The VisualEyes 515/ VisualEyes 525 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 tained medical professional to assist in diagnosing vestibular disorders. The target population for VisualEyes 515/525 system is 5 years of age+

Device Description

VisualEyes 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 515/ 525 is replacing the existing Micromedical Technologies Spectrum vestibular testing software system and Interacoustics VN415 and VO425 vestibular testing software (510(k) cleared under K964646 and K072254). The software system will work with the existing Micromedical VisualEyes Goggle and Interacoustics VN415/VO425 Goggle. The goggle hardware is not part of this submission and is still assumed covered by K964646 and K072254. 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 limited number of tests (indicated with a * below).

VNG in general is used to record nystagmus during oculomotor tests such as saccades, pursuit and gaze testing, optokinetics and also calorics.The VisualEyes 515/ 525 software performs the following standard vestibular tests: *Spontaneous Nystagmus, Gaze, Smooth Pursuit, Saccade, Optokinetic, *Positionals, *Dix-Hallpikes and *Caloric tests. These are exactly the same standard tests that are performed in the predicate devices and are described in the ANSI standard (ANSI S3.45-1999, "American National Standard Procedures for Testing Basic Vestibular Function"). There are no difference in any settings or parameters in these default tests in any of the devices. The clinical validation tests showed that each test was performed in exactly the same manner and resulted in similar findings when comparing VE525 to the predicate devices.

AI/ML Overview

The provided text describes the Interacoustics VisualEyes 515/525 system, a video nystagmography (VNG) device, and its substantial equivalence determination to predicate devices. However, it does not contain the specific details required to fully address all aspects of your request, particularly regarding quantitative acceptance criteria, statistical study design, and sample sizes for training and test sets.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Acceptance Criteria and Study Details for VisualEyes 515/525

The provided document describes a substantial equivalence (SE) determination based on a comparison to predicate devices, rather than a clinical trial with predefined quantitative acceptance criteria and a detailed statistical analysis of performance metrics. Therefore, a table of acceptance criteria with reported device performance, a sample size for the test set, detailed ground truth establishment, and MRMC study details cannot be fully constructed from the given text.

The core of the "study" described is a side-by-side comparison to demonstrate the algorithms for detecting and analyzing nystagmus were similar to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are explicitly stated, nor are specific quantitative performance metrics reported for the VisualEyes 515/525. The "acceptance criteria" appear to be based on demonstrating "equivalence" in functionality and results compared to predicate devices.

Acceptance Criterion (Inferred from SE determination)	Reported Device Performance (Inferred)
Similar algorithms for detecting and analyzing nystagmus to predicate devices	"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."
Performance as specified	"All these activities, testing and validation show that VisualEyes 515/ 525 perform as specified and is safe and effective."
No essential or major differences affecting safety and effectiveness compared to predicate devices	"We did not find any essential or major differences between the devices."

2. Sample Size Used for the Test Set and 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."

Sample Size for Test Set: Not explicitly stated. The text refers to "the same patient" in a singular sense, but then mentions "test subjects" in plural. It is unclear how many patients/subjects were included in this comparison.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved simultaneous analysis of "the same patient" with conjugate eye movements. It is a prospective comparison in the sense that data was collected specifically for this validation, but not necessarily a "clinical trial" as commonly understood.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study described is a comparison between devices, not primarily against an independent expert-established ground truth. The implication is that the predicate devices' outputs serve as a reference for equivalence.

4. Adjudication Method for the Test Set

This information is not provided. Given the side-by-side comparison, it's possible the "adjudication" was a direct functional comparison of the outputs, but no formal adjudication method is outlined.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly described. The document focuses on device-to-device equivalence rather than human-reader performance with or without AI assistance. The device assists trained medical professionals, but its impact on human reader improvement or an effect size is not discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The described "performance tests" involving the side-by-side comparison with predicate devices can be considered a form of standalone algorithm evaluation when comparing the output signals and processed data directly. However, the device is explicitly intended to "provide information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders," implying a human-in-the-loop for diagnosis. The study focused on the equivalence of the raw measurements and processed data between the new and predicate devices.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparison in this context appears to be the output of the legally marketed predicate devices (Micromedical Technologies Spectrum and Interacoustics VN415/VO425 systems). The goal was to show that the VisualEyes system produced "similar findings" and "equivalence" to these established devices.

"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..."

8. The Sample Size for the Training Set

This information is not provided. The document makes no mention of a "training set" for the algorithms, which is typical for machine learning-based devices. The algorithms likely rely on established biomechanical models for eye movement rather than a distinct training phase.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), this information is not provided.

Summary of Missing Information:

The provided 510(k) summary is focused on establishing substantial equivalence to previously cleared predicate devices, emphasizing functional and technological similarity. It does not contain the detailed statistical analysis, quantitative performance metrics, and specific study design elements (like explicit sample sizes for testing/training, ground truth establishment by experts, or MRMC studies) that would typically be found in direct performance studies or clinical trials for novel devices or AI/ML-driven diagnostics. The "study" described is a technical comparison rather than a full-fledged clinical validation with predefined endpoints.

Summary

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

December 29, 2015

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

Re: K152112

Trade/Device Name: Visualeyes Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: November 28, 2015 Received: December 2, 2015

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 of medical device-related 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.

Srinivas Nandkumar -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) K152112

Device Name VisualEyes 515 / VisualEyes 525

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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510(K) SUMMARY

VisualEyes 515/ 525

Submitter Information:

Company Name
Address

Phone Fax e-mail Contact Person Interacoustics A/S Audiometer Allé 5500 Middelfart Denmark +45 6371 3555 +45 6371 3522 erni@dgs.com Erik Nielsen, Director, Regulatory & Compliance, July 21 2015

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 VisualEyes 525 Vestibular analysis device Nystagmograph, apparatus, vestibular analysis GWN Neurology Class II (According to 21 CFR 882.1460)

VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM Interacoustics A/S K072254 02/05/2008

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

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VisualEyes 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 515/ 525 is replacing the existing Micromedical Technologies Spectrum vestibular testing software system and Interacoustics VN415 and VO425 vestibular testing software (510(k) cleared under K964646 and K072254). The software system will work with the existing Micromedical VisualEyes Goggle and Interacoustics VN415/VO425 Goggle. The goggle hardware is not part of this submission and is still assumed covered by K964646 and K072254. 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 limited number of tests (indicated with a * below).

VNG in general is used to record nystagmus during oculomotor tests such as saccades, pursuit and gaze testing, optokinetics and also calorics.The VisualEyes 515/ 525 software performs the following standard vestibular tests: *Spontaneous Nystagmus, Gaze, Smooth Pursuit, Saccade, Optokinetic, *Positionals, *Dix-Hallpikes and *Caloric tests. These are exactly the same standard tests that are performed in the predicate devices and are described in the ANSI standard (ANSI S3.45-1999, "American National Standard Procedures for Testing Basic Vestibular Function"). There are no difference in any settings or parameters in these default tests in any of the devices. The clinical validation tests showed that each test was performed in exactly the same manner and resulted in similar findings when comparing VE525 to the predicate devices.

Indications for Use The VisualEyes 515/ VisualEyes 525 system provides information to assistin the nystagmographic evaluation, diagnosis and documentation ofvestibular disorders. Nystagmus of the eye is recorded by use of a gogglemounted with cameras. These images are measured, recorded, displayedand stored in the software. This information then can be used by a trainedmedical professional to assist in diagnosing vestibular disorders. Thetarget population for VisualEyes 515/525 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 characteristics software application running on a standard PC.

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Product Comparisons - Indications for use

We have chosen to compare the VisualEyes 515/ 525 software with VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM and VIDEO EYE TRAKKER for the following reasons.

The product is a joint development between Micromedical Technologies and Interacoustics ● to create a mutual software platform for the companies' eye tracking systems
VisualEyes 515/ 525 supports the hardware (goggles) from both systems
. Both predicate systems have previously obtained FDA 510(k) clearance
Both predicate systems have the same medical purpose so it is easy to compare validation results

VN415m, VN415b, VO425m,VO425b	VisualEyes 515/ 525	Discussion
Assist in the Oculographicevaluation, diagnosis anddocumentation of vestibulardisorders.	Assist in thenystagmographicevaluation, diagnosis anddocumentation of vestibulardisorders	The word nystagmographic isused instead of Oculographicas it is currently a moregeneral term in literature
Recorded by use of gogglemounted cameras	Recorded by use of a gogglemounted with cameras	Same
This information then can beused by a trained medicalprofessional to assist indiagnosing vestibular disorders.	This information then canbe used by a trainedmedical professional toassist in diagnosingvestibular disorders.	Same intended operator group
No population age limits	Population limit is 5 years ofage +.	The age limitation (5 years ofage +) has been added as thesystem is not designed forchildren under age 5 as thegoggle does not fit very smallfaces well. We appraise it assimilar indications as it is apractical restriction.

VN415m, VN415b, VO425m, VO425b vs. VisualEyes 515/ 525

We appraise that the indications for use for these two systems are similar as both systems claim:

VIDEO EYE TRAKKER vs. VisualEyes 515/ 525

VIDEO EYE TRAKKER	VisualEyes 515 / 525	Discussion
Routine electronystagmography	Assist in thenystagmographicevaluation, diagnosis anddocumentation of vestibulardisorders	The term"electronystagmography" is notrelevant in this application asvideo is used but "Routinenystagmography" and

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		"nystagmographic evaluation" have equivalence indications
Using miniature video camerasand pupil tracking hardware	Recorded by use of a gogglemounted with cameras	Camera method is identical
No population age limits	Population limit is age 5years of age +.	The age limitation (5 years of age +) has been added as the system is not designed for children under age 5 as the goggle does not fit very small faces well. We appraise it as similar indications as it is a practical restriction.

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.

Clinical tests

We have performed clinical comparisons between the three systems. We have reviewed the literature for articles about vestibular testing. All these activities, testing and validation show that VisualEyes 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 515/ 525 and the predicate devices. We have performed a comparison validation between VisualEyes 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 515/ 525 is substantially equivalent to the marketed predicate devices.

Any deviations between VisualEyes 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).