Aldo Badano

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.

Rucha Deshpande, Tahsin Rahman, Miguel Lago et al.

Synthetic data provides a promising approach to address data scarcity for training machine learning models; however, adoption without proper quality assessments may introduce artifacts, distortions, and unrealistic features that compromise model performance and clinical utility. This work introduces a novel knowledge-based anomaly detection method for detecting network-induced shape artifacts in synthetic images. The introduced method utilizes a two-stage framework comprising (i) a novel feature extractor that constructs a specialized feature space by analyzing the per-image distribution of angle gradients along anatomical boundaries, and (ii) an isolation forest-based anomaly detector. We demonstrate the effectiveness of the method for identifying network-induced shape artifacts in two synthetic mammography datasets from models trained on CSAW-M and VinDr-Mammo patient datasets respectively. Quantitative evaluation shows that the method successfully concentrates artifacts in the most anomalous partition (1st percentile), with AUC values of 0.97 (CSAW-syn) and 0.91 (VMLO-syn). In addition, a reader study involving three imaging scientists confirmed that images identified by the method as containing network-induced shape artifacts were also flagged by human readers with mean agreement rates of 66% (CSAW-syn) and 68% (VMLO-syn) for the most anomalous partition, approximately 1.5-2 times higher than the least anomalous partition. Kendall-Tau correlations between algorithmic and human rankings were 0.45 and 0.43 for the two datasets, indicating reasonable agreement despite the challenging nature of subtle artifact detection. This method is a step forward in the responsible use of synthetic data, as it allows developers to evaluate synthetic images for known anatomic constraints and pinpoint and address specific issues to improve the overall quality of a synthetic dataset.

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.

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.

Prabhat Kc, Rongping Zeng, Nirmal Soni et al.

Deep learning (DL) methods are currently being explored to restore images from sparse-view-, limited-data-, and undersampled-based acquisitions in medical applications. Although outputs from DL may appear visually appealing based on likability/subjective criteria (such as less noise, smooth features), they may also suffer from hallucinations. This issue is further exacerbated by a lack of easy-to-use techniques and robust metrics for the identification of hallucinations in DL outputs. In this work, we propose performing Fourier Ring Correlation (FRC) analysis over small patches and concomitantly (s)canning across DL outputs and their reference counterparts to detect hallucinations (termed as sFRC). We describe the rationale behind sFRC and provide its mathematical formulation. The parameters essential to sFRC may be set using predefined hallucinated features annotated by subject matter experts or using imaging theory-based hallucination maps. We use sFRC to detect hallucinations for three undersampled medical imaging problems: CT super-resolution, CT sparse view, and MRI subsampled restoration. In the testing phase, we demonstrate sFRC's effectiveness in detecting hallucinated features for the CT problem and sFRC's agreement with imaging theory-based outputs on hallucinated feature maps for the MR problem. Finally, we quantify the hallucination rates of DL methods on in-distribution versus out-of-distribution data and under increasing subsampling rates to characterize the robustness of DL methods. Beyond DL-based methods, sFRC's effectiveness in detecting hallucinations for a conventional regularization-based restoration method and a state-of-the-art unrolled method is also shown.

Victor Garcia, Mariia Sidulova, Aldo Badano

Generative artificial intelligence (GenAI) represent an emerging paradigm within artificial intelligence, with applications throughout the medical enterprise. Assessing GenAI applications necessitates a comprehensive understanding of the clinical task and awareness of the variability in performance when implemented in actual clinical environments. Presently, a prevalent method for evaluating the performance of generative models relies on quantitative benchmarks. Such benchmarks have limitations and may suffer from train-to-the-test overfitting, optimizing performance for a specified test set at the cost of generalizability across other task and data distributions. Evaluation strategies leveraging human expertise and utilizing cost-effective computational models as evaluators are gaining interest. We discuss current state-of-the-art methodologies for assessing the performance of GenAI applications in healthcare and medical devices.

Jason Granstedt, Prabhat Kc, Rucha Deshpande et al.

Computer methods in medical devices are frequently imperfect and are known to produce errors in clinical or diagnostic tasks. However, when deep learning and data-based approaches yield output that exhibit errors, the devices are frequently said to hallucinate. Drawing from theoretical developments and empirical studies in multiple medical device areas, we introduce a practical and universal definition that denotes hallucinations as a type of error that is plausible and can be either impactful or benign to the task at hand. The definition aims at facilitating the evaluation of medical devices that suffer from hallucinations across product areas. Using examples from imaging and non-imaging applications, we explore how the proposed definition relates to evaluation methodologies and discuss existing approaches for minimizing the prevalence of hallucinations.

Seyed Kahaki, Alexander R. Webber, Ghada Zamzmi et al.

In modern cancer diagnostics, Whole Slide Imaging (WSI) is widely used to digitize tissue specimens for detailed, high-resolution examination; however, other diagnostic approaches, such as liquid biopsy and molecular testing, are also utilized based on the cancer type and clinical context. While WSI has revolutionized digital histopathology by enabling automated, precise analysis, it remains vulnerable to artifacts introduced during slide preparation and scanning. These artifacts can compromise downstream image analysis. To address this challenge, we propose and compare three robust artifact detection approaches for WSIs: (1) a foundation model-based approach (FMA) using a fine-tuned Unified Neural Image (UNI) architecture, (2) a deep learning approach (DLA) built on a ResNet50 backbone, and (3) a knowledge-based approach (KBA) leveraging handcrafted features from texture, color, and frequency-based metrics. The methods target six common artifact types: tissue folds, out-of-focus regions, air bubbles, tissue damage, marker traces, and blood contamination. Evaluations were conducted on 50,000+ image patches from diverse scanners (Hamamatsu, Philips, Leica Aperio AT2) across multiple sites. The FMA achieved the highest patch-wise AUROC of 0.995 (95% CI [0.994, 0.995]), outperforming the ResNet50-based method (AUROC: 0.977, 95% CI [0.977, 0.978]) and the KBA (AUROC: 0.940, 95% CI [0.933, 0.946]). To translate detection into actionable insights, we developed a quality report scorecard that quantifies high-quality patches and visualizes artifact distributions.

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.