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ICS Dizcovery is used in the assessment of the vestibular-ocularreflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

The 1091 ICS Dizcovery is used in the assessment of patients with complaints of a vestibular nature such as dizziness, disequilibrium, and vertigo. The ICS Dizcovery type 1091 does not treat or diagnose the patient; the diagnosis is determined by the credentialed physician.

ICS Dizcovery system is intended to be used by qualified medical personnel. Typical device users are Neurologists, Ears, Nose, and Throat specialists (ENTs), Audiologists, Physical Therapists, and Technicians supervised by one of the four mentioned typical users. Professionals with knowledge of diagnosing balance disorders. Users are assumed to have prior knowledge of the medical and scientific facts underlying the procedures offered by the ICS Dizcovery system.

The intended patient population are children in the age of 10 to 18 and adults in age range from 18 to 99 years with a complaint of dizziness, balance disorder, or vestibular disease.

The ICS Dizcovery device is a portable video-oculography (VOG) device. The device shall be indicated for videonystagmography for the assessment of patients with complaints of dizziness, disequilibrium, and vertigo. It provides an assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

The ICS Dizcovery is a wearable measurement system in the form of goggles, with built-in cameras and a motion sensor that simultaneously track eye- and head-movement, respectively. The goggles have two cameras that collect the eye movement video. The goggle device is connected to a PC with Otosuite Vestibular PC software (through a USB cable). The Otosuite Vestibular software functions by processing the binocular camera data collection. The collection of eye movement data is analysed to eye movement in respect to various stimuli throughout testing.

The ICS Dizcovery system is made up of the following components:

• A pair of binocular video goggles for testing, controlled through the Otosuite Vestibular PC software
• Otosuite Vestibular PC software for controlling tests, displaying test data for the various ● tests, reviewing, and printing test results, as well as and managing patients and patient data, users, and test devices.
• A set of Shadeshift® Vision Denied panels; these panels deny the patients vision throughout ● testing whilst allowing the clinician to continue tracking the eyes in darkness. Vision denied testing is needed throughout the test workflow.
• . A set of LCD panels; these automatically shift between dark states to facilitate a userfriendly approach to Skew Deviation testing. This removes the need for manually denying vision of each eye separately with the use of a hand or a paddle.
• A face cushion which inserts into the goggle frame to promote comfort whilst wearing and allow a better fit to face.

Here's a breakdown of the acceptance criteria and study information for the ICS Dizcovery device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for any specific test sets. However, it does refer to "Design Verification & Validation activities" and "Reliability testing... conducted... by a third party." It does not provide information about the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The document mentions that a "credentialled physician will use this data to make a diagnosis," but this refers to the intended use of the device, not the establishment of ground truth for testing.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and technical comparisons.

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

The document implies standalone performance testing as part of the "Software Verification and Validation testing" and "Design Verification & Validation activities." The ICS Dizcovery system "functions by processing the binocular camera data collection. The collection of eye movement data is analysed to eye movement in respect to various stimuli throughout testing." However, the results (e.g., specific metrics for eye movement analysis accuracy) of this standalone algorithm performance are not detailed beyond a general statement of compliance and meeting acceptance criteria.

7. The Type of Ground Truth Used

The document does not explicitly detail the type of ground truth used for specific tests. For the overall validation, it implicitly relies on established engineering and safety standards (e.g., IEC, ANSI) as the "ground truth" against which the device's performance is measured. The "Design Verification & Validation activities" would have involved testing against predefined specifications.

8. The Sample Size for the Training Set

This information is not provided in the document. The text indicates that the device has "software" that processes and analyzes data, implying an algorithm that might have been trained, but no details on training data are given.

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

This information is not provided in the document.

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