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DeepTek CXR Analyzer v1.0 is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious ROIs in one of the following categories: Lungs, Pleura, Cardiac, and Hardware. The device is intended for use as a concurrent reading aid for radiologists. DeepTek CXR Analyzer v1.0 is indicated for adults and transitional adolescents (18 to

DeepTek CXR Analyzer is a computer-assisted detection (CADe) software device developed to assist radiologists in identifying suspicious regions of interest (ROIs) in the following categories: Lungs, Pleura, Cardiac, and Hardware. DeepTek CXR Analyzer detects suspicious ROIs by analyzing adult frontal chest radiographs using deep learning algorithms and provides relevant annotations to assist radiologists with their interpretations.

The device has an authentication graphical user interface, which allows the user to authenticate themselves. The user can connect the PACS with the DeepTek CXR Analyzer using the configuration interface. The user can enter the PACS AE Title, IP address, Listener and Sender Port number to configure the device. Once the device is configured correctly, DeepTek CXR Analyzer receives chest radiographs from the configured PACS in DICOM format as input. DeepTek CXR Analyzer identifies suspicious ROIs in the following categories: Lungs, Pleura, Cardiac, and Hardware, and sends the secondary capture DICOM with AI output to the same PACS over the DICOM protocol. The output DICOM File Processing component creates a DICOM image containing the original radiograph with a message stating that the image was analyzed by DeepTek CXR Analyzer (with information containing manufacturer name, product name, product version, and a link to user manual) and color-coded bounding boxes containing suspected ROIs. If no suspicious ROIs are detected in the image, the output will not contain any bounding boxes and will have a message stating "No Suspicious ROI(s) Detected". In the event of any type of failure in the workflow, a human-readable error message representing the type of failure will be logged in the Logs interface.

DeepTek CXR Analyzer does not make treatment recommendations or provide a diagnosis. Radiologists should review images annotated by DeepTek CXR Analyzer concurrently with original, unannotated images before making the final decision on a case. DeepTek CXR Analyzer is an adjunct tool and does not replace the role of the radiologists. The CAD-generated output should not be used as the primary interpretation by radiologists.

DeepTek CXR Analyzer has been trained using a large and diverse dataset of more than 100,000 chest X-ray images sourced from 30 distinct sites from India, including medical imaging centers, data partners, and medical hospitals, and over 15 different modality manufacturers. The inclusion of such a diverse range of data ensures that the performance of the DeepTek CXR Analyzer generalizes to a wide variety of confounders.

DeepTek CXR Analyzer is not designed to detect conditions other than those classified under the following categories: Lung, Cardiac, Pleura, and Hardware. Radiologists should review original images for all suspected ROIs.

Here's a breakdown of the acceptance criteria and study details for the DeepTek CXR Analyzer v1.0, based on the provided FDA 510(k) submission document:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the performance metrics of the standalone assessment and the clinical performance assessment. The document states that the device's performance was evaluated by measuring sensitivity, specificity, AUROC (Area Under the Receiver Operating Characteristic curve) for detection, and wAFROC-FOM (weighted Alternative Free-Response Receiver Operating Characteristic Figure of Merit) for localization. For the clinical study, the primary objective was to demonstrate that the wAFROC-FOM for aided readings was superior to unaided readings.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance (Standalone)

Table 2: Acceptance Criteria (Implied) and Reported Device Performance (Standalone Localization)

Table 3: Acceptance Criteria (Clinical Study Null/Alternate Hypothesis) and Reported Device Performance (Clinical Study)

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