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I-Norm 100_18-45 is a quantitative tool for the comparison of patient measurements to a database of known normal subjects ages 18-45. I-Norm 100_18-45 presents data for interpretation by qualified medical personnel trained in vestibular, neurotologic, and neuro-ophtalmic diagnostic testing. I-Norm 100_18-45 is applicable to individuals only in the 18-45 age range.

The proposed intended use for I-Norm 100 18-45 is as following:

I-Norm 100 18-45 is designed to be used with the family of I-Portal® devices:

• I-Portal® Neuro Otologic Test Center (NOTC) (cleared by K083603, K143607)

• I-Portal® Video-Nystagmography System (VNG) SVNG-2 (cleared by K143607)

• I-Portal® Portable Assessment System™ Nystagmograph (I-PAS™) (cleared by K171884)

The I-Portal® devices with I-Norm 100_18-45 are nystagmograph devices intended for use in vestibular and neurotologic diagnostic testing. The addition of the I-Norm 100_18-45 does not change the intended use or the indication for use for these devices from their original clearances listed above.

I-Norm 100_18-45 is a software package that contains normative data for the segment of population ages 18 to 45, for oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests delivered on the family of I-Portal® devices described below.

All I-Portal® devices function as nystagmographs, defined by 21 CFR 882.1460 as "devices used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through their nystagmograph functionality, the I-Portal® devices are indicated for use as a measurement tool to assist trained physicians in their analysis of vestibular and neurotologic disorders, requiring a separation of central and peripheral nervous system deficits. The I-Portal® devices are used in an institutional environment on the order of a physician.

The I-Portal® NOTC features a rotational chair, optokinetic (OKN) optical stimulus, Pursuit Tracker (PT) laser target generator, I-Portal Video Oculography (VOG), I-Portal® and VEST™ software, and a test enclosure equipped with a communication system.

The I-Portal® VNG offers a subset of the NOTC tests and additional vestibular tests through a device with a smaller physical footprint. The VNG has many of the same elements used in the NOTC configuration: OKN optical stimulus, PT laser target generator, VOG, I-Portal and VEST™ software platforms.

The I-PAS™ is a portable, compact, 3D, head-mounted display system with integrated eye tracking that offers a set of tests equivalent to the VNG and additional vestibular and oculomotor tests, but with a smaller physical footprint. Stimuli are presented on a high-resolution digital screen (2560 x 1440 pixels) mounted in a virtual reality-like goggle system.

Software: All I-Portal® devices use VEST™ software to deliver a battery of oculomotor, vestibular, reaction time and cognitive (OVRT-C) tests and I-Portal® software to record eye movements and reaction time responses during these tests. The analysis of OVRT-C tests performed by VEST™ software provides the clinician with a number of physiological measurements to aid in the assessment of vestibular and neurotologic disorders. This application seeks to add I-Norm 100_18-45, a normative oculomotor, vestibular, reaction time and cognitive test database for ages 18-45 to the VEST™ software.

This document describes the I-Norm 100_18-45 software, a quantitative tool that compares patient measurements to a database of known normal subjects aged 18-45. It is designed to be used with Neuro Kinetics, Inc.'s I-Portal® devices (NOTC, VNG, I-PAS™).

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the I-Norm 100_18-45 software is the establishment and presentation of a normative oculomotor and vestibular database for ages 18-45 across various tests. The device performance is demonstrated by the calculation of 95% Reference Intervals (RI) with 90% Confidence Intervals (CI) for a wide range of variables across 16 different oculomotor, vestibular, reaction time, and cognitive (OVRT-C) tests.

The document does not explicitly state pre-defined "acceptance criteria" in a numerical target format (e.g., "accuracy > X%"). Instead, the performance is demonstrated by the successful collection, analysis, and presentation of these normative ranges. The implication is that the derived normative ranges themselves, with their associated confidence intervals, represent the "performance" for establishing what is considered "normal" for the target population.

Table 5-2 (pages 8-10 of the input) serves as the primary evidence of the reported device performance, providing the calculated normative ranges. A representative sample from Table 5-2 is shown below to illustrate the type of reported performance:

Representative Performance Data from Table 5-2 (I-Norm 100_18-45)

Note: "n/a" indicates a limit not of clinical interest for that specific variable (e.g., only an upper limit for latency, or only a lower limit for velocities/gains).

The "acceptance criteria" can be implicitly understood as the successful generation of these statistically robust normative ranges, allowing the device to perform its intended function of comparison. The software verification and validation testing mentioned under "Non-Clinical Performance Data" also implies acceptance criteria related to software functionality and display of norms.

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

• Sample Size for Test Set: The study collected data from a total of 466 subjects (males and females).
• Data Provenance:
  • Country of Origin: United States. Subjects were recruited at 3 different sites: the University of Miami, Naval Medical Center San Diego, and Madigan Army Medical Center.
  • Retrospective or Prospective: The data collection described appears to be prospective, as subjects were "recruited" and "tested" with a battery of tests.

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

This study is focused on establishing normative data for a specific age range, not on classifying or diagnosing specific conditions based on expert consensus. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., for disease diagnosis) isn't directly applicable here.

Instead, the "ground truth" for the normative data is derived from a carefully selected healthy population (ages 18-45) that met strict inclusion/exclusion criteria designed to ensure they were free from conditions that could impact oculomotor and vestibular tests. The establishment of this "healthy" ground truth was implicitly overseen by the Institutional Review Boards (IRBs) that approved the protocols and the researchers conducting the study, who are qualified in the field of vestibular, neurotologic, and neuro-ophthalmic diagnostic testing. The specific number and qualifications of these researchers/clinicians supervising data collection and subject selection are not detailed, but the general context implies medical and scientific expertise.

4. Adjudication Method for the Test Set

Since the study aims to establish normative ranges from healthy individuals rather than diagnose conditions requiring interpretation of ambiguous data, an explicit "adjudication method" for the test set (like 2+1 or 3+1 consensus) was not performed or needed. The raw data from the healthy subjects themselves, after passing the exclusion criteria, formed the basis for the normative ranges.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This study's purpose was to establish normative data for the device, not to assess human reader improvement with AI assistance. The I-Norm 100_18-45 provides a quantitative comparison tool, but it does not act as an AI that assists in interpreting complex images or signals in a way that typically necessitates an MRMC study to show human performance improvement. It's a reference database rather than an assistive AI interpretation tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

The device, I-Norm 100_18-45, is a software package that contains normative data. Its "performance" is its ability to accurately store and present these normative ranges and to allow comparison of patient data to these norms. It is not an algorithm that independently diagnoses or makes decisions, but rather a reference tool.

The "standalone performance" is demonstrated by the calculation of the 95% Reference Intervals (RI) and 90% Confidence Intervals (CI) presented in Table 5-2. These numerical values are a direct output of the algorithm's statistical analysis of the collected data, independent of human interpretation for their derivation. The software then displays these values and visually indicates if patient data fall within or outside these norms. The "Software Verification and Validation Testing" also confirms that the software correctly displays these norms as intended.

7. Type of Ground Truth Used

The ground truth used was normative data derived from a large cohort of healthy individuals (ages 18-45) who met specific inclusion/exclusion criteria. This is essentially "healthy population data" as a form of ground truth for establishing what constitutes "normal" ranges for the specific physiological measurements obtained by the I-Portal® devices. There was no "expert consensus" on individual cases of disease, pathology, or outcomes data used to establish this normative ground truth.

8. Sample Size for the Training Set

The document does not explicitly delineate a "training set" and a "test set" in the typical machine learning sense for an AI model that learns a function. Instead, the entire dataset of 466 subjects was used to establish the normative database. This database, once established, acts as the reference for future patient comparisons. In this context, the 466 subjects serve as the data from which the "normative model" (i.e., the reference intervals) was derived.

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

As noted above, there isn't a "training set" in the conventional AI sense. The ground truth for establishing the normative database (which acts as the reference for the device) was established as follows:

• Subject Selection: Healthy individuals aged 18-45 were recruited from the general population, including nonprofessional athletes, civilians, and military service members.
• Inclusion/Exclusion Criteria: Strict criteria approved by IRBs were used to select subjects. Exclusion criteria were focused on conditions/diseases that could impact oculomotor and vestibular tests (e.g., history of brain injury, severe neuropsychiatric disorders, neurodegenerative disorders of hearing and balance, cerebrovascular disorders, certain ear operations, systemic disorders like renal failure, cirrhosis, and pregnancy).
• Data Collection: Participants underwent a battery of oculomotor, vestibular, reaction time, and cognitive (OVRT-C) tests using I-Portal® NOTC or I-PAS™ devices.
• Statistical Analysis: The collected data from these rigorously selected healthy subjects were analyzed using a univariate general linear model to assess the effect of age, gender, and combined age x gender. Non-parametric methods were then used to calculate the 95% (2.5th and 97.5th) reference interval (RI) with 90% confidence interval (CI) for the lower and upper limits of each variable. This statistical derivation from a verified healthy population constitutes the "ground truth" for the normative data.

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