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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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I-Portal® Neuro Otologic Test Center (NOTC) is a rotary chair system used in vestibular and neuro-otologic diagnostic testing. The NOTC provides stimuli to a patient through motion profiles and/or visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

l-Portal® Video-Nystagmography System (VNG) is used in vestibular and neuro otologic diagnostic testing. The VNG provides stimuli to a patient through visual cues, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

I-Portal® Video Oculography (VOG) System is used to monitor and record eye movements from various stimuli used in vestibular diagnostic testing. The system measures and records horizontal, vertical, and torsional eve movements, as well as pupil area. It is used in conjunction with various stimuli (rotary chair, manual (done by clinician) positional maneuvers, caloric tests, external stimulus) to detect and record nystagmus and eye tracings for interpretation by qualified medical personnel trained in vestibular diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.

The I-Portal device functions as a nystagmograph, defined by 21 CFR 882.1460 as "a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball." Through its nystagmograph functionality, the device is indicated for use as a diagnostic tool to assist trained physicians in their analysis of vestibular disorders, which requires the separation of central and peripheral nervous system deficits. The I-Portal device is used in an institutional environment on the order of a clinician.

To achieve safe and effective clinical operation, the I-Portal devices use an extensive battery of tests within a family of products: the I-Portal NOTC, the VNG, and the VOG.

The I-Portal NOTC features a rotational chair, the optokinetics (OKN) optical stimulus, the Pursuit Tracker (PT) laser target generator, an I-Portal and VEST software, and a test enclosure equipped with a communication system. Through the use of these elements and the VEST™ analysis software, the physician is able to schedule a set of tests designed to help isolate, identify and understand oculomotor, neurologic and vestibular functions and related possible disorders.

The I-Portal VNG offers a subset of the NOTC tests and different 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. However, unlike the NOTC. it does not have either the rotational chair or the enclosure & communication system, but the VNG can collect and analyze data from caloric and position tests. The VNG configuration is typically used in smaller clinics or conditions requiring a smaller sized device or some mobility.

The third NKI I-Portal configuration is a digital eve tracking system - the I-Portal VOG. The VOG is incorporated within the NOTC and VNG configurations; however, the VOG can be used as a stand-alone product with the VEST and I-Portal software, but offering a subset of the tests afforded by either the NOTC or VNG.

The provided text describes modifications to the I-Portal® Neuro Otologic Test Center (NOTC), I-Portal® Video Nystagmography System (VNG), and I-Portal® Video Oculography Eye Tracking System (VOG) and asserts their substantial equivalence to a previously cleared predicate device (K143607).

However, the document does not contain the detailed acceptance criteria for specific device performance metrics, nor does it present a study that quantifies the device's performance against such criteria. Instead, it focuses on software and hardware modifications and their verification.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states, "The results of the testing met the acceptance criteria and did not identify any new unforeseen risks." However, it does not specify what those acceptance criteria were in terms of quantitative performance (e.g., accuracy, precision, sensitivity, specificity, resolution) for eye tracking, nystagmus detection, or other diagnostic capabilities. It refers to software verification and validation, implying that the acceptance criteria were related to the functionality and safety of the upgraded software and hardware components.

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

Explanation: The document refers to "Verification testing" and "System usability validation (with defined and documented Use Cases)" but does not provide details on the number of subjects, recordings, or cases used in these tests.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Explanation: The document does not describe the specific ground truth establishment process for a test set, as it does not present a clinical performance study with a test set of patient data. The device is a "nystagmograph" that "presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing" and "provides no diagnoses nor does it provide diagnostic recommendations." This implies human experts interpret the device output.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

Explanation: As no detailed clinical performance study with a test set and associated expert review is described, an adjudication method is not mentioned.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not described. The document does not discuss human readers' improvement with or without AI assistance.

Explanation: This type of study would typically be conducted for diagnostic AI algorithms where human interpretation is assisted by the AI. This device is described as a data presentation tool for human interpretation, not an AI diagnostic assistant in the typical sense.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: No, a standalone performance study is not explicitly described.

Explanation: The device is described as a tool that "presents the data for interpretation by qualified medical personnel." It's not an algorithm providing a diagnostic output independently. The performance data section focuses on "Software Verification and Validation Testing" and "Risk Analysis" to ensure the modified components function as intended and do not introduce new risks compared to the predicate device.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated as a single type (e.g., pathology, expert consensus, outcomes data) for a clinical performance study.

Explanation: Given the nature of the device (a nystagmograph providing data for interpretation), the "ground truth" for its verification would likely involve engineering and functional validation against expected physical and optical performance, as well as software functionality tests, rather than a clinical ground truth established by pathology or expert consensus on patient diagnoses. The document mentions "System usability validation (with defined and documented Use Cases)."

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable / Not specified.

Explanation: The document does not describe the development or training of an AI algorithm in the context of machine learning. The improvements mentioned ("Enhanced pupil detection using an auto threshold feature" and "improves video capture") sound more like traditional image processing and software engineering enhancements rather than a machine learning model requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable / Not specified.

Explanation: As no machine learning training process is described, the establishment of ground truth for a training set is not pertinent to this submission.

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