(72 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 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the fMRI Hardware System:
The provided document, a 510(k) Summary for a device modification, offers limited details regarding specific quantitative acceptance criteria or a dedicated study report to "prove" the device meets them in the traditional sense of a clinical trial. Instead, the submission emphasizes substantial equivalence to an existing cleared device (K080515) and highlights function and safety testing to confirm the modified device (adding an in-room LCD monitor option) maintains performance.
Therefore, the information below is constructed based on the available text and highlights where specific details are not provided.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) for a device modification (adding an LCD monitor option) and the focus on substantial equivalence, the "acceptance criteria" are implied to be adherence to the original device's functionality and safety, as well as general expectations for such a system. The document does not provide numerical performance metrics or specific criterion thresholds in a table format.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Visual stimulus presentation (video) | "The same video signal can be presented on the coil-mounted display and the in-room LCD-monitor." (Section 3.4) |
| Functional Equivalence: Auditory stimulus presentation | Unchanged. The AudioSystem is not part of the modification. |
| Functional Equivalence: Response collection | Unchanged. The ResponseGrip is not part of the modification. |
| Functional Equivalence: Synchronization with MR scanner | Unchanged. The SyncBox and nordicAktiva are not part of the modification. |
| Safety: No new safety risks introduced by the modification | "The LCD monitor is placed outside magnets bore behind the MR scanner and is in no physical contact with the patient." (Section 3.4) "The fMRI Hardware System has been tested for function and safety and fulfills all requirement specifications." (Section 3.6) |
| Intended Use: Consistent with the original device | "The intended use for the modified fMRI Hardware System have remained unchanged." (Section 3.5) "This is the same intended use as previously cleared for the fMRI Hardware System, K080515." (Section 3.1) |
| Overall Performance: Meets all requirement specifications | "The fMRI Hardware System has been tested for function and safety and fulfills all requirement specifications." (Section 3.6) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of a clinical performance study. The testing mentioned in Section 3.6 ("The fMRI Hardware System has been tested for function and safety...") appears to be internal verification and validation testing of the hardware and software components, rather than a study involving patient data or expert interpretation.
Therefore, there is no explicit data provenance (e.g., country of origin, retrospective/prospective) related to a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. This type of submission, concerning a hardware accessory modification, typically focuses on engineering verification and validation rather than clinical performance studies that require expert-derived ground truth.
4. Adjudication Method for the Test Set
Since there is no mention of a test set requiring expert ground truth or interpretation, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was NOT done or reported. The submission is for a hardware system modification, not an AI-powered diagnostic tool where human reader performance would be a primary metric. Therefore, there is no effect size reported for human readers with vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No standalone performance study was conducted or reported in the context of a diagnostic algorithm. The device is a stimulus presentation and response collection system for fMRI studies, not an algorithm that provides diagnostic outputs.
7. Type of Ground Truth Used
Given that no clinical performance study or diagnostic algorithm evaluation is described, there is no mention of a specific type of ground truth (e.g., expert consensus, pathology, outcomes data) being used. The "ground truth" for the device's function would be its ability to accurately present stimuli and record responses, as determined by engineering tests and adherence to specifications.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This device is a hardware system, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, there is no ground truth establishment method for it described.
§ 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.