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FEops HEARTguide is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.

The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.

FEops HEARTguide is intended to be used by qualified clinicians in conjunction with the simulated device instructions-for-use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.

FEops HEARTguide is not intended to replace the simulated device's instructions for use for final LAAO device selection and placement.

FEops HEARTguide is prescription use only.

FEops HEARTguide is a computer simulation device which provides a prediction of implant frame deformation (device-tissue interaction) post transcatheter LAAO device implantation. The device performs simulation by combining a predefined device model with a patient-specific model of the patient anatomy (Figure 1). The simulation results are intended to be used by qualified clinicians as a pre-procedural planning adjunct for LAAO implantation.

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

Acceptance Criteria and Reported Device Performance

Study Details for Clinical Accuracy Validation

1. Sample Size and Data Provenance

• Test Set Sample Size: 60 retrospective Watchman left atrial appendage occlusion (LAAO) cases.
• Data Provenance: Retrospective, from 5 centers. The specific country of origin is not explicitly stated, but the sponsor is based in Belgium.

2. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 cardiology experts.
• Qualifications: Referred to as "cardiology experts." No further specific details on years of experience or board certification are provided in the text.

3. Adjudication Method

• Adjudication Method: Not explicitly detailed as 2+1 or 3+1. The text states that "3 cardiology experts rated the similarity." It implies a consensus or majority rule for the qualitative endpoint, as 90.6% of the grades (plural) were "acceptable" or better. It doesn't specify if discrepancies were resolved.

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

• MRMC Study Done? No, a traditional MRMC comparative effectiveness study where human readers' performance with and without AI assistance is compared was not reported. The study focused on the accuracy of the device simulation's output compared to observed data and expert qualitative assessment of that output.
• Effect Size of Human Improvement (if applicable): Not applicable, as this type of MRMC study was not performed.

5. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the study evaluates the performance of the FEops HEARTguide software in predicting device deformation without direct human-in-the-loop assistance during the simulation process. The experts evaluate the output of the simulation.

6. Type of Ground Truth Used

• Quantitative Ground Truth: Actual Watchman deformation observed on post-operative cardiac CT, measured by the maximum device diameter (Dmax).
• Qualitative Ground Truth: Geometry reconstructed from post-operative CT images, against which the simulated deployed device visualization was compared by cardiology experts.

7. Training Set Sample Size

• The text does not explicitly state the sample size for the training set. It mentions training, but not specific numbers for a "training set" in the context of a machine learning model. The "Model Development" section describes the creation of the computational models and material validation, but does not detail a separate training set for an AI/ML algorithm in the typical sense. It implies the model was developed based on CAD files and expansion tests from the manufacturer, and pre/post-operative CT images for material validation, but these "datasets" were not re-used in the clinical validation, suggesting they might have been part of development/training.

8. How Ground Truth for Training Set was Established

• As the training set size is not explicitly stated in the context of an AI/ML algorithm, the method for establishing its ground truth is also not detailed.
• For material validation (which could be considered analogous to part of model development/training), the text states: "Material properties validation of the LAA soft tissue used in the patient-specific simulations. This was achieved using datasets consisting of pre- and post-operative CT images." This implies the "ground truth" for material properties came from the observed changes between pre- and post-operative CT images. The "Implant Device Model" validation used "expansion tests received from the manufacturer" to validate the material model based on CAD files.

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