qXR-PTX-PE
qXR-PTX-PE is standalone software designed to aid in triaging chest X-rays for the presence of pneumothorax and pleural effusion.
- Chest X-Ray Analysis
- Pneumothorax effusion
- Pleural Effusion
- Image Analysis
Chest X-Ray Image Analysis
qXR-PTX-PE consists of a set of deep learning algorithms that have been trained to analyze chest X-rays taken from both anterior-posterior (AP) and posterior-anterior (PA) views. The software provides case-level outputs for worklist prioritization or triage. Additionally, it generates passive notification flags for scans indicating the presence of pneumothorax or pleural effusion.
Technical Specifications and Operational Capabilities
- qXR-PTX-PE interacts with the user's PACS to receive de-identified scans and return results to the same destination.
- The software is designed to run in 'always-on' mode on dedicated hardware.
- Provides output in Secondary Capture (SC), Greyscale Presentation (GSPS), PDF report, PDF Embedded DICOM, Structured Report (SR), HL7, and JSON formats.
- qXR-PTX-PE employs a two-dimensional classification convolutional neural network (2D CNN) to determine the probability that a pneumothorax and/or pleural effusion is present in each x-ray.
- The software uses a prefixed threshold on the CNN output to provide a binary (yes/no) output for each condition.
- qXR-PTX-PE's algorithm was trained on data from various regions, including India (74%), EU (20.04%), US (3.9%), Brazil (1.4%), and Vietnam (0.63%).
- It’s input are frontal chest X-rays (AP and PA view) in DICOM format.
qXR-PTX-PE achieved an AUC of 0.989 (95% CI: 0.983-0.998) for pneumothorax detection with sensitivity of 94.53% and specificity of 96.36% in a study of 613 chest X-rays (201 with and 412 without pneumothorax).
qXR-PTX-PE achieved an AUC of 0.989 (95% CI: 0.985-0.994) for pleural effusion detection with sensitivity of 96.22% and specificity of 94.90% in a study of 1070 chest X-rays (344 with and 726 without pleural effusion).
Integration. Security.
For use with CR/DR/DX modalities.
For use with de-identified DICOM (.dcm) images.
Requires a minimum image dimension of 1440*1440 pixels and 10 gray level bits.
qXR-PTX-PE integrates with hospital PACS systems.
Utilizes access enforced firewalls, VPN, and two-factor authentication for system protection.
qXR-PTX-PE systems receive regular security patches for operating systems, applications, and modules.
Intended Use
- For use with adult chest X-ray images (age ≥ 22 years).
- qXR-PTX-PE provides case-level output for worklist prioritization or triage.
- qXR-PTX-PE does not send proactive alerts directly to medical specialists.
- qXR-PTX-PE is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax.
- It’s results are not intended to be used on a stand-alone basis for clinical decision-making.
Intended Users
- The intended users of qXR-PTX-PE are clinicians, and other appropriately trained medical specialists qualified to read chest radiographs.
1qXR-PTX-PE User Guide. Software Version V 1.0
6230899 (qXR-PTX-PE). US Food and Drug Administration. Silver Spring, MD, 2023.
