(97 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.
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:
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined in this document for specific quantitative metrics related to clinical performance. | Not explicitly reported in this document beyond generic statements of "met the acceptance criteria." |
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.
§ 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).