The EyeSeeCam vHIT is designed to provide information on the performance of the vestibular ocular reflex (VOR) by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.

Device Description

The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC. The vHIT goggle generally has one camera (monocular) fixed at the top side(s) of the mask. The camera is held in place mechanically with a spherical ball-and-socket joint. The vHIT goggle has support for camera position-for the left and for the right eye. Therefore the camera is interchangeable between the left and right eyes. The vHIT goggle supports the camera that is used to record the eye images. This constitutes the major component of the vHIT system. The USB camera uses infrared light (IR), which is not visible to the naked eye. The IR illumination enables sessions to be performed in complete darkness. The vHIT goggle has dichroic mirrors that allow visible light to pass through and infra red light to be reflected towards the cameras. A calibration laser is placed in the center of the goggle. This is used for camera / pupil calibration before testing. The complete system is operated from a standard PC/Laptop via a standard USB connection. The PC application software controls the camera recordings and shows the results of the tests. EyeSeeCam utilizes an inertial measurement unit (IMU) which is an accelerometer and gyroscope combined. The IMU is contained inside the camera unit. The camera housing is attached to a light weight goggle. The camera records eye movements and the IMU records an electronic waveform that is proportional to head angular velocity (deg/sec).

AI/ML Overview

The EyeSeeCam vHIT is a device intended to objectively measure the vestibular ocular reflex (VOR) in response to head movements specifically for patients experiencing dizziness or balance problems. The submission states that clinical testing compared results between the EyeSeeCam vHIT and a predicate device (VORTEQ/VISUALEYES) and found substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or similar metrics. Instead, "substantial equivalence" to the predicate device, VORTEQ/VISUALEYES, is used as the primary acceptance criterion. The device's performance is demonstrated through this comparison.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device (VORTEQ/VISUALEYES)	"Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device. The results showed compliance and substantial equivalence between the two instruments." and "We have performed a comparison validation between EyeSeeCam and VORTEQ. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the EyeSeeCam vHIT is substantially equivalent to the marketed predicate device."
Functionality (Technical Characteristics)	EyeSeeCam vHIT has similar technology and functionality to the predicate device, with minor differences (e.g., USB vs. Firewire, monocular vs. optional binocular cameras) that are appraised as not having adverse effects on safety and effectiveness.
Compliance with Standards	"Design verification and validation were performed according to current standards for medical device safety and EMC. The device was found in compliance with current standards." This includes IEC 60601-1, ANSI/AAMI ES60601-1, CAN/CSA-C22.2 No. 60601.1:08 for Safety; IEC 60601-1-2 for EMC; and IEC 62471-1, IEC 60825-1 for Laser.

Additional Information:

Sample size used for the test set and the data provenance:
- The document states "Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device," and "We have performed a comparison validation between EyeSeeCam and VORTEQ." However, the specific sample size (number of patients or cases) for this clinical comparison is not provided.
- Data provenance is not specified (e.g., country of origin, retrospective or prospective nature of the clinical study).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. The study primarily relies on a comparison between the EyeSeeCam vHIT and a predicate device.
Adjudication method for the test set:
- The document does not describe any adjudication method for a test set. The comparison is between two devices, not an evaluation against a manually established ground truth using multiple experts.
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, an MRMC comparative effectiveness study was not done. This device is a diagnostic tool for measuring the VOR, not typically categorized as an "AI assistance" tool for human readers in the context of image interpretation. The study focused on device-to-device equivalence.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The EyeSeeCam vHIT operates as a standalone diagnostic device. The clinical comparison study evaluates the performance of the device itself (algorithm only, without human-in-the-loop performance influencing the measurement of VOR, though human interpretation of the results is implied) against another device. So, yes, a standalone performance assessment (in the context of device function) was done by comparing its output to the predicate device.
The type of ground truth used:
- The "ground truth" for the comparison study appears to be the measurements and results obtained from the predicate device (VORTEQ/VISUALEYES), as the study aimed to demonstrate substantial equivalence to this legally marketed device rather than an independent gold standard like pathology or long-term outcomes.
The sample size for the training set:
- The document does not provide information regarding a specific "training set" or its sample size. This submission focuses on the premarket notification for a medical device demonstrating equivalence, which typically does not detail machine learning model training data.
How the ground truth for the training set was established:
- As no information on a training set is provided, how its ground truth would have been established is also not detailed.

Summary

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EyeSeeCam vHIT

Premarket Notification Submission 510(k

510(K) SUMMARY

EyeSeeCam vHIT

Submitter Information: Company Name

Address

Phone
Fax
e-mail
Contact Person

Interacoustics A/S Drejervaenget 8 Assens, DK-5610, Denmark +45 6371 3555 +45 6371 3522 info@interacoustics.com Erik Nielsen, Director, Quality and Regulatory Affairs May 22 2013

SEP 06 2013

Date Summary Prepared

Device Identification:

Trade Name Common Name Classification Name Product Code Panel Device Class

Predicate Devices:

Predicate Device Manufacturer 510(k) No. Date Cleared

EyeSeeCam vHIT Vestibular analysis device Nystagmograph, apparatus, vestibular analysis GWN, LXV Neurology / Ear Nose & Throat Class II (According to 21 CFR 882.1460)

VORTEQ/VISUALEYES Micromedical Technologies K891008 / K964325 05/31/1989 / 07/15/1997

Image /page/0/Picture/16 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe above the word "Interacoustics". The globe is made up of several curved lines that form a sphere. The text is in a bold, sans-serif font.

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Device Description

vHIT is intended to be used as a quick and objective measurement of the vestibular ocular reflex (VOR) in response to head movements in the natural range of daily motions. The results will yield immediate information regarding side-specific vestibular function. EyeSeeCam vHIT allows the healthcare professional to efficiently assess the "dizzy" patient and quickly decide if the dizziness the patient is experiencing is related to a vestibular disorder.

The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC.

The vHIT goggle generally has one camera (monocular) fixed at the top side(s) of the mask. The camera is held in place mechanically with a spherical ball-and-socket joint. The vHIT goggle has support for camera position-for the left and for the right eye. Therefore the camera is interchangeable between the left and right eyes.

The vHIT goggle supports the camera that is used to record the eye images. This constitutes the major component of the vHIT system.

The USB camera uses infrared light (IR), which is not visible to the naked eye. The IR illumination enables sessions to be performed in complete darkness.

The vHIT goggle has dichroic mirrors that allow visible light to pass through and infra red light to be reflected towards the cameras.

A calibration laser is placed in the center of the goggle. This is used for camera / pupil calibration before testing.

The complete system is operated from a standard PC/Laptop via a standard USB connection. The PC application software controls the camera recordings and shows the results of the tests.

EyeSeeCam utilizes an inertial measurement unit (IMU) which is an accelerometer and gyroscope combined. The IMU is contained inside the camera unit. The camera housing is attached to a light weight goggle. The camera records eye movements and the IMU records an electronic waveform that is proportional to head angular velocity (deg/sec).

Image /page/1/Picture/13 description: The image shows the logo for Interacoustics. The logo consists of the word "Interacoustics" in a bold, sans-serif font. Above the word is a symbol that resembles a globe with three horizontal lines running through it. The logo is black and white.

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EyeSeeCam vHIT

Premarket Notification Submission 510(k)

Indications for Use

Intended operator

Technological Characteristics The system is to be used by trained personnel only such as audiologists, ENT surgeons, neurologists, hearing healthcare professionals or personnel with a similar level of education.

The EyeSeeCam vHIT system consists of a head mounted goggle/mask, a camera unit with calibration laser and a software application running on a standard PC.

Image /page/2/Picture/8 description: The image shows a close-up of a phoropter, an instrument used by eye care professionals to determine an individual's refractive error and prescribe corrective lenses. The phoropter is mounted on a stand and positioned in front of a mannequin head. The device features a complex arrangement of lenses, prisms, and other optical components, allowing the examiner to present different lens combinations to the patient. The phoropter is black and the mannequin head is white.

Nonclinical tests summary

Clinical tests

Conclusion

Design verification and validation were performed according to current standards for medical device safety and EMC. The device was found in compliance with current standards

Clinical testing compared test results between the EyeSeeCam vHIT and the Predicate Device. The results showed compliance and substantial equivalence between the two instruments.

We trust that the verification and validation activities show substantial equivalence with the substantial equivalent device and that the EyeSeeCam vHIT is safe and effective for its claimed purpose.

Image /page/2/Picture/16 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe-like symbol above the word "interacoustics" in a bold, sans-serif font. The globe symbol is made up of three horizontal lines intersecting with three vertical lines, creating a symmetrical design. The text is in all lowercase letters and is closely spaced.

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Comparison table

Description	Micromedical TechnologiesVORTEQ /VISUALEYES	EyeSeeCam vHIT	Equivalence
Indications foruse	VORTEQ is designed toprovide information aboutthe Vestibular Ocular Reflex(VOR) in patients withdizziness or balanceproblems	The EyeSeeCam vHIT is designedto provide information on theperformance of the vestibularocular reflex (VOR) by providingobjective measures of eye-velocity response to head-velocity stimulus, showing theVOR gain in the plane of rotationof the head.	SimilarPlease refer to DiscussionSimilarities in indicationsfor usebelow
TechnologyGeneral	VORTEQ utilizes an angularvelocity sensor mounteddirectly to the VisualEyes™FireWire Binocular Goggles.With the VisualEyes™Monocular Goggles, theangular velocity sensor isattached to the back of thegoggle headband forVORTEQ testing. This solidstate sensor produces anelectronic waveform that isproportional to head angularvelocity (deg/sec).	EyeSeeCam utilizes an inertialmeasurement unit (IMU) whichis an accelerometer andgyroscope combined. The IMU iscontained inside the camerahousing. The camera housing isattached to a light weightgoggle. The camera records eyemovements and the IMU recordsan electronic waveform that isproportional to head angularvelocity (deg/sec).	SimilarSee following technicalcomparison and photobelow
TechnologyPhoto	Image: Micromedical Technologies VORTEQ/VISUALEYES	Image: EyeSeeCam vHIT	SimilarSee followingtechnological comparison
Technology(Interface)	Firewire® (IEEE-1394a)	USB	SimilarTwo similarcommunicationprotocols/technologies
Technology(Mono/DualCameras)	Monocular or binocular	Monocular camera,interchangeable between leftand right eyes	SimilarOne or two cameras forVORTEQ while only one
Description	Micromedical TechnologiesVORTEQ /VISUALEYES	EyeSeeCam vHIT	Equivalence
			for EyeSeeCam
Technology(Goggle)	Comfortable fit, Moldedvinyl, fits adult faces only(aprx 400 grams)	Snug fit, Molded cleanablesilicone, Fits pediatric andadult faces(aprx 60 grams)	SimilarBased on description
(Technology)Calibration	Non head-mounted LED(E.g. a Digital Lightbar)	Head mount laser with 5 pointcalibration	SimilarWe ascertain that that thecalibration systems aresubstantially equivalentwith the same purpose toadjust the camerarecordings to the eyepositions. Bothtechnologies measure eyemovements to projecteddot patterns, (MMT uses alight bar and ESC uses alaser on the goggle).
Technology(Sample rate)	250Hz	220Hz	SimilarThe sample rate deviationis appraised not toinfluence themeasurements.
Technology(Head trackingsensor)	Gyroscopes with 6 degreesof freedom	Inertial Measurement Unit (IMU)gyroscope with 6 degrees offreedom	Same
Technology(Gain )	Instantaneous gainmeasured at 45 ms withselectable slide bar tochange to any value, e.g. 40,60, 80 ms	Instantaneous gain at 40, 60,and 80 ms like a scleral coilsearch method	SimilarEyeSeeCam has tree fixedvalues like scleral coilwhile VORTEQ has a rangealso covering the samevalues.
Technology(Data Analysis)	V-Plot, Gain Plot	Velocity Regression Plot, GainPlot	Same
ComplianceStandards	Safety: IEC 60601-1, UL60601, CAN/CSA-C22.2 No.601.1-M90, Class II, Type B,IPXO,EMC: IEC 60601-1-2Laser: IEC 62471-1, IEC60825-1	Safety: IEC60601-1, ANSI/AAMIES60601-1, CAN/CSA-C22.2 No.60601.1:08, Class II, Type B,IPXO,EMC: IEC 60601-1-2Laser: IEC 62471-1, IEC 60825-1	Same

Image /page/3/Picture/4 description: The image shows the logo for Interacoustics. The logo consists of the word "Interacoustics" in a bold, sans-serif font. Above the word is a symbol that resembles a globe with three horizontal lines running through it. The logo is black and white.

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510(k) Summary p. 5

Interacous

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EyeSeeCam vHIT

Discussion, Similarities in indications for use

The vestibulo-ocular reflex (VOR) is a reflex eve movement that stabilizes images on the retina during head movement by producing an eye movement in the direction opposite to head movement, thus preserving the image on the center of the visual field. For example, when the head moves to the right, the eyes move to the left and when the head moves up the eyes move down. The indication for use for EyeSeeCam includes a slightly more detailed description of the same head impulse test procedure used to measure the VOR - including the canal tested is in the direction of the head movement - this includes both vertical and horizontal VOR test described by VORTEQ is certainly capable of testing both horizontal and vertical canals, it just doesn't specify which canals are tested in the intended use statement.

Summary of similarities

We appraise that slightly different technologies have been used in the two products (e.g. USB or Firewire / one or two cameras) but the functionality is ascertained to have the same purpose.

Discussion of differences

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

Verification and validation summary

We have verified EMC, safety and software performance. We have performed clinical comparisons between the EyeSeeCam and VORTEQ. We have reviewed the literature for articles about vestibular testing with vHT. All these activities, testing and validation show that EyeSeeCam vHIT performs as specified and is safe and effective.

Conclusion

We have compared key issues for the EyeSeeCam vHIT and the predicate device VORTEQ. We have performed a comparison validation between EyeSeeCam and VORTEQ. All similarities and differences have been discussed. We trust that the results of these comparisons demonstrate that the EyeSeeCam vHIT is substantially equivalent to the marketed predicate device.

Any deviations between EyeSeeCam vHIT and predicate devices are appraised to have no adverse affect on the safety and effectiveness of the device.

Image /page/5/Picture/14 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe-like symbol above the word "interacoustics" in a bold, sans-serif font. The globe symbol is made up of curved lines that form a spherical shape with horizontal lines running through it. The overall design is simple and modern.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus-like design with three wavy lines.

Public Health Service

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

September 6, 2013

Interacoustics A/S c/o Mr. Erik Nielsen Director. Quality and Regulatory Affairs Drejervaenget 8 Assens, Denmark DK-5610

Re: K131681

Trade/Device Name: EyeSeeCam vHIT Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: June 10, 2013 Received: June 10, 2013

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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Page 2 - Mr. Erik Nielsen

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Applicant: Interacoustics A/S

510(k) Number (if known): K131681

Device Name: EyeSeeCam - vHIT

Indications for Use:

Prescription Use × (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)

Eric A. Mann -S

Page 1 of 1

Image /page/8/Picture/13 description: The image shows the logo for Interacoustics. The logo consists of the word "Interacoustics" in a bold, sans-serif font, with a stylized globe-like symbol above it. The symbol is made up of several curved lines that intersect to form a spherical shape. The logo is black and white.

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).