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qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage.

As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not send a proactive alert directly to the appropriately trained 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. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

qXR-PTX-PE is a radiological computer aided triage and notification software that analyses adult frontal (AP or PA views) CXR images for the presence of pre-specified suspected target conditions (pleural effusion and/or pneumothorax). The algorithm was trained on training data from across the world. The training dataset consisted of 74% of the data from India, 20.04% from the EU, 3.9% from the US, 1.4% from Brazil and 0.63% from Vietnam. The input for qXR-PTX-PE is a frontal chest X-ray (AP and PA view) in digital imaging and communications in medicine (DICOM) format

Chest X-rays are sent to qXR-PTX-PE by the means of transmission within the user's image storage system (e.g., Picture Archiving and Communication System (PACS)) or other radiological imaging equipment (e.g., X-ray systems) and processed by the qXR-PTX-PE for analysis. Following receipt of chest radiographs, the software device automatically analyses each image to detect features suggestive of pneumothorax and/or pleural effusion.

This would allow the appropriately trained medical specialists to group suspicious exams together that may potentially benefit for their prioritization. Chest radiographs without the suspicious findings are placed in the worklist for routine review, which is the standard of care at present. A secondary capture is available for the information on presence of the suspicious findings.

qXR-PTX-PE does not provide any proactive alerts. qXR-PTX-PE is not intended to direct attention to specific portions of the image. The results are not intended to be used on a standalone basis for clinical decision-making nor is it intended to rule out the target conditions or otherwise preclude clinical assessment of X-Ray cases.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the statement: "The device shows > 95% AUC". The reported performance significantly exceeds this threshold.

2. Sample Size Used for the Test Set and Data Provenance

• Pneumothorax Test Set: 613 scans
  • 201 scans with pneumothorax
  • 412 scans without pneumothorax
• Pleural Effusion Test Set: 1070 scans
  • 344 scans with pleural effusion
  • 726 scans without pleural effusion
• Data Provenance: Retrospective. All test data was obtained from various hospitals across the US. Specific regions mentioned include Midwest, Northeast, and West. The test set was intentionally obtained from sites different from the training data sites to ensure independence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: 3
• Qualifications: ABR (American Board of Radiology) thoracic radiologists with a minimum of 10 years of experience.

4. Adjudication Method for the Test Set

The provided text states that "The ground truth was established by 3 ABR thoracic radiologists with a minimum of 10 years of experience." It does not specify a particular adjudication method (e.g., 2+1, 3+1, or simple consensus). Without further detail, it's assumed to be a consensus among these three experts, but the exact process of resolving discrepancies is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported. The study focuses purely on the standalone performance of the AI algorithm (qXR-PTX-PE) and compares it to the standalone performance of a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The reported AUC, sensitivity, and specificity metrics are for the qXR-PTX-PE algorithm acting independently.

7. The Type of Ground Truth Used

The ground truth used was expert consensus (3 ABR thoracic radiologists with a minimum of 10 years of experience).

8. The Sample Size for the Training Set

The exact total sample size for the training set is not specified. However, the text provides the geographical distribution of the training data:

• 74% from India
• 20.04% from the EU
• 3.9% from the US
• 1.4% from Brazil
• 0.63% from Vietnam

9. How the Ground Truth for the Training Set was Established

The document does not explicitly state how the ground truth for the training set was established. It only mentions that the algorithm was "trained on training data from across the world." It can be inferred that expert labeling or clinical diagnoses were likely used, given the nature of a medical imaging AI, but specific details about the process (e.g., number of readers, their qualifications, adjudication) are not provided for the training data.

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