SaMD Clinical Evaluation Toolkit
SaMD clinical evaluation plan, algorithm performance protocol, real-world evidence study, intended use determination, PCCP template, and post-market monitoring plan — for AI/ML and software medical devices.
What You Get
SaMD Clinical Evaluation Plan (IMDRF Framework)
Clinical evaluation plan template structured per the IMDRF SaMD Clinical Evidence guidance and FDA's 2022 Digital Health Center of Excellence approach. Covers SaMD categorization (significance of information x state of healthcare situation), clinical evidence category determination (valid clinical association, analytical validation, clinical validation), and the clinical evaluation methodology proportionate to SaMD risk category.
SaMD Algorithm Performance Evaluation Protocol
Technical evaluation protocol for AI/ML-based SaMD algorithm performance. Covers training/validation/test dataset documentation, performance metric selection (sensitivity, specificity, PPV, NPV, AUC), subgroup analysis requirements, reference standard definition, and the locked algorithm vs. adaptive algorithm distinction that determines whether ongoing performance monitoring is required.
Real-World Evidence (RWE) Study Protocol for SaMD
Study protocol template for generating real-world evidence to support SaMD clinical validation. Covers study design selection (prospective vs. retrospective, single-arm vs. comparative), data source qualification, outcome measure definition, statistical analysis plan, and the RWE data quality standards FDA expects for SaMD submissions.
SaMD Intended Use and Clinical Significance Determination Worksheet
Structured worksheet for determining SaMD intended use, clinical significance classification per IMDRF N41, and the regulatory pathway implications. Covers the four IMDRF significance categories, the state of healthcare situation matrix, and the mapping to FDA Digital Health Software Precertification and SaMD-specific guidance documents.
Predetermined Change Control Plan (PCCP) Template
PCCP template per FDA's 2023 Predetermined Change Control Plan guidance for AI/ML-based SaMD. Covers the description of anticipated modifications, performance monitoring plan, methodology for the proposed changes, and the impact assessment framework that enables algorithm updates without a new 510k submission for pre-specified changes.
SaMD Post-Market Performance Monitoring Plan
Post-market monitoring plan for SaMD clinical performance. Covers algorithm drift detection, real-world performance metric tracking, comparison to pre-market validation performance, performance degradation response procedure, and the ongoing clinical evaluation update cycle required under FDA and EU MDR MDR post-market surveillance obligations for SaMD.
FAQ
What is the IMDRF SaMD clinical evidence framework?
IMDRF N41 defines a tiered clinical evidence framework based on two axes: the significance of the information provided by SaMD (inform, drive, treat/diagnose) and the state of the healthcare situation (critical, serious, non-serious). Higher significance combined with critical situations requires stronger clinical evidence.
What is a PCCP and when is it required?
A Predetermined Change Control Plan is a document submitted with a 510k or De Novo that describes anticipated future modifications and how they will be validated. FDA allows these pre-specified changes to be implemented without a new submission, enabling continuous improvement of AI/ML-based SaMD.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal