The Synapsys VHIT is a medical device designed to assess the vestibular-ocular-reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements.

Device Description

Synapsys VHT (Video Head Impulse Test) allows to assess the vestibular-ocular-reflex (VOR) by measuring, and analyzing eye and head movements. Synapsys VHT does not require the patient to wear goggles, since it consists of a remote camera placed 90 cm from the subject, framing the subject's eyes and head. The device features real-time eyes detection and tracking, thanks to a built-in infrared illuminator hat lights up the subject. Head displacements are retrieved using algorithms that extract motion data from real time images recorded by the camera.

AI/ML Overview

The provided document is an FDA 510(k) summary for the Inventis Synapsys VHIT device. It details a comparative analysis with a predicate device, ICS Impulse, rather than a standalone study of the Synapsys VHIT's performance against defined acceptance criteria for accuracy or clinical effectiveness. The information is limited regarding the specific details requested about statistical methodology and ground truth establishment for a standalone performance study.

Based on the provided text, here's what can be extracted and inferred regarding the "acceptance criteria" and "study that proves the device meets the acceptance criteria":

General Approach and "Acceptance Criteria"

The study described is a comparative analysis rather than a direct performance assessment against a pre-defined absolute accuracy (e.g., Sensitivity/Specificity targets). The core "acceptance criterion" appears to be the agreement between the Synapsys VHIT and the predicate device (ICS Impulse) in VOR Gain measurements.

Acceptance Criteria for VOR Gain Measurement: The primary criterion for the comparative analysis was that "the average VOR Gain computed by the two devices fell within a confidence interval of ±0.1."

Study Details Related to "Acceptance Criteria" and "Device Performance"

Here's the information organized as requested, with details extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Comparative Study)	Reported Device Performance
Average VOR Gain (Synapsys VHIT) vs. Average VOR Gain (ICS Impulse) difference within a confidence interval of ±0.1.	"The results of the comparative analysis demonstrate that the VOR gain differences fall within the predefined confidence interval of ±0.1."

Note: The document primarily focuses on demonstrating substantial equivalence to a predicate device through VOR gain agreement, not on establishing independent accuracy metrics like sensitivity or specificity against a definitive ground truth of vestibular function.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The document mentions tests on "pathological and nonpathological patients" but does not provide the number of patients or the number of tests performed.
Data Provenance: Not explicitly stated (e.g., country of origin). The study used "pathological and nonpathological patients," implying real patient data. It is a prospective comparison of measurements from two devices on the same subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" in this comparative study is the measurement obtained from the predicate device (ICS Impulse) and consistency in eye/head movement trajectories between the two devices, rather than an independent expert-derived clinical diagnosis.

4. Adjudication method for the test set

This information is not provided. As this was a comparative measurement study rather than a diagnostic performance study where human readers would adjudicate results, an adjudication method in the traditional sense (e.g., for image interpretation) is unlikely to have been applied. The comparison was statistical on the quantitative VOR gain values and qualitative assessment of trajectories.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not performed as described. The device is a diagnostic tool for measuring VOR; it is not an AI-powered image analysis tool that assists human readers in making diagnoses. The study performed a direct comparison of quantitative measurements from two medical devices.

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

Yes, in spirit. The comparison was between the measurements generated by the Synapsys VHIT device (which uses "software algorithms for eye tracking and head pose estimation") and the predicate device. While human operators perform the tests, the analysis of VOR gain is an algorithmic output. The study's focus was on the agreement of the device's algorithmic output with that of the predicate. It did not involve assessing the device's diagnostic performance (e.g., sensitivity/specificity for a specific condition) against an independent clinical ground truth in a standalone manner.

7. The type of ground truth used

The "ground truth" in this study was the measurements provided by the legally marketed predicate device (ICS Impulse). Additionally, the consistency of "trajectories of head and eye movements" observed by both devices served as a secondary form of 'truth' or agreement. This is a common approach for demonstrating substantial equivalence for quantitative measurement devices.

8. The sample size for the training set

Not applicable/Not Provided. The document describes a verification and validation study for a medical device that includes "software algorithms." It does not provide details of an AI/ML model's training set as one might find for a deep learning algorithm. The "software algorithms" mentioned are likely deterministic signal processing or computer vision algorithms for eye and head tracking, rather than a machine learning model that requires a "training set" in the conventional sense of supervised learning. If there was an ML component, the training data details are not disclosed.

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

Not applicable/Not Provided. As mentioned above, the document does not describe a training set for an AI/ML model. Therefore, how its "ground truth" was established is not relevant or not provided.

Summary

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January 3, 2025

Inventis S.r.l. Elena Tormen Quality& Regulatory Manager Corso Stati Uniti 1/3 Padova, 35127 Italy

Re: K242726

Trade/Device Name: Synapsys VHIT Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: Class II Product Code: GWN Dated: December 5, 2024 Received: December 5, 2024

Dear Elena Tormen:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242726

Device Name

Synapsys VHIT

Indications for Use (Describe)

The Synapsys VHIT is a medical device designed to assess the vestibular-ocular-reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements.

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 Prepared on: 2024-12-19 Contact Details 21 CFR 807.92(a)(1) INVENTIS S.r.I. Applicant Name Applicant Address Corso Stati Uniti 1/3 Padova 35127 Italy Applicant Contact Telephone +39 0498962844 Applicant Contact Mrs. Elena Tormen Applicant Contact Email quality@inventis.it Device Name 21 CFR 807.92(a)(2) Synapsys VHIT Device Trade Name Common Name Nystagmograph Classification Name Nystagmograph Regulation Number 882.1460 Product Code(s) GWN Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K151504 ICS Impulse GWN Device Description Summary 21 CFR 807.92(a)(4) Synapsys VHT (Video Head Impulse Test) allows to assess the vestibular-ocular-reflex (VOR) by measuring, and analyzing eye and head movements. Synapsys VHT does not require the patient to wear goggles, since it consists of a remote camera placed 90 cm from the subject, framing the subject's eyes and head. The device features real-time eyes detection and tracking, thanks to a built-in infrared illuminator hat lights up the subject. Head displacements are retrieved using algorithms that extract motion data from real time images recorded by the camera. Intended Use/Indications for Use 21 CFR 807.92(a)(5) The Synapsys VHIT is a medical device designed to assess the vestibular-ocular-reflex (VOR) by measuring, and analyzing eye and head movements. Indications for Use Comparison 21 CFR 807.92(a)(5) The Indications for Use of Synapsys VHIT device and the predicate device (ICS Impulse) are the same. Technological Comparison 21 CFR 807.92(a)(6)

Synapsys VHIT has different technological characteristics from the predicate device. Predicate device Natus ICS Impulse consists of head mount goggles which measure the velocity of the head through an accelerometric sensor, and frame eye movements thanks to an infrared camera mounted on the image of the eye reflected on a

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siver mirror placed in front of the eye itself. The software, running on a PC connected to the Natus ICS Impulse device, performs eye detection on real time images recorded by the camera and combines this data with information coming from the accelerometric sensor. In contrast, Synapsys VHT device consists of an infrared remote-camera that frames the subjects face without the need for gogles, avoiding any contact between patient and device. The device lights up the subject's face, placed 90 cm from the camera, thanks to a built-in infrared illuminator. Synapsys VHT software, running on a PC connected to the device, measures eyes and head velocities using software algorithms for eye tracking and head pose estimation, based on analysis of real time images recorded by the camera. Moreover, while Natus ICS Impulse can track and analyze the right eye only, due to the infrared camera permanently fixed on the right side of the goggle, the Inventis Synapsys VHIT can record and analyze both eyes during lateral head impulses.

Both Synapsys VHIT and Natus ICS Impulse devices enable to perform Video Head Impulse Tests on Laterior and Posterior planes, allowing comprehensive assessment of all six semicircular canals. They also both provide the same clinical metrics, including VOR gain, head peak velocities, and quantitative data on detected covert saccades. Additionally, they display a range of informative graphs, such as an overall VOR Gain summary of the performed examination, time-based head and eye velocity traces for each maneuver, and a Gain vs. Head Peak Velocity graph.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The Synapsys VHT device underwent a comprehensive series of tests for its Verification. These tests included verification of all VHIT software and system requirements within their intended operating environment. The testing covered various aspects, including functionality, performance, usability, safety and security, ensuring that the Synapsys VHT device meets its defined software and system specifications.

The Synapsys VHIT device was further tested and validated according to the following standards:

· IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.

· IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral

Standard: Electromagnetic disturbances Requirements and tests.
· EC 60601-1-6: App. Medical electrical equipments for basic safety and essential performance - Collateral standard: Usability

· IEC 62366-1: Medical devices - Application of usability engineering to medical devices

· IEC 62304: Medical device software Software life cycle processes.
· IEC 82304-1: Health software - Part 1: General requirements for product safety
IEC 62471: Photobiological safety of lamps and devices using lamps
· ISO 14971: Medical devices - Application of risk management to medical devices.
· ISO 15223-1: Graphical symbols used for the labeling of medical devices
· ISO 20417: Medical devices - Information to be supplied by the manufacturer

· ISO 17664-2: Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices

· ANSI ASA S3.45: American National Standard Procedures for Testing Basic Vestibular Function

· IEC 81001-5-1: Health software and health IT systems safety effectiveness and security – Part 5-1: Security – Activities in the product life cycle

· IEC TR 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

In addition to the tests performed for Verification of System and Software requirements of Synapsys VHT device, a comparative analysis of VOR gain measurement has been conducted in Synapsys VHIT and ICS Impulse.

Each device has been used, according to the information reported in their User Manual, to perform a test both on pathological and nonpathological patients.

The primary emphasis of the analysis was to verify that the average VOR Gain computed by the two devices fell within a confidence interval of ±0.1. Secondary to this goal, we examined the trajectories to assess whether similar patterns or behaviors. The results of the comparative analysis demonstrate that the VOR gain differences fall within the predefined confidence interval of ±0.1.

This provides evidence that the devices are equivalent for clinical practice, in both pathological subjects.

Additionally, the consistency observed in the trajectories of head and eye movements during head impulse maneuvers further bolsters the case for their equivalence.

In conclusion, the bench and comparative testing results confirm the substantial equivalence (SE) of the Inventis Synapsys VHT device with the predicate device Natus ICS Impulse.

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).