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FDA Submission

Your Name: Josip Vrdoljak

Name of your Device: Pneumonia detection algorithm

Algorithm Description

1. General Information

Intended Use Statement: Assisting clinitians in pneumonia detection

Indications for Use: Screening for pneumonia in patients aged 20-80 years, at Infectious disease and Respiratory disease emergency rooms

Device Limitations: ROC-AUC of 0.77. Worse sensitivity in the preseance of infiltrations.

Clinical Impact of Performance: Faster screening times, can help doctors in the triage of patients

2. Algorithm Design and Function

<< Insert Algorithm Flowchart >>

DICOM Checking Steps: - check wether the image is AP or PA

Preprocessing Steps: - resized images and performed image augmentation

CNN Architecture: - VGG 16 first 16 layers + 1 final dense layer with a sigmoid activation function

3. Algorithm Training

Parameters:

  • ImageDataGenerator function for Keras was used for augmentation
  • Batch size: 32
  • Optimizer learning rate: 1e-4
  • Layers of pre-existing architecture that were frozen: 16
  • Layers of pre-existing architecture that were fine-tuned: 0
  • Layers added to pre-existing architecture: 1

<< Insert algorithm training performance visualization >>

<< Insert P-R curve >>

Final Threshold and Explanation: We picked 0.64 as an optimal threshold based on the P-R curve

4. Databases

(For the below, include visualizations as they are useful and relevant)

Description of Training Dataset: 2290 images extracted and augmented from the NIH chest x-ray dataset

Description of Validation Dataset: 1390 images extracted and augmented from the NIH chest x-ray dataset Both datasets were confirmed to have the same distributions of the target variable (pneumonia)

5. Ground Truth

Was established via radiologist findings.

6. FDA Validation Plan

Patient Population Description for FDA Validation Dataset: Patients that are suspected to have pneumonia

Ground Truth Acquisition Methodology: radiologist finding

Algorithm Performance Standard: AUC of 0.77