Regulatory
Regulatory Pathway
Synthia is currently an investigational software tool. We are developing a 510(k) submission pathway and building documentation to meet SaMD regulatory standards.
CURRENT STATUS
Synthia is an investigational software tool for research use only. Synthia has not received FDA 510(k) clearance or approval. It should not be used as the sole basis for clinical diagnosis or treatment decisions. All output is intended as a decision-support aid subject to pathologist review.
510(k) Pathway Planning
Synthia is developing a 510(k) premarket notification submission for IHC quantification software as a medical device aid. Our intended use aligns with the FDA's Software as a Medical Device (SaMD) risk classification framework under IEC 62304 and the Digital Health Center of Excellence (DHCoE) guidance.
The predicate device pathway for AI-powered IHC quantification software is evolving. We are tracking FDA's current thinking on AI/ML-based SaMD under the 2021 Action Plan for Artificial Intelligence/Machine Learning and subsequent guidance documents.
Our architecture is designed from the outset to support the documentation requirements of a regulatory-grade submission: reproducible model versioning, training-validation set separation, bias assessment by tumor type, and algorithmic change control procedures.
FDA Digital Health Center of Excellence Alignment
Our development approach follows the FDA Digital Health Center of Excellence (DHCoE) guidelines, including:
- Software documentation per IEC 62304 software development lifecycle standard
- AI/ML model documentation including training data provenance, annotation methodology, and performance characterization
- Algorithm change protocol (ACP) defining what model updates require re-validation vs. can be deployed under predetermined change controls
- Transparency reporting per FDA's proposed model cards approach for AI-based SaMD
Current Use — Research and Investigational Contexts
In its current form, Synthia is appropriate for:
- Research studies in academic and CLIA-certified laboratories
- Quality assurance and inter-laboratory concordance studies
- Pathologist training and education on IHC scoring consistency
- Internal validation and pilot studies to assess algorithmic performance in a specific laboratory environment
Synthia's output must not replace a licensed pathologist's clinical judgment. All results are provided as a decision-support aid and require review and sign-off by a qualified pathologist before any clinical application.
Questions?
If you have questions about Synthia's regulatory status, intended use limitations, or are evaluating the tool for a specific research or investigational context, please contact us directly at [email protected].
We are committed to full regulatory transparency. If you are a pathology department evaluating AI tools for institutional procurement, we will provide complete documentation of our validation methodology and current regulatory status.