(81 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 evoke physiological processes detectable by the MRI scanner and to collect behavioral responses from the patient. These data, when interpreted by a trained physician, may assist in the diagnosis of brain pathology and may be used in the planning and monitoring of medical treatments.
This is the same intended use as previously cleared for the fMRI Hardware System, K073099.
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 system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the nordicAktiva stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, VisualSystem, ResponseGrip, SyncBox and nordicAktiva.
The intended use of the system is to support 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 to patients suffering from a brain tumor in both the pre-operative and post-operative stage by examining the area of the brain affected.
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. As the timing of the data is critical to make sure that the correct MR image of the brain activity is linked to the stimulus presented, a synchronization unit [SyncBox] connected between the MR-scanner and the PC running nordicAktiva, a stimulus presentation software, is included in the System to make sure that the synchronization is correct.
The stimulus presentation PC hardware is not a part of the system.
Figure 1 presents the complete configuration of the fRMI Hardware System. All signals entering or leaving the scanner room are received and transmitted by use of fiber optics. The system allows video and audio signals from the stimulus PC to enter the shielded scanner room and to be presented to the subject lying inside the MR. The subject responds to the stimulus by using the handheld grips.
The provided 510(k) summary (K080515) describes modifications to an fMRI Hardware System, specifically the addition of software named nordicAktiva. However, the document does not contain any information regarding specific acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or a detailed study proving the device meets these criteria in the context of an AI/algorithm-driven medical device submission.
The submission focuses on establishing substantial equivalence for a hardware system with an added software module that provides "the same basic functionality for stimulus presentation and data recording of the software currently used with the system."
Therefore, based solely on the provided text:
1. Table of acceptance criteria and the reported device performance:
Not applicable. The document does not specify quantitative acceptance criteria (e.g., performance metrics like sensitivity, specificity, or accuracy) for the device's diagnostic capabilities or define how the added software module's "performance" was measured against such criteria. The "Summary of Testing" merely states the system "has been tested for function and safety and fulfills all requirement specifications," which is a general statement rather than specific performance numbers against defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
Not applicable. No sample size for a test set (e.g., patient cases, images) is mentioned because no clinical performance study demonstrating diagnostic efficacy against specific metrics for the added software is detailed. The testing described is functional and safety-related for the hardware system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment is described, as no clinical performance study requiring such a process is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The document does not describe an AI/algorithm for diagnostic interpretation. It is a stimulus presentation and response collection system. Therefore, no MRMC study or AI assistance effect size is discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a hardware system with software for stimulus presentation and data collection. It is not an AI algorithm intended for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth for diagnostic purposes is mentioned. The system's function is to present stimuli and collect responses for fMRI studies, which a trained physician then interprets.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as the device does not employ machine learning or AI algorithms requiring such a set for its operation.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML algorithm, there is no description of how ground truth for such a set was established.
Summary based on the document:
The 510(k) submission for the fMRI Hardware System (K080515) is a "Special: Device Modification" focused on integrating a software module (nordicAktiva) into an existing, previously cleared hardware system (K073099). The core claim is that the added software provides "the same basic functionality for stimulus presentation and data recording" as third-party software previously used with the system. The submission relies on establishing substantial equivalence to the predicate device, with functional and safety testing for the hardware system being the primary evidence presented. It does not detail a clinical performance study with quantitative acceptance criteria typically associated with AI/algorithm-driven diagnostic devices.
§ 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.