SmartChest

“SmartChest is a radiological computer assisted triage and notification software that analyzes frontal chest X-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of transitional adolescents (18-21 yo but treated like adults) and adults (≥22 yo) for the presence of suspected pleural effusion and/or pneumothorax. SmartChest uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides case-level output available to a PACS (or other DICOM storage platforms) for worklist prioritization.”

“SmartChest uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides case-level output available to a PACS (or other DICOM storage platforms) for worklist prioritization. A structure of the CNN is then defined, which consists of different types of layers.”

“The collected data are used to train the model, adjusting its weights based on the errors it makes in predictions. To fine-tune the model and prevent it from overly specializing in the training data, a separate validation set is used. Finally, the model's performance is assessed with a testing set to see how well it can handle unseen data. Depending on the results, it is possible to go back and adjust the data, model's structure, or fine-tuning parameters, then repeat the training process until the model performs satisfactorily”

“Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."”