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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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