(103 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.
nordicAktiva is a stimulus presentation software intended to be used by trained professionals to facilitate auditory and visual stimulation to be used in functional MR maging (fMRI)based on BOLD contrast. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
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.
nordicAktiva is a stimulus presentation software 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. In addition, it records responses from the NordicNeuroLab ResponseGrips.
The device is indicated for use during BOLD fMRI examinations of individuals over 2 years of age. It is not intended for the diagnosis of disease or for the direct treatment of conditions.
nordicAktiva would be used in an MRI department of a hospital or clinic, when a functional MRI exam based on BOLD contrast is required involving the provision of visual or auditory stimulation to a subject inside the MRI scanner.
The system presents auditory and visual stimulus to the patient gives feedback through a pair of handheld grips. A synchronizes the stimulus presentation software with the MR scanner. The System consists of five subsystems: AudioSystem, ResponseGrip, SyncBox and nordicAktiva.
The system is used for fMRI studies. fMRI stands for functional Magnetic Resonance Imaging. This technique is primarily used for determining which area of the brain is responsible for specific processes controlling essential functions such as movement, speech, hearing, and vision. This information can form part of the pre-operative planning process in patients with brain tumors, for example. Functional MRI can also be used for research into specific neurological conditions or investigating cognitive function and networks in general.
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 auditory stimulation is critical to make sure that the correct MR image of the activated brain 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 does NOT describe acceptance criteria for a device that involves performance metrics such as accuracy, sensitivity, or specificity. Instead, the document is a 510(k) premarket notification for an fMRI Hardware System where the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device.
The "acceptance criteria" discussed in the document relate to compliance with regulatory standards and software verification, not clinical performance metrics of the device in diagnosing or aiding in diagnosis. The device, nordicAktiva, is a stimulus presentation and response collection system for fMRI, and it is explicitly stated that "It is not intended for the diagnosis of disease or for the direct treatment of conditions."
Therefore, the requested information regarding a table of acceptance criteria and reported device performance (in the sense of diagnostic accuracy), sample size for test sets, expert involvement in ground truth, MRMC studies, and standalone performance is not applicable to this submission, as the device's function does not involve such diagnostic performance evaluations.
The document states that a new version of the software, nordicAktiva, was updated, and the testing performed was focused on verifying that the modified device fulfills its defined characteristics and requirements, maintaining substantial equivalence to its predicate.
Here's a breakdown of what the document does provide regarding "acceptance criteria" and "study":
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, AUC) and corresponding reported device performance values. The closest information is a comparison of technological characteristics between the modified device and the predicate in Section 1.4.1. The "acceptance criteria" for this submission are more aligned with regulatory compliance and functional verification.
From Section 1.5.1 and 1.5.2, the acceptance criteria are implicit in meeting:
- International and FDA-recognized consensus standards (ISO 14971, IEC 62304, IEC 62366-1).
- Design and performance specifications, as well as user needs, when operated according to instructions.
- Intended use, technological characteristics claims, requirement specifications, and risk management results.
The "reported device performance" is the conclusion that the device "demonstrates compliance" with these standards and "meets the acceptance criteria and is adequate for its intended use and specifications."
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical performance study with patient data. The testing mentioned (Section 1.5.1) is "non-clinical performance testing" and "verification and validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results." This implies engineering and software testing rather than a clinical study with a patient sample size. Therefore, sample size and data provenance in that context are not relevant or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The type of testing performed (non-clinical performance, verification, and validation) would typically involve qualified engineers and testers, but not "experts" to establish "ground truth" for diagnostic performance, as the device is not intended for diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is typically used in clinical studies for establishing ground truth, which is not the nature of the testing described.
5. 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
No. An MRMC study is not mentioned. The device is a stimulus presentation and response collection system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device's function is to facilitate fMRI by presenting stimuli and collecting responses, not to operate as a standalone diagnostic algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. "Ground truth" in the diagnostic sense is not relevant for the type of device and testing described. The "truth" for this device would be its correct functioning according to its design specifications (e.g., stimulus presented correctly, response recorded accurately, synchronization maintained).
8. The sample size for the training set
Not applicable. There is no mention of a training set for a machine learning or AI model, as this is not an AI-based diagnostic device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this information is not provided.
§ 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.