KEYWORDS: Medical imaging, Data modeling, Medical devices, Education and training, Imaging devices, Performance modeling, Instrument modeling, Machine learning, Design and modelling, Medical device development
PurposeTo introduce developers to medical device regulatory processes and data considerations in artificial intelligence and machine learning (AI/ML) device submissions and to discuss ongoing AI/ML-related regulatory challenges and activities.ApproachAI/ML technologies are being used in an increasing number of medical imaging devices, and the fast evolution of these technologies presents novel regulatory challenges. We provide AI/ML developers with an introduction to U.S. Food and Drug Administration (FDA) regulatory concepts, processes, and fundamental assessments for a wide range of medical imaging AI/ML device types.ResultsThe device type for an AI/ML device and appropriate premarket regulatory pathway is based on the level of risk associated with the device and informed by both its technological characteristics and intended use. AI/ML device submissions contain a wide array of information and testing to facilitate the review process with the model description, data, nonclinical testing, and multi-reader multi-case testing being critical aspects of the AI/ML device review process for many AI/ML device submissions. The agency is also involved in AI/ML-related activities that support guidance document development, good machine learning practice development, AI/ML transparency, AI/ML regulatory research, and real-world performance assessment.ConclusionFDA’s AI/ML regulatory and scientific efforts support the joint goals of ensuring patients have access to safe and effective AI/ML devices over the entire device lifecycle and stimulating medical AI/ML innovation.
Artificial intelligence (AI)-based reconstruction is a promising method for MRI reconstruction. However, deep neural networks may exhibit instabilities in conditions that are difficult to identify with patient images. The purpose of this work is to investigate whether digital phantoms can help evaluate the performance of AI-based MRI image reconstruction. We chose AUTOMAP as an example of AI-based reconstruction method, with the network being trained with 50,000 paired patches of T1W healthy brain images and corresponding noisy k-space data. We tested the network with noisy k-space brain images, digital phantom images, and hybrid images (i.e., brain test images that contained an inserted lesion-like object). The set of brain test images was used to evaluate the global reconstruction accuracy in terms of mean squared error (MSE). The digital phantoms were designed to test image homogeneity and resolution. The hybrid images were constructed to mimic unhealthy patient for testing whether the AI reconstruction model trained with all healthy brain images would yield equal performance on abnormal brain test images. We also selected two test cases (one brain and one phantom) to quantitatively compare AI-based reconstruction and IFFT in terms of local reconstruction accuracy, which was measured by mean intensity and homogeneity of a region of interest (ROI) in a range of noise levels.
It was observed that AUTOMAP reduced noise variance on brain images within our pre-trained noise range compared to the IFFT reconstruction, but increased variance on phantoms creating inhomogeneous appearance in reconstructed phantom images. In hybrid images, similar degradation of performance was shown in the lesion-like area. Our preliminary results demonstrated that performance of the neural network was highly dependent on the training dataset. If the training data only includes healthy subjects, reconstruction of pathology regions may not be as good as healthy anatomic regions. Digital phantoms helped identify this potential generalizability issue in this AI-based MRI reconstruction.
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