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Your progress 0 of 9 lessons complete · up next: AI/ML-Enabled Medical Device [Start path](/terms/ai-ml-device?from=ai-ml-devices-deep-dive) 1. 1 [ Software & AI ## AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. Why this term here: The FDA definition that scopes what an 'AI-enabled device' actually is. ](/terms/ai-ml-device?from=ai-ml-devices-deep-dive)Mark done 2. 2 [ Software & AI ## Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. Why this term here: Pre-Determined Change Control Plan: pre-authorize model updates in the submission. ](/terms/ai-ml-pccp?from=ai-ml-devices-deep-dive)Mark done 3. 3 [ Software & AI ## Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. Why this term here: The FDA / MHRA / Health Canada joint principles for ML lifecycle. ](/terms/good-machine-learning-practice?from=ai-ml-devices-deep-dive)Mark done 4. 4 [ Software & AI ## Model Card Structured documentation of a machine learning model's intended use, performance, and limitations. Why this term here: The transparency artifact that pairs a model with its intended use and limits. ](/terms/model-card?from=ai-ml-devices-deep-dive)Mark done 5. 5 [ Software & AI ## Model Drift Monitoring Ongoing surveillance of input data and model outputs to detect performance degradation post-deployment. Why this term here: How to detect that a deployed model no longer performs as claimed. ](/terms/drift-monitoring?from=ai-ml-devices-deep-dive)Mark done 6. 6 [ Software & AI ## Explainability and Interpretability Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction. Why this term here: The XAI requirements that increasingly show up in premarket questions. ](/terms/explainability?from=ai-ml-devices-deep-dive)Mark done 7. 7 [ Software & AI ## Generative AI in Medical Devices Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow. Why this term here: The emerging category where PCCP alone is not yet sufficient. ](/terms/generative-ai-devices?from=ai-ml-devices-deep-dive)Mark done 8. 8 [ Software & AI ## Foundation Model (Healthcare) Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting. Why this term here: How large pretrained models change the risk conversation. ](/terms/foundation-model-health?from=ai-ml-devices-deep-dive)Mark done 9. 9 [ Software & AI ## Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. Why this term here: Almost every AI/ML device is SaMD; know why that framing matters. ](/terms/samd?from=ai-ml-devices-deep-dive)Mark done Finished the path? Test yourself with a quiz tailored to these 9 terms. [Take the AI/ML Devices Deep Dive quiz](/quiz?path=ai-ml-devices-deep-dive) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. 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