggle. A standard Video Nystagmography (VNG) protocol is used for the testing. VisualEyes 505/515/ 525 is and update/change, replacing the existing VisualEyes 515/525 release 1 (510(k) cleared under K152112). The software is intended to run on a Microsoft Windows PC platform. The "525" system is a full featured system (all vestibular tests as listed below) while the "515" system has a subset of the "525″ features. "505″ is a simple video recording mode. The VisualEyes 505/ 515/ 525 software is designed to perform the following vestibular tests: ● Spontaneous Nystagmus Test (Included in: VisualEyes 525 and 515) Gaze Test (Included in: VisualEyes 525) ● ● Smooth Pursuit Test (Included in: VisualEyes 525) Saccade Test (Included in: VisualEyes 525) ● ● Optokinetic Test (Included in: VisualEyes 525) ● Dix-Hallpike (Included in: VisualEyes 525 and 515) ● Positional Test (Included in: VisualEyes 525 and 515) ● Caloric Test (Included in: VisualEyes 525 and 515) . SHA (Included in: VisualEyes 525 and 515) ● Step (Included in: VisualEyes 525 and 515) ● Visual VOR (Included in: VisualEyes 525 and 515) ● VOR Suppression (Included in: VisualEyes 525 and 515) ● Visual Eyes 505 (included in VisualEyes 505) The VisualEyes system provides information to assist in the Indications for Use nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age+ Intended operator The VisualEyes VNG system is to be used by trained personnel only, such as audiologists, ENT surgeons, doctor's, hearing healthcare professionals or personnel with a similar level of qualifications. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. Technological The system consists of a head mounted goggle/mask, a camera unit and a

software application running on a standard PC.

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We have chosen to compare the VisualEyes 505/ 515/ 525 software with current VisualEyes 515/525 and VIDEO EYE TRAKKER (a.k.a. SPECTRUM) for the following reasons.

VisualEyes 505/ 515/ 525 (VisualEyes revision 2) is an update/change of the VisualEyes ● 515/ 525 (VisualEyes revision 1)
. Video Eye Trakker includes the updated functionality in VisualEyes revision 2 and has been used for rotational chair tests.
. The predicate systems have the same medical purpose so it is easy to compare validation results.
Both predicate systems have previously obtained FDA 510(k) clearance

Comparison table

VisualEyes 505/515/ 525 (revision 2) Versus VisualEyes 515/ 525 (revision 1)

NOTE: In the comparisons table the tests present full system ("525" system).

Description	VisualEyes 515/ 525 (rev 1)	VisualEyes 505/515/ 525 (rev 2)	Equivalence
Indicationsfor use	The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age+	The VisualEyes system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information then can be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes system is 5 years of age+	Same
Test options	Spontaneous Nystagmus Test	Spontaneous Nystagmus Test*	Same.This test is as described inANSI S3.45 section 5
	Gaze Test	Gaze Test	SameThis test is as described inANSI S3.45 section 5
	Smooth Pursuit	Smooth Pursuit	SameThis test is as described inANSI S3.45 section 7

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Description	VisualEyes 515/ 525 (rev 1)	VisualEyes 505/515/ 525 (rev 2) Equivalence
	Saccade Test	Saccade Test	SameThis test is as described inANSI S3.45 section 6
	Optokinetic Test	Optokinetic Test	SameThis test is as described inANSI S3.45 section 8
	Dix-Hallpike	Dix-Hallpike*	SameThis test is as described inANSI S3.45 section 8
	Positional Test	Positional Test*	SameThis test is as described inANSI S3.45 section 8
	Caloric Test	Caloric Test*	SameThis test is as described inANSI S3.45 section 9
	Video recording mode	Video recording mode (VE505)	Same.
	Reporting tools	Reporting tools	Same
Algorithms	IA Curver tracker	IA Curve tracker	Same – An algorithmcomparison evaluationhas been performed. Thisevaluation shows highcorrelation between thealgorithm used in thepredicate device and thenew as the algorithms arethe same
HardwarePlatform	2D-VOG GOGGLES, 2D-VOGSYSTEM	2D-VOG GOGGLES, 2D-VOGSYSTEM	Same

All tests are included in the VisualEyes 525. Tests marked with * is the only tests present in the VisualEyes ਵਰਤ

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Comparison table

VIDEO EYE TRAKKER (K964646) Versus VisualEyes 515/ 525

Note. The VIDEO EYE TRAKKER (K964646) is currently marketed under the name SPECTRUM software for the Micromedical VisualEyes

Description	VIDEO EYE TRAKKER	VisualEyes 515/ 525	Equivalence
Indicationsfor use	The device is used to non-invasivelyrecord horizontal and vertical eyemovements of patients duringroutine electronystagmography(ENG) testing of vestibular functionusing miniature video cameras andpupil tracking hardware.The device is an alternative to skinelectrodes and a physiologic signalamplifier for monitoring eyeposition.	The VisualEyes system providesinformation to assist in thenystagmographic evaluation,diagnosis and documentation ofvestibular disorders. Nystagmusof the eye is recorded by use ofa goggle mounted with cameras.These images are measured,recorded, displayed and storedin the software. This informationthen can be used by a trainedmedical professional to assist indiagnosing vestibular disorders.The target population forVisualEyes system is 5 years ofage+	SimilarSee discussion ofindications for usebelow.
	SHA (Sinusoidal Harmonic Test)	SHA (Sinusoidal Harmonic Test)	SameSee discussion belowthis table
	Step Test	Step Test	SameSee discussion belowthis table
	Visual VOR	Visual VOR	SameSee discussion belowthis table
	Visual Suppression	Visual Suppression	SameSee discussion belowthis table

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Discussion, Similarities in indications for use

Note. This is identical with the discussion in the 510(k) submission for revision 1 of VisualEyes system

VIDEO EYE TRAKKER	VisualEyes	Discussion
Routineelectronystagmography	Assists in thenystagmographicevaluation, diagnosis anddocumentation ofvestibular disorders	The term"electronystagmography"is not relevant in thisapplication as video isused but "Routinenystagmography" and"nystagmographicevaluation" haveequivalence indications
Using miniature videocameras and pupil trackinghardware	Recorded by use of agoggle mounted withcameras	Camera method isidentical
No population age limits	Population limit is ageabove 5 years	The age limitation (5years of age +) has beenadded as the system isnot designed for childrenunder 5 as the goggledoes not fit very smallfaces well. We appraiseit as similar indicationsas it is a practicalrestriction.

VIDEO EYE TRAKKER vs. VisualEyes

Summary of IFU similarities

We appraise that the slightly different phrasing in the indications for use are the only deviation in the comparisons. The deviations are discussed above and appraised to be substantially equivalent and hence do not raise any issues regarding safety and efficiency

Performance Tests

We presented a comparison of the subject device and the predicate devices to demonstrate that the key algorithms for detecting and analysing nystagmus were similar. The demonstration was carried out as a side by side comparison where the same patient was analysed by the subject device and the predicate device simultaneously. All tests were performed on test subjects with conjugate eye movements. This means that an eye movement on one eye will match the movement of the other eye. One camera recorded the left eye and was processed in the predicate device and the other recorded the right eye and was processed in subject device. All results showed equivalence between the predicates and the subject, this means that results processed in predicates are showing equivalence to results from the subject device.

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Clinical tests

We have performed clinical comparisons between the three systems. These activities, testing and validation show that VisualEyes 505/515/ 525 perform as specified and is safe and effective.

Discussion of differences

We did not find any essential or major differences between the devices.

Conclusion

We have compared key issues for the VisualEyes 505/515/ 525 and the predicate devices. We have performed a comparison validation between VisualEyes 505/515/ 525 and the predicate devices. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the VisualEyes 505/515/ 525 is substantially equivalent to the marketed predicate devices.

Any deviations between VisualEyes 505/515/ 525 and predicate devices are appraised to have no adverse effect on the safety and effectiveness of the device.

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).