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The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes caselevel output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.

The AIMI-Triage CXR PTX Application is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review, and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. Notified radiologists are responsible for engaging in appropriate patient evaluation as per local hospital procedure before making care-related decisions or requests. The device does not replace review and diagnosis of the X-rays by radiologists. The device is not intended to be used with plain film X-rays.

The AIMI-Triage CXR PTX provides a chest X-ray prioritization service for use by radiologists to identify features suggestive of moderate to large sized pneumothorax. The artificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review. X-rays without an identified anomaly are placed in the worklist for routine review, which is the current standard of care. The user interface is minimal, consisting of the radiologist's existing picture archiving and communication system (PACS) viewer and worklist in which positively identified images are flagged by the software to notify of the suspected anomaly. Images are not marked or otherwise altered, and no diagnoses are provided.

The device does not have any direct accessories. However, it interacts with hospital communication and database systems in order to read and analyze cases in the worklist of the hospital's PACS system in order to identify suspected abnormal findings and transmit corresponding notifications to reflect its recommended prioritization of patient examinations for radiologist review. The software output is compatible with any PACS viewer and worklist.

Acceptance Criteria and Study Details for AIMI-Triage CXR PTX

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 300 frontal chest X-rays (PA/AP).
• Data Provenance: Collected from US and OUS (Outside US) patients, representative of the intended population. The datasets are specifically identified as NIH (US) and PADCHEST (OUS). The study was retrospective.
  • Patient Demographics: 168 (56%) male with mean age 51.6 years (SD=18.6, range 18-91), and 132 (44%) female with mean age 51.8 years (SD=16.2, range 23-86).

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

• Number of Experts: 3 independent radiologists.
• Qualifications: US-board certified radiologists.

4. Adjudication Method for the Test Set

• The ground truth was established by 3 independent US-board certified radiologists.
• Each "Truther" involved in the ground truthing process was blinded to any other Truther's results, to any existing report, and to the results obtained by the AIMI-Triage CXR PTX software. This implies that the ground truth was established by individual assessment and likely involved a consensus or majority vote among the 3 radiologists, although the specific "2+1" or "3+1" method is not explicitly stated. The emphasis on independent and blinded assessment supports a robust adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• It is not explicitly stated that an MRMC comparative effectiveness study was done to measure human reader improvement with AI assistance. The study focuses on standalone AI performance compared to a ground truth established by experts.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted. The "AIMI-Triage CXR PTX output was compared to the ground truth established by 3 independent US-board certified radiologists." This indicates the algorithm's performance without direct human-in-the-loop assistance during the evaluation.

7. Type of Ground Truth Used

• Expert Consensus: The ground truth was established by "3 independent US-board certified radiologists." While "consensus" isn't explicitly used, the involvement of multiple blinded experts suggests a robust process to define the true positive/negative cases.

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only mentions that the artificial intelligence algorithm was "trained via pattern recognition."

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

• The document does not specify how the ground truth for the training set was established. It only indicates that the algorithm was "trained via pattern recognition."

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