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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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I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™) is used in vestibular and neuro otologic diagnostic testing. The I-PAS 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 diagnosic testing. This device does not provide diagnoses nor does it provide diagnostic recommendations.

The I-PAS is a head-mounted apparatus enclosing a digital display, infrared lights, dual mirrors, dual cameras, and optical focus knobs. It is attached to the head with straps. The head mounted goggle system displays independent stimuli separately to each eye on a small digital display while simultaneously recording motion from each eye independently with digital video cameras. The system also includes: a computer with Neuro Kinetics' I-Portal and VEST software packages: isolation transformer and connection cables; foot pedals and a hand-held control box with buttons that can be pressed to register motor responses. As with the I-Portal VNG, I-PAS includes the standard battery of VNG tests and can operate in conjunction with caloric test equipment.

The provided text describes the I-Portal® Portable Assessment System™ - Nystagmograph (I-PAS™), a medical device used for vestibular and neuro otologic diagnostic testing. The document is a 510(k) summary, which aims to demonstrate that the I-PAS is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific performance metrics and corresponding reported device performance values. Instead, it describes general compliance and functional equivalence.

The key performance claims are related to:

• Functional Indistinguishability of Visual Cues: The visual cues provided by the I-PAS are functionally indistinguishable from those of the predicate device.
• Safety (No Dizziness): The I-PAS stimuli do not cause dizziness.
• Compliance with Standards: The device complies with ANSI-ASA S3.45-2009 and applicable IEC 60601 standards.
• Intended Performance: Verification and validation testing confirm that the I-PAS performs as intended.

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

The document does not specify the sample size for the clinical test set used to demonstrate functional equivalence or lack of dizziness, nor does it mention the data provenance (country of origin, retrospective/prospective). It only states that "Clinical studies were also run and confirmed..."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any clinical testing. The device itself "presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing," implying that human experts interpret the device's output, but this refers to its intended clinical use, not the validation study ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

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

No MRMC comparative effectiveness study is mentioned. The study focuses on demonstrating the functional equivalence of the I-PAS to its predicate, not on the improvement of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

The I-PAS is a nystagmograph that "monitors the patient's response, and presents the data for interpretation by qualified medical personnel." It explicitly states, "This device does not provide diagnoses nor does it provide diagnostic recommendations." Therefore, it is a data acquisition and presentation device, not an AI algorithm performing diagnostic interpretation. A standalone performance evaluation in the context of an "algorithm only" would not be applicable, as it requires human interpretation of its output.

7. Type of Ground Truth Used:

The type of "ground truth" for the clinical studies mentioned appears to be based on observations and comparisons related to the "functional indistinguishability" of visual cues and the absence of dizziness. This implies that the ground truth was likely established through direct comparison or expert assessment of the visual stimuli and patient comfort/symptoms, rather than comparison to a definitive diagnostic gold standard like pathology or long-term outcomes, as the device itself does not provide diagnoses.

8. Sample Size for the Training Set:

The device is not described as using machine learning or AI in a way that would involve a training set. It's a medical device for acquiring and presenting physiological data. Therefore, the concept of a "training set" is not applicable here.

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

Since there is no mention of a training set for a machine learning algorithm, this question is not applicable.

Summary of Provided Information Regarding Acceptance Criteria and Study:

The document provides a high-level overview of validation activities primarily focused on demonstrating the I-PAS's equivalence to its predicate device and adherence to relevant standards.

• Acceptance Criteria (Implied):
  • Functional indistinguishability of visual cues compared to predicate.
  • Absence of dizziness caused by I-PAS stimuli.
  • Compliance with ANSI-ASA S3.45-2009 and IEC 60601 standards.
  • Proper functioning of the device as intended.
• Reported Performance: "The clinical testing performed confirms that the visual cues are functionally indistinguishable from the predicate, and that I-PAS stimuli do not cause dizziness. Additionally, bench testing confirms that the I-PAS complies with ANSI-ASA S3.45-2009 and verification and validation testing demonstrate that users can safely and effectively use the I-PAS."
• Study Details:
  • Bench tests were performed for verification, validation, and standard compliance.
  • Clinical studies were run to confirm functional equivalence of visual cues and lack of dizziness.
  • No specific sample sizes, expert details, adjudication methods, MRMC studies, or AI training/ground truth information are provided in this summary. The device's function as a data acquisition and presentation tool means many of these AI-specific questions are not applicable.

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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.

I-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 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 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 is used in an institutional environment on the order of a physician.

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

The I-Portal NOTC features a rotational chair, the OKN optical stimulus, the PT laser target generator, the I-Portal VOG, 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 isolating oculomotor and vestibular functions to help the physician understand possible vestibular 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: the OKN optical stimulus, the PT laser target generator, the VOG, and the VEST software platform. However, unlike the NOTC, it does not have the rotational chair, and does not utilize 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 device mobility.

The third configuration of the NKI I-Portal is a digital eye 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 software, but offering a subset of the tests afforded by either the NOTC or VNG.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Testing for crHIT):
  • Sample Size: 22 control subjects and 20 subjects with complaints of dizziness (total 42 subjects).
  • Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection for this specific study. No country of origin is mentioned.

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

• This document does not specify the number or qualifications of experts used to establish a "ground truth" for the clinical testing of crHIT. The comparison is made between the crHIT test and an existing "head thrust test" (a previously cleared predicate device's method), implying the "ground truth" for the clinical performance lies in the accepted interpretation of the outputs from these established tests by qualified medical personnel.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (like 2+1 or 3+1). The study focused on demonstrating the equivalence of test outputs between crHIT and the head thrust test.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. The device is a diagnostic tool that presents data for interpretation by qualified medical personnel, not an AI-assisted diagnostic tool in the sense of directly impacting reader performance metrics.

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

• Yes, the performance data section mentions "Bench tests were executed to verify and validate the I-Portal." This includes verification of software and hardware requirements, and validation that the user interface was operating as intended. While not a pure "AI algorithm only" study in the modern sense (as the device is not solely an AI diagnostic), these bench tests represent standalone performance of the system's underlying functionalities before human interpretation. The device's function is to generate data; the interpretation is always done by a human.

7. The Type of Ground Truth Used

• For the clinical testing of the crHIT feature, the ground truth was based on the outputs of an established, previously cleared predicate device's test (the head thrust test), along with a classification of subjects as "control" or having "complaints of dizziness." The goal was to show equivalence of the new crHIT test outputs to those of the existing method.
• For other aspects (software, hardware, user interface), the ground truth was likely defined by pre-specified requirements and operational definitions verified through testing.

8. The Sample Size for the Training Set

• The document does not mention any "training set." This type of device (nystagmograph for vestibular diagnostic testing) processes real-time or recorded physiological data and presents it to a clinician for interpretation. It does not appear to be an AI/machine learning model that undergoes a training phase with labeled data in the way a typical AI diagnostic would.

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

• As no training set is mentioned or applicable in the context of this device's reported functionality, this question is not relevant.

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