(223 days)
The fMRI Hardware System is a stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast.
The VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays [VisualSystem HD] or by an in-room LCD monitor.
The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is useful when determining certain diseases, gaining more information about a patient's condition or investigating cognitive functions. The technique is also used for examining the area of the brain affected in patients suffering from a brain tumor in both the pre-operative and post-operative stages.
The System is used to present the stimulus necessary to provoke physiological processes in the brain. Visual [VisualSystem] and auditory [AudioSystem] stimulus and manual responses from the patient [ResponseGrips] are of primary interest. The timing of the visual and audio stimulation is critical to make sure that the correct MR image of the brains activity is linked to the stimulus presented. A synchronization unit [SyncBox], connected between the MR-scanner and the stimulus presentation software [nordicAktiva], is included in the system to make sure that the synchronization is correct.
The provided text is a 510(k) summary for a medical device (fMRI Hardware System, specifically an updated VisualSystem HD component) and does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic device.
This document describes a hardware system for presenting stimuli in fMRI studies, and the changes involve technical upgrades (e.g., higher resolution display, HDMI instead of VGA, integrated eye-tracking vs. separate unit). The testing discussed is primarily functional, biocompatibility, and electrical safety, consistent with a hardware device.
Therefore, I cannot extract the requested information from this document because it does not pertain to the performance of an AI/ML algorithm or diagnostic accuracy. The questions about AI model training, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not relevant to the described device and the information provided.
The document does contain information about:
- Device Name: fMRI Hardware System (specifically, the VisualSystem HD component).
- Intended Use: "A stimulus presentation and response collection system intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR Imaging (fMRI) based on BOLD contrast." (page 4)
- Testing Summary: Functional tests, biocompatibility tests (for a rubber eye guard), and electrical safety/EMC tests. (page 7)
- Sample Size for testing: Not explicitly stated as a "sample size" in the context of diagnostic accuracy, but functional, biocompatibility, and safety tests would have involved specific units or batches of the device.
To answer your specific questions, this document does not provide:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML. The "performance" mentioned is functional, biocompatibility, and safety.
- Sample sizes for a "test set" in an AI/ML context, nor data provenance.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance effect size.
- Results of a standalone (algorithm-only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
This is a regulatory submission for a hardware component upgrade, not an AI/ML diagnostic software.
§ 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.