(201 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Requirements | Verification testing confirmed software requirements were met. (Specific metrics are not provided in this summary.) |
| Hardware Requirements | Verification testing confirmed hardware requirements were met. (Specific metrics are not provided in this summary.) |
| User Interface Operation | Validation testing demonstrated the user interface was operating as intended and users could properly use the I-Portal. (Specific metrics are not provided in this summary.) |
| Safety and Effectiveness of User-Defined Normative Data Input | Validation testing demonstrated users can safely and effectively use the I-Portal with user-defined normative data input. (Specific metrics are not provided in this summary.) |
| Equivalence of crHIT Test to Head Thrust Test (Clinical Performance) | Clinical testing confirmed the equivalence of test outputs between the crHIT test and the head thrust test. |
| Hardware Modifications not impacting Funtionality (for crHIT) | Verification testing confirmed that hardware modifications for crHIT do not impact the core functionality of the I-Portal. |
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.
§ 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).