(90 days)
The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.
The system consists of a pair of glasses coupled with an audio transducer and noise canceling headset. The headset decreases gradient noise by up to 30 dB and includes a microphone that permits two way communication between the technologist and the patient. The video option provides an illusion of viewing a 60" screen and can be viewed in 3D. Television can be viewed with 180,000 pixels.
Here's a breakdown of the acceptance criteria and study information based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| MRI Compatibility (Safe for use in an MRI environment) | "UCLS Dept of Neurology concludes M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is MRI Compatible and MRI Safe." |
| MRI Safety (Does not pose a hazard or interfere with MRI operation) | "UCLS Dept of Neurology concludes M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is MRI Compatible and MRI Safe." |
| Effective noise reduction (to improve patient comfort) | "The headset decreases gradient noise by up to 30 dB" |
| Ability to provide audio and visual to patients (as intended) | "provides an illusion of viewing a 60" screen and can be viewed in 3D. Television can be viewed with 180,000 pixels." |
| Substantial equivalence to predicate device (Avocet Silent Scan, K921891) | Concluded to be substantially equivalent. |
Study Information
The provided document describes a single performance study, primarily focused on MRI compatibility and safety.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Study conducted by UCLS Dept of Neurology."
- Data Provenance: The study was conducted by the UCLA Department of Neurology. It's a prospective study in the sense that the device was evaluated, but the details of the study design (e.g., number of participants, specific tests performed) are not provided. The country of origin is the USA (UCLA).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document only states "Study conducted by UCLS Dept of Neurology concludes..." implying experts from that department made the determination.
- Qualifications of Experts: Not specified beyond being associated with the "UCLS Dept of Neurology."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an accessory to MRI for patient comfort and communication, not an AI-powered diagnostic tool, so such a study would not be applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a hardware device providing audio/visual functionality and noise reduction, not an algorithm. Its performance is inherent in its physical and electrical characteristics and its interaction with the MRI environment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for MRI compatibility and safety was established by the "UCLS Dept of Neurology." This would typically involve expert assessment against established safety standards for medical devices in an MRI environment, likely through specific testing protocols (e.g., assessing magnetic deflection, heating, image artifact generation, acoustic noise levels). The "30 dB" noise reduction is a direct measurement.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable, as there is no training set for this type of device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.