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Aaron Ceross

Publications and source records attributed to Aaron Ceross.

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Evaluating Model Retraining under Drift: Paired Comparisons of Cumulative Subgroup Disparity

Choosing when to retrain a deployed classifier requires assessing subgroup error rates across the sequence of models used, including periods between updates. We compare complete scheduled, loss-triggered, and subgroup-gap-triggered policies with retaining the initial model on the same observations and delayed labels. For true-positive and false-positive rates separately, the outcome is the paired difference in absolute subgroup gaps summed over deployment windows. Population evaluation in simulation, action records, and alternative schedules assess how measurement and retraining behaviour affect these comparisons. In a follow-up sample of 400 new trajectories per condition across two simulated drift regimes, all three policies had lower mean cumulative disparity, equivalent to reductions of 0.04 to 0.88 percentage points in the average gap per window. Evaluating the unchanged models against the known generating distributions preserved all mean directions, but finite-window and population comparisons agreed on whether updating increased, reduced or left cumulative disparity unchanged in 69 to 92 percent of trajectories. Under subgroup-specific drift, smaller true-positive-rate gaps accompanied lower sensitivity in both groups. In an exploratory American Community Survey replay, person weighting reversed all three race false-positive-rate mean comparisons without changing predictions or actions; all three weighted intervals included zero. Policy comparisons require group-specific rates, action distributions, and an explicit evaluation population alongside mean disparity. These analyses are non-confirmatory. Shared replay requires policy-independent observations and complete labels after the specified delay.

cs.LG

Measuring Cross-Jurisdictional Transfer of Medical Device Risk Concepts with Explainable AI

Medical device regulators in the United States(FDA), China (NMPA), and Europe (EU MDR) all use the language of risk, but classify devices through structurally different mechanisms. Whether these apparently shared concepts carry transferable classificatory signal across jurisdictions remains unclear. We test this by reframing explainable AI as an empirical probe of cross-jurisdictional regulatory overlap. Using 141,942 device records, we derive seven EU MDR risk factors, including implantability, invasiveness, and duration of use, and evaluate their contribution across a three-by-three transfer matrix. Under a symmetric extraction pipeline designed to remove jurisdiction-specific advantages, factor contribution is negligible in all jurisdictions, indicating that clean cross-jurisdictional signal is at most marginal. Under jurisdiction specific pipelines, a modest gain appears only in the EU MDR-to-NMPA direction, but sensitivity analyses show that this effect is weak, context-dependent, and partly confounded by extraction and representation choices. Reverse direction probes show strong asymmetry: FDA-derived factors do not transfer meaningfully in any direction, and NMPA-derived factors do not carry signal back to EU MDR. Zero-shot transfer further fails on EU MDR Class I, consistent with a mismatch between residual and positional class definitions. Overall, cross-jurisdictional transfer is sparse, asymmetric, and weak. Shared regulatory vocabulary does not, under this operationalisation, translate into strong portable classification logic. The findings challenge a common assumption in cross-jurisdictional regulatory AI and show how explainable AI can be used to measure, rather than assume, regulatory overlap.

eess.SY

Standard Applicability Judgment and Cross-jurisdictional Reasoning: A RAG-based Framework for Medical Device Compliance

Identifying the appropriate regulatory standard applicability remains a critical yet understudied challenge in medical device compliance, frequently necessitating expert interpretation of fragmented and heterogeneous documentation across different jurisdictions. To address this challenge, we introduce a modular AI system that leverages a retrieval-augmented generation (RAG) pipeline to automate standard applicability determination. Given a free-text device description, our system retrieves candidate standards from a curated corpus and uses large language models to infer jurisdiction-specific applicability, classified as Mandatory, Recommended, or Not Applicable, with traceable justifications. We construct an international benchmark dataset of medical device descriptions with expert-annotated standard mappings, and evaluate our system against retrieval-only, zero-shot, and rule-based baselines. The proposed approach attains a classification accuracy of 73% and a Top-5 retrieval recall of 87%, demonstrating its effectiveness in identifying relevant regulatory standards. We introduce the first end-to-end system for standard applicability reasoning, enabling scalable and interpretable AI-supported regulatory science. Notably, our region-aware RAG agent performs cross-jurisdictional reasoning between Chinese and U.S. standards, supporting conflict resolution and applicability justification across regulatory frameworks.

cs.AI

AI for Regulatory Affairs: Balancing Accuracy, Interpretability, and Computational Cost in Medical Device Classification

Regulatory affairs, which sits at the intersection of medicine and law, can benefit significantly from AI-enabled automation. Classification task is the initial step in which manufacturers position their products to regulatory authorities, and it plays a critical role in determining market access, regulatory scrutiny, and ultimately, patient safety. In this study, we investigate a broad range of AI models -- including traditional machine learning (ML) algorithms, deep learning architectures, and large language models -- using a regulatory dataset of medical device descriptions. We evaluate each model along three key dimensions: accuracy, interpretability, and computational cost.

cs.AI

Toward Automated Regulatory Decision-Making: Trustworthy Medical Device Risk Classification with Multimodal Transformers and Self-Training

Accurate classification of medical device risk levels is essential for regulatory oversight and clinical safety. We present a Transformer-based multimodal framework that integrates textual descriptions and visual information to predict device regulatory classification. The model incorporates a cross-attention mechanism to capture intermodal dependencies and employs a self-training strategy for improved generalization under limited supervision. Experiments on a real-world regulatory dataset demonstrate that our approach achieves up to 90.4% accuracy and 97.9% AUROC, significantly outperforming text-only (77.2%) and image-only (54.8%) baselines. Compared to standard multimodal fusion, the self-training mechanism improved SVM performance by 3.3 percentage points in accuracy (from 87.1% to 90.4%) and 1.4 points in macro-F1, suggesting that pseudo-labeling can effectively enhance generalization under limited supervision. Ablation studies further confirm the complementary benefits of both cross-modal attention and self-training.

cs.LG

The Use of Readability Metrics in Legal Text: A Systematic Literature Review

Understanding the text in legal documents can be challenging due to their complex structure and the inclusion of domain-specific jargon. Laws and regulations are often crafted in such a manner that engagement with them requires formal training, potentially leading to vastly different interpretations of the same texts. Linguistic complexity is an important contributor to the difficulties experienced by readers. Simplifying texts could enhance comprehension across a broader audience, not just among trained professionals. Various metrics have been developed to measure document readability. Therefore, we adopted a systematic review approach to examine the linguistic and readability metrics currently employed for legal and regulatory texts. A total of 3566 initial papers were screened, with 34 relevant studies found and further assessed. Our primary objective was to identify which current metrics were applied for evaluating readability within the legal field. Sixteen different metrics were identified, with the Flesch-Kincaid Grade Level being the most frequently used method. The majority of studies (73.5%) were found in the domain of "informed consent forms". From the analysis, it is clear that not all legal domains are well represented in terms of readability metrics and that there is a further need to develop more consensus on which metrics should be applied for legal documents.

cs.CL

Data-Driven Analysis of AI in Medical Device Software in China: Trends of Deep Learning and Traditional AI Based on Regulatory Data

Artificial intelligence (AI) in medical device software (MDSW) represents a transformative clinical technology, attracting increasing attention within both the medical community and the regulators. In this study, we leverage a data-driven approach to automatically extract and analyze AI-enabled medical devices (AIMD) from the National Medical Products Administration (NMPA) regulatory database. The continued increase in publicly available regulatory data requires scalable methods for analysis. Automation of regulatory information screening is essential to create reproducible insights that can be quickly updated in an ever changing medical device landscape. More than 4 million entries were assessed, identifying 2,174 MDSW registrations, including 531 standalone applications and 1,643 integrated within medical devices, of which 43 were AI-enabled. It was shown that the leading medical specialties utilizing AIMD include respiratory (20.5%), ophthalmology/endocrinology (12.8%), and orthopedics (10.3%). This approach greatly improves the speed of data extracting providing a greater ability to compare and contrast. This study provides the first extensive, data-driven exploration of AIMD in China, showcasing the potential of automated regulatory data analysis in understanding and advancing the landscape of AI in medical technology.

cs.AI

Uncovering Regulatory Affairs Complexity in Medical Products: A Qualitative Assessment Utilizing Open Coding and Natural Language Processing (NLP)

This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs. These interviews were analyzed using open coding and Natural Language Processing (NLP) techniques. The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (A) Regulatory language complexity, (B) Intricacies within the regulatory process, (C) Global-level complexities, (D) Database-related considerations, and (E) Product-level issues. The participants highlighted the need for strategies to streamline regulatory compliance, enhance interactions between regulatory bodies and industry players, and develop adaptable frameworks for rapid technological advancements. Emphasizing interdisciplinary collaboration and increased transparency, the study concludes that these elements are vital for establishing coherent and effective regulatory procedures in the medical device sector.

cs.CY

The efficacy potential of cyber security advice as presented in news articles

Cyber security advice is a broad church: it is thematically expansive, comprising expert texts, user-generated data consumed by individual users via informal learning, and much in-between. While there is evidence that cyber security news articles play a role in disseminating cyber security advice, the nature and extent of that role are not clear. We present a corpus of cyber security advice generated from mainstream news articles. The work was driven by two research objectives. The first objective was to ascertain what kind of actionable advice is being disseminated; the second was to explore ways of determining the efficacy potential of news-mediated security advice. The results show an increase in the generation of cyber security news articles, together with increases in vocabulary complexity and reading difficulty. We argue that these could present challenges for vulnerable users. We believe that this corpus and the accompanying analysis have the potential to inform future efforts to quantify and improve the efficacy potential of security advice dissemination.

cs.HC