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The Innovision Audio system is intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.

Innovision Audio is a wireless device intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The Innovision Audio system is intended to be used by healthcare professionals.

Innovision Audio is a multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre).

This document describes the Innovision Audio system, a device intended to provide entertainment and facilitate communication for patients within an MRI scanner environment, and its substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document outlines acceptance criteria as "Pre-defined performance standards" for various tests and confirms that the Innovision Audio device "PASSes" all of them. The reported device performance is explicitly stated for each test.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set in terms of human subjects or distinct MRI scans. The testing summarized is categorized as "Performance Testing - Bench" and "Published Standards Testing." This suggests the tests were primarily laboratory-based, focused on the device's physical and electrical characteristics and its interaction with MRI fields, rather than human trials.

Regarding data provenance, the document does not provide details like country of origin or whether the data was retrospective or prospective. Given the nature of bench testing and compliance with published standards, the data would originate from controlled experimental environments.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the conventional sense of clinical interpretation (e.g., radiologist reads of images). The tests are primarily objective measurements of physical and performance criteria (e.g., temperature rise, SNR, distortion, immunity, usability). Therefore, no specific number or qualification of experts like radiologists is stated as being involved in establishing ground truth for these types of tests. The "ground truth" is defined by the objective pass/fail criteria of the specified standards and performance metrics.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) is mentioned, as the data collection and evaluation appear to be based on objective bench testing against pre-defined performance standards. Such adjudication methods are typically relevant for human reader studies or where subjective interpretation is involved.

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

No MRMC comparative effectiveness study is mentioned. The device is for "entertainment and communication" within the MRI environment and is classified under "Magnetic resonance diagnostic device" (21 CFR 892.1000), but its function, as described, is not directly diagnostic. The testing focuses on its safety and a lack of interference with MRI image quality, not its impact on human diagnostic accuracy. Therefore, a study comparing human readers with and without AI assistance is not applicable to the device's stated function and the provided testing summary.

6. Standalone (Algorithm-Only) Performance:

The Innovision Audio device is a hardware system for entertainment and communication during MRI scans. It is not an algorithm or AI software for image analysis or diagnosis. Therefore, a standalone (algorithm-only) performance evaluation is not relevant or described for this device.

7. Type of Ground Truth Used:

The "ground truth" for the testing conducted (bench and standards testing) is based on objective, pre-defined performance standards and measurable parameters. This is not based on expert consensus, pathology, or outcomes data, as these types of ground truth are typically used for diagnostic or clinical efficacy studies. For example, for "MR safety," the ground truth is that the heating of applied parts must not be greater than 41°C. For "NEMA MS" tests, the ground truth relates to the device having "no appreciable effect" on image quality parameters like SNR, signal uniformity, and geometric distortion.

8. Sample Size for the Training Set:

The document does not describe any training set or machine learning components for the Innovision Audio device. The device is a physical system, and its evaluation relies on direct performance testing against established standards, not on a machine learning model that would require a training set.

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

As there is no mention of a training set or machine learning model, the establishment of ground truth for a training set is not applicable to this device description.

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