T-TF-028-006 AI Release Report
Table of contents
Purpose
Describe the purpose of this release report. Specify the device version and the role of this document in the release process.
Scope
Define the scope of this release, including the number and types of models covered.
Related Documents
| Document ID | Title | Relationship |
|---|---|---|
| R-TF-028-001 | AI/ML Description | |
| R-TF-028-002 | AI Development Plan | |
| R-TF-028-005 | AI Development Report | |
| R-TF-028-011 | AI Risk Assessment |
Package Details
Overview
Provide an overview of the algorithm package contents.
Model File Format
Describe the model file format (e.g., ONNX, TensorFlow SavedModel).
Configuration Files
Describe the configuration files included with each model.
Clinical Models: Detailed Specifications
For each clinical model, provide:
[Model Name]
Model Classification: [Clinical Model]
Reference: Reference to R-TF-028-001 section
Purpose
Describe the purpose of this model.
Input Specifications
| Parameter | Specification |
|---|---|
| Type | |
| Format | |
| Resolution | |
| Color Space |
Output Specifications
| Parameter | Specification |
|---|---|
| Type | |
| Dimension | |
| Data Type | |
| Range |
Output JSON Structure:
{
"example_field": "example_value"
}
Preprocessing Requirements
Describe the preprocessing steps required.
- Step 1
- Step 2
Post-processing Requirements
Describe the post-processing steps required.
- Step 1
- Step 2
Configuration File
File: model_config.json
{
"model_path": "",
"model_version": "",
"architecture": "",
"target_shape": [],
"normalization": {}
}
Performance Summary
| Metric | Result | 95% CI | Success Criterion |
|---|---|---|---|
Non-Clinical Models: Detailed Specifications
For each non-clinical model, provide the same structure as clinical models.
[Model Name]
Model Classification: [Non-Clinical Model]
Follow the same structure as clinical models.
Integration Guidelines
System Requirements
Describe the system requirements for running the models.
| Requirement | Specification |
|---|---|
| Runtime | |
| Memory | |
| GPU Support |
Deployment Architecture
Describe the deployment architecture.
Error Handling
Describe error handling requirements.
Logging and Monitoring
Describe logging and monitoring requirements.
Version Control and Traceability
Model Versioning
Describe the versioning scheme.
Change Log
| Version | Date | Changes |
|---|---|---|
Validation Checklist
Reference the AI V&V Checks (R-TF-028-010).
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: JD-009
- Reviewer: JD-009
- Approver: JD-005