(163 days)
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 and above.
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 provided text describes the acceptance criteria and a study to demonstrate the substantial equivalence of the VisualEyes 505/515/525 system to its predicate devices. However, it does not detail specific quantitative acceptance criteria or a traditional statistical study with performance metrics like sensitivity, specificity, or AUC as might be done for an AI/algorithm-only performance study.
Instead, the study aims to show substantial equivalence by verifying that the new software generates the same clinical findings as the predicate devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement thresholds) in the way one might expect for a standalone AI performance evaluation.
Instead, the acceptance criterion for the comparison study was to demonstrate "negligible statistical difference beneath the specified acceptance criteria" between the new VisualEyes software and the predicate devices. The "reported device performance" is simply the conclusion that this criterion was met.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Demonstrate that VisualEyes 505/515/525 produces "negligible statistical difference beneath the specified acceptance criteria" compared to predicate devices for clinical findings. | "all data sets showed a negligible statistical difference beneath the specified acceptance criteria." "There were no differences found in internal bench testing comparisons or the external beta testing statistical comparisons." "all the data between the new VisualEyes software and the data collected and analyzed with both predicate devices are substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated. The document mentions "various groups in different geographical locations externally" for beta testing and that "the same subject" was tested on both the new and predicate devices. However, the exact number of subjects or cases is not provided.
- Data Provenance: Retrospective, as it involved collecting data sequentially from subjects using both the new and predicate devices after the new software was developed. The beta testing was conducted in "external sites that had either MMT or IA existing predicate devices," implying a real-world clinical setting. The geographical locations are described as "different geographical locations externally," implying a multi-site study, but specific countries are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two.
- Qualifications of Experts: "licensed internal clinical audiologists." No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense of multiple readers independently assessing cases and then resolving discrepancies. Instead, the two clinical audiologists reviewed and compared the test results, stating: "It is the professional opinion of both clinical reviewers of the validation that all the data between the new VisualEyes software and the data collected and analyzed with both predicate devices are substantially equivalent." This suggests a consensus-based review rather than a formal adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or performed to measure the improvement of human readers with AI assistance versus without. The study focused on the substantial equivalence of the new software as a device, not on AI-assisted human performance improvement.
6. Standalone (Algorithm-Only) Performance Study
Yes, in a way. The study evaluates the "VisualEyes 505/515/525 software" which is described as a "software program that analyzes eye movements." The comparison is between the output and findings generated by the new software versus the predicate software. While it's part of a system with goggles and cameras, the evaluation focuses on the analytical software component as a standalone entity in its ability to produce equivalent clinical findings.
7. Type of Ground Truth Used
The "ground truth" implicitly referred to here is the "clinical findings" and "test results" generated by the predicate devices. The new software's output was compared to these established predicate device results to determine equivalence. It's a "comparison to predicate" truth rather than an independent gold standard like pathology or long-term outcomes.
8. Sample Size for the Training Set
Not applicable/Not provided. The VisualEyes 505/515/525 is described as an "update/change" and "software program that analyzes eye movements," and "the technological principles for VisualEyes 3 is based on refinements from VisualEyes 2." It's not presented as a machine learning model that undergoes explicit "training" with a separate dataset. It's more of a software update with algorithm refinements.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not provided, as there is no mention of a separate training set or machine learning training process. The software's development likely involved engineering and refinement based on existing knowledge and the performance of previous versions (VisualEyes 2 and the reference devices).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2020
Interacoustics A/S Erik Nielson Director, Regulatory & Compliance Audiometer Alle 1 Middelfart, 5500 Denmark
Re: K200534
Trade/Device Name: VisualEyes Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: July 10, 2020 Received: July 13, 2020
Dear Erik Nielson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Malvina Eydelman, M.D. Office Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K200534
Device Name VisualEyes 515 / VisualEyes 525 / VisualEyes 505
Indications for Use (Describe)
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 and above
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(K) SUMMARY
VisualEyes 505/515/ 525
Submitter Information:
Company Name Address
Phone Fax e-mail Contact Person Date Summary Prepared Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark +45 6371 3555 +45 6371 3522 erni@demant.com Erik Nielsen, Director, Regulatory & Compliance August 07, 2020
Device Identification:
Trade Name
Common Name Classification Name Product Code Class Panel Device Class
Predicate Device: Predicate Device Manufacturer 510(k) No. Date Cleared
Reference devices: Reference Device Manufacturer 510(k) No. Date Cleared
Reference Device Manufacturer 510(k) No. Date Cleared
VisualEyes 505 VisualEyes 515 VisualEyes 525 Vestibular analysis device Nystagmograph, apparatus, vestibular analysis GWN Neurology Class II (According to 21 CFR 882.1460)
VisualEyes 505/515/ 525 Interacoustics A/S K163149 04/26/2017
VIDEO EYE TRAKKER (Aka Spectrum) MicroMedical Technologies Inc K964646 07/15/1997
EyeSeeCam VHIT Interacoustics A/S K131681 09/06/2013
{5}------------------------------------------------
VisualEyes 505/515/ 525 is a software program that analyzes eye Device movements recorded from a camera mounted to a video goggle. A Description 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:
| Test | Availability |
|---|---|
| Calibration | 515 / 525 |
| Spontaneous nystagmus | 515 / 525 |
| Dix-Hallpike | 515 / 525 |
| Positional | 515 / 525 |
| Caloric | 515 / 525 |
| Gaze | 525 |
| Smooth Pursuit | 525 |
| Random Saccade | 525 |
| Saccadometry | 525 |
| Optokinetic | 525 |
| Sinusoidal Harmonic Acceleration | 515/525 |
| Step Velocity | 515/525 |
| VOR Suppression | 515/525 |
| Visual VOR | 515/525 |
| Subjective Visual Vertical (SVV)- Static | 525 |
| Subjective Visual Vertical (SVV)-Dynamic | 525 |
| Video Frenzel | 525 |
| Ocular Counter Roll | 525 |
| VORTEQ AHR | 525 |
| vHIT for VORTEQ | 525 |
| Dynamic Visual Acuity (DVA) | 515/ 525/505 |
| Dix-Hallpike Advanced | |
| Lateral Head Roll | |
| vHIT for EyeSeeCam | |
| - Lateral | |
| - LARP | 515/525/505 |
| - RALP- SHIMP | |
| Video recording | 505 |
{6}------------------------------------------------
| Indications forUse | The VisualEyes system provides information to assist in thenystagmographic evaluation, diagnosis and documentation ofvestibular disorders. Nystagmus of the eye is recorded by use of agoggle mounted with cameras. These images are measured,recorded, displayed and stored in the software. This informationthen can be used by a trained medical professional to assist indiagnosing vestibular disorders. The target population forVisualEyes system is 5 years of age and above. |
|---|---|
| Intendedoperator | The VisualEyes VNG system is to be used by trained personnelonly, such as audiologists, ENT surgeons, doctor's, hearinghealthcare professionals or personnel with a similar level ofqualifications. The device should not be used without the necessaryknowledge and training to understand its use and how results shouldbe interpreted. |
| Technologicalcharacteristics | The VisualEyes is a software system is intended to incorporatevarious goggle/cameras, rotary chairs, irrigators and otheraccessories |
Comparison of technological characteristics with predicate device
We have chosen to compare the VisualEyes 3 software with the VisualEyes 2 as the characteristics of VisualEyes 3 is most similar to VisualEyes 2. The technological principles for VisualEyes 3 is based on refinements from VisualEyes 2 and adoptions of functionality of the two reference devices.
Comparison tables
VisualEyes 3 to Predicate Device VisualEyes 2
| Functionality Description | Equivalence |
|---|---|
| Indications for use:The VisualEyes system provides information toassist in the nystagmographic evaluation, diagnosisand documentation of vestibular disorders.Nystagmus of the eye is recorded by use of agoggle mounted with cameras. These images aremeasured, recorded, displayed and stored in thesoftware. This information then can be used by atrained medical professional to assist in diagnosingvestibular disorders. The target population forVisualEyes system is 5 years of age and above | Same |
| Spontaneous Nystagmus Test | Same |
| Gaze Test | Same |
| Smooth Pursuit Test | Same |
| Saccade Test | Same |
| Optokinetic Test | Same |
| Dix-Hallpike Test | Same |
| Positional Test | Same |
| Caloric Test | Same |
{7}------------------------------------------------
| SHA Test | Same |
|---|---|
| Step Test | Same |
| VOR Suppression Test | Same |
| Saccadometry | This is the same.Saccadometry is a broad term that means saccadiceye movements being measured. The VisualEyessaccade test involves a single stimulus (dot) movingfrom one position to the other. The patient eitherlooks to or away from the dot. There is nodifference in the stimulus presentation between thepredicate and new software. The only difference isthat for the antisaccade the patient looks away fromthe target instead of towards the target. The exactsame measures of latency, accuracy and velocityare recorded and plotted.Since the stimulus presented and the algorithmshave not changed for the saccade tests there areno device safety or effectiveness differencesbetween the two devices. |
| Advanced Dix Hallpike Test | This is the same.For the Advanced Dix Hallpike there are nochanges in how the test is performed. The onlychange was the inclusion of the new torsional eyetracker from Johns Hopkins. This has been verifiedand demonstrates that there are no device safety oreffectiveness differences between the two devices. |
VisualEyes 3 software also adopts functions from the Micromedical Technologies Spectrum software as the Spectrum supports many of the protocols that are being ported into VisualEyes 3.
The VHIT function is adopted into VisualEyes 3 software from EyeSeeCam VHIT
Functionality adopted from reference device VIDEO EYE TRAKKER
| Functionality Description | Equivalence |
|---|---|
| ENG | Same |
| Ocular Counter roll | Uses the Johns Hopkins torsional algorithm not theSpectrum tracking algorithm |
| VORTEQ Active Head Rotation (AHR) | Same |
| VORTEQ Dynamic Visual Acuity (DVA) | Same |
| VORTEQ Video Head Impulse Test (vHIT) | Same |
| Dynamic Subjective Visual Vertical (SVV) inOrion AT chair | Same |
| Static Subjective Visual Vertical in the OrionComprehensive Chair | Same |
| Torsional Tracking Algorithm | This is the same.Improved in release VisualEyes 3 with the additionof libraries from Johns Hopkins. This has beenverified and demonstrates that there are no devicesafety or effectiveness differences between the twodevices. |
{8}------------------------------------------------
| Functionality adopted from reference device EyeSeeCam | |
|---|---|
| Functionality Description | Equivalence |
| vHIT | Same |
Verification and validation summary
In order to validate the new software, bench testing was conducted internally, and beta testing was conducted with various groups in different geographical locations externally. The purpose of the testing is to confirm that the results collected on the updated VisualEyes software generated the same clinical findings as the existing predicate devices.
The beta testing was conducted in external sites that had either MMT or IA existing predicate devices. All data was exported from the external beta sites and transferred to licensed internal clinical audiologists who compared the test results for substantial equivalency. The data was collected sequentially, which involved having the same subject tested on VisualEyes and then tested again on either IA or MMT predicate devices. The data sets were compared to determine if there were any statistically significant differences in the data collected from predicate and current devices.
Summary
There were no differences found in internal bench testing comparisons or the external beta testing statistical comparisons. VisualEyes 505/515/525 performs substantially equivalent to the predicate devices used for the validation.
For the statistical comparison, all data sets showed a negligible statistical difference beneath the specified acceptance criteria.
It is the professional opinion of both clinical reviewers of the validation that all the data between the new VisualEyes software and the data collected and analyzed with both predicate devices are substantially equivalent. There are no differences between any of the products tested.
Conclusion
We have compared key issues for the VisualEyes 505/515/ 525 and the predicate devices. We have performed a comparison validation between VisualEves 505/515/ 525 and the 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.
We trust that the results of these comparisons demonstrate that the VisualEyes 505/515/ 525 is substantially equivalent to the marketed predicate devices (K163149).
§ 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).