Jana G. Delfino

Andrea Kim, Niloufar Saharkhiz, Elena Sizikova et al.

Development of artificial intelligence (AI) techniques in medical imaging requires access to large-scale and diverse datasets for training and evaluation. In dermatology, obtaining such datasets remains challenging due to significant variations in patient populations, illumination conditions, and acquisition system characteristics. In this work, we propose S-SYNTH, the first knowledge-based, adaptable open-source skin simulation framework to rapidly generate synthetic skin, 3D models and digitally rendered images, using an anatomically inspired multi-layer, multi-component skin and growing lesion model. The skin model allows for controlled variation in skin appearance, such as skin color, presence of hair, lesion shape, and blood fraction among other parameters. We use this framework to study the effect of possible variations on the development and evaluation of AI models for skin lesion segmentation, and show that results obtained using synthetic data follow similar comparative trends as real dermatologic images, while mitigating biases and limitations from existing datasets including small dataset size, lack of diversity, and underrepresentation.

Elena Sizikova, Niloufar Saharkhiz, Diksha Sharma et al.

To generate evidence regarding the safety and efficacy of artificial intelligence (AI) enabled medical devices, AI models need to be evaluated on a diverse population of patient cases, some of which may not be readily available. We propose an evaluation approach for testing medical imaging AI models that relies on in silico imaging pipelines in which stochastic digital models of human anatomy (in object space) with and without pathology are imaged using a digital replica imaging acquisition system to generate realistic synthetic image datasets. Here, we release M-SYNTH, a dataset of cohorts with four breast fibroglandular density distributions imaged at different exposure levels using Monte Carlo x-ray simulations with the publicly available Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) toolkit. We utilize the synthetic dataset to analyze AI model performance and find that model performance decreases with increasing breast density and increases with higher mass density, as expected. As exposure levels decrease, AI model performance drops with the highest performance achieved at exposure levels lower than the nominal recommended dose for the breast type.

Christopher Wiedeman, Anastasiia Sarmakeeva, Elena Sizikova et al.

One of the key impediments for developing and assessing robust medical imaging algorithms is limited access to large-scale datasets with suitable annotations. Synthetic data generated with plausible physical and biological constraints may address some of these data limitations. We propose the use of physics simulations to generate synthetic images with pixel-level segmentation annotations, which are notoriously difficult to obtain. Specifically, we apply this approach to breast imaging analysis and release T-SYNTH, a large-scale open-source dataset of paired 2D digital mammography (DM) and 3D digital breast tomosynthesis (DBT) images. Our initial experimental results indicate that T-SYNTH images show promise for augmenting limited real patient datasets for detection tasks in DM and DBT. Our data and code are publicly available at https://github.com/DIDSR/tsynth-release.

Jana G. Delfino, Jason L. Granstedt, Frank W. Samuelson et al.

Artificial intelligence (AI) is being deployed within radiology at a rapid pace. AI has proven an excellent tool for reconstructing and enhancing images that appear sharper, smoother, and more detailed, can be acquired more quickly, and allowing clinicians to review them more rapidly. However, incorporation of AI also introduces new failure modes and can exacerbate the disconnect between perceived quality of an image and information content of that image. Understanding the limitations of AI-enabled image reconstruction and enhancement is critical for safe and effective use of the technology. Hence, the purpose of this communication is to bring awareness to limitations when AI is used to reconstruct or enhance a radiological image, with the goal of enabling users to reap benefits of the technology while minimizing risks.

Elena Sizikova, Andreu Badal, Jana G. Delfino et al.

A key challenge for the development and deployment of artificial intelligence (AI) solutions in radiology is solving the associated data limitations. Obtaining sufficient and representative patient datasets with appropriate annotations may be burdensome due to high acquisition cost, safety limitations, patient privacy restrictions or low disease prevalence rates. In silico data offers a number of potential advantages to patient data, such as diminished patient harm, reduced cost, simplified data acquisition, scalability, improved quality assurance testing, and a mitigation approach to data imbalances. We summarize key research trends and practical uses for synthetically generated data for radiological applications of AI. Specifically, we discuss different types of techniques for generating synthetic examples, their main application areas, and related quality control assessment issues. We also discuss current approaches for evaluating synthetic imaging data. Overall, synthetic data holds great promise in addressing current data availability gaps, but additional work is needed before its full potential is realized.

Ghada Zamzmi, Kesavan Venkatesh, Brandon Nelson et al.

Background: Machine learning (ML) methods often fail with data that deviates from their training distribution. This is a significant concern for ML-enabled devices in clinical settings, where data drift may cause unexpected performance that jeopardizes patient safety. Method: We propose a ML-enabled Statistical Process Control (SPC) framework for out-of-distribution (OOD) detection and drift monitoring. SPC is advantageous as it visually and statistically highlights deviations from the expected distribution. To demonstrate the utility of the proposed framework for monitoring data drift in radiological images, we investigated different design choices, including methods for extracting feature representations, drift quantification, and SPC parameter selection. Results: We demonstrate the effectiveness of our framework for two tasks: 1) differentiating axial vs. non-axial computed tomography (CT) images and 2) separating chest x-ray (CXR) from other modalities. For both tasks, we achieved high accuracy in detecting OOD inputs, with 0.913 in CT and 0.995 in CXR, and sensitivity of 0.980 in CT and 0.984 in CXR. Our framework was also adept at monitoring data streams and identifying the time a drift occurred. In a simulation with 100 daily CXR cases, we detected a drift in OOD input percentage from 0-1% to 3-5% within two days, maintaining a low false-positive rate. Through additional experimental results, we demonstrate the framework's data-agnostic nature and independence from the underlying model's structure. Conclusion: We propose a framework for OOD detection and drift monitoring that is agnostic to data, modality, and model. The framework is customizable and can be adapted for specific applications.

Miguel A. Lago, Ghada Zamzmi, Brandon Eich et al.

Explainability features are intended to provide insight into the internal mechanisms of an AI device, but there is a lack of evaluation techniques for assessing the quality of provided explanations. We propose a framework to assess and report explainable AI features. Our evaluation framework for AI explainability is based on four criteria: 1) Consistency quantifies the variability of explanations to similar inputs, 2) Plausibility estimates how close the explanation is to the ground truth, 3) Fidelity assesses the alignment between the explanation and the model internal mechanisms, and 4) Usefulness evaluates the impact on task performance of the explanation. Finally, we developed a scorecard for AI explainability methods that serves as a complete description and evaluation to accompany this type of algorithm. We describe these four criteria and give examples on how they can be evaluated. As a case study, we use Ablation CAM and Eigen CAM to illustrate the evaluation of explanation heatmaps on the detection of breast lesions on synthetic mammographies. The first three criteria are evaluated for clinically-relevant scenarios. Our proposed framework establishes criteria through which the quality of explanations provided by AI models can be evaluated. We intend for our framework to spark a dialogue regarding the value provided by explainability features and help improve the development and evaluation of AI-based medical devices.

Ghada Zamzmi, Adarsh Subbaswamy, Elena Sizikova et al.

Although interest in synthetic medical data (SMD) for training and testing AI methods is growing, the absence of a standardized framework to evaluate its quality and applicability hinders its wider adoption. Here, we outline an evaluation framework designed to meet the unique requirements of medical applications, and introduce SMD Card, which can serve as comprehensive reports that accompany artificially generated datasets. This card provides a transparent and standardized framework for evaluating and reporting the quality of synthetic data, which can benefit SMD developers, users, and regulators, particularly for AI models using SMD in regulatory submissions.