Your Name:
Name of your Device:
Intended Use Statement:
Indications for Use:
Device Limitations:
Clinical Impact of Performance:
<< Insert Algorithm Flowchart >>
DICOM Checking Steps:
Preprocessing Steps:
CNN Architecture:
Parameters:
- Types of augmentation used during training
- Batch size
- Optimizer learning rate
- Layers of pre-existing architecture that were frozen
- Layers of pre-existing architecture that were fine-tuned
- Layers added to pre-existing architecture
<< Insert algorithm training performance visualization >>
<< Insert P-R curve >>
Final Threshold and Explanation:
(For the below, include visualizations as they are useful and relevant)
Description of Training Dataset:
Description of Validation Dataset:
Patient Population Description for FDA Validation Dataset:
Ground Truth Acquisition Methodology:
Algorithm Performance Standard: