(18 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 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 audio and video stimuli to the patient and the patient gives feedback through a pair of handheld grips. A synchronization module synchronizes the Stimuli PC (not a part of the system) to the MR scanner. The System consists of four subsystems: AudioSystem, VisualSystem, ResponseGrip and a SyncBox.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NordicNeuroLab fMRI Hardware System:
Acceptance Criteria and Device Performance Study (K073099)
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided 510(k) summary does not explicitly list specific acceptance criteria with numerical targets or thresholds for device performance. It states generally that "The NordicNeuroLab fMRI system has been tested for function and safety and fulfills all requirement specifications." Without access to the full requirement specifications mentioned, precise quantitative acceptance criteria cannot be extracted.
Therefore, the table below reflects the general statement of compliance rather than specific, measurable criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functionality | "Fulfills all requirement specifications" to facilitate auditory and visual stimulation and response collection for fMRI. |
| Safety | "Fulfills all requirement specifications" for safe operation within an MR environment. |
| Substantial Equivalence | Found substantially equivalent to the predicate device, MindState Functional Data Acquisition Device (fDAD), K043290, based on having the same intended use and similar components. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set, nor does it describe data provenance (country of origin, retrospective/prospective). The summary indicates "Summary of Testing: The NordicNeuroLab fMRI system has been tested for function and safety and fulfills all requirement specifications." This phrasing suggests internal validation testing rather than a clinical study with a distinct "test set" in the context of AI evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The device is hardware for fMRI stimulus presentation and response collection, not an AI-driven diagnostic tool that would typically require expert-established ground truth for a test set in the same manner as an image analysis algorithm.
4. Adjudication Method for the Test Set
This information is not applicable/provided. There is no mention of a test set requiring adjudication in the context of this hardware device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided. The NordicNeuroLab fMRI Hardware System is a stimulus presentation and response collection system. It is not an AI algorithm designed to interpret medical images or assist human readers in diagnosis, so an MRMC comparative effectiveness study is not relevant to its stated purpose or evaluation.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable/provided. The device is a hardware system, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. Type of Ground Truth Used
This information is not applicable/provided. As a hardware system, the concept of "ground truth" as it applies to diagnostic algorithms (e.g., pathology, expert consensus) does not directly apply to the evaluation of its functionality. Its performance would be evaluated against engineering specifications for signal integrity, timing accuracy, and safety.
8. Sample Size for the Training Set
This information is not applicable/provided. The device is a hardware system and does not involve machine learning or a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As explained above, the concept of "training set" and "ground truth establishment" is not relevant for this hardware device.
Summary of Study Information Availability:
The provided 510(k) summary is for a hardware system (fMRI stimulus presentation and response collection), not an AI-driven diagnostic or image analysis software. Therefore, many of the typical evaluation parameters requested for AI/algorithm-based devices (like test/training sets, ground truth, expert adjudication, MRMC studies) are not relevant or applicable to this submission and are consequently not found in the document. The submission focuses on substantial equivalence to a predicate device and basic functional and safety testing for a hardware product.
§ 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.