(161 days)
PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning.
The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes.
The information provided by PrecisionTAVI is intended for use by cardiologists, and clinical specialists, and is not intended in any way to eliminate, replace, or substitute for, in part, the healthcare provider's judgment and analysis of the patient's condition receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions.
PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.
DASI Simulations PrecisionTAVI is a computer simulation device that predicts implant frame deformation after implantation of a Transcatheter Heart Valve (THV) device. The simulation combines a predefined THV device model and size with a patient-specific model of the patient's anatomy thereby predicting the post deployment deformation of the THV and the anatomy. The simulation results are intended to be used by qualified clinicians as additional information for planning transcatheter aortic valve replacement (TAVR).
PrecisionTAVI conducts TAVR device deployment simulation using proprietary computational modeling technology.
The input for the simulation is a 3D model of the patient anatomy. The 3D model is generated from 2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography).
The simulation output is a report with 3D visualization capability to depict the predicted deformed THV in the deformed patient-specific anatomy of the aortic valve and root.
The 3D model generation and the report generation from the simulation is performed by trained operators at DASI Simulations using an established workflow. The report is accessible to the end user as a download from the DASI Simulations portal with a standard web browser.
Here is a summary of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quantitative Validation (THV Deformation) | ||
| Mean THV diameter (inflow, waist, outflow regions) | 80% agreement in clinician qualitative assessments. (Though specific criteria were described as "close agreement with the clinical outputs" across various views, the overall acceptance was >80%) | 96% of all case evaluations (48/50) were found to be in agreement, with 90.5% (181/200) cut planes testing successfully. |
| Conclusion: Satisfied. | ||
| Qualitative Validation (Engineer Assessment) | > 80% agreement in engineer qualitative assessments. (Specifically for eccentricity and apposition of the THV stent) | - Eccentricity: 97% of cases found in agreement. |
- Apposition: 99% of cases found in agreement.
Conclusion: Satisfied. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 89 patients.
- Data Provenance: The data was derived from clinical deployments. Patients had tricuspid aortic valve morphology, received a SAPIEN S3/Ultra THV, and had both pre-TAVR and post-TAVR CT imaging available. The specific country of origin is not explicitly stated, but it's implied to be clinical data. It is retrospective as it uses pre-existing clinical deployment data (pre-TAVR and post-TAVR CT images).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts:
- Quantitative Ground Truth: No external experts were used; ground truth was established by reconstructing THV geometries directly from post-operative clinical CT image data.
- Qualitative Ground Truth:
- Five (5) experienced independent clinicians in the TAVR space.
- Three (3) trained DASI Simulations engineers.
- Qualifications of Experts:
- Clinicians: "Experienced independent clinicians in the TAVR space." (Specific years of experience or other detailed qualifications not provided).
- Engineers: "Trained DASI Simulations engineers." (Specific qualifications not provided beyond being "trained").
4. Adjudication Method for the Test Set
- Quantitative: Not applicable, as ground truth was derived directly from post-operative clinical CT images for quantitative measurements.
- Qualitative: Not explicitly stated as a formal adjudication method like '2+1' or '3+1'. However, clinicians and engineers were individually presented with comparison image pairs and asked to state if they found the simulated outputs to be "in close agreement" with the clinical outputs. The overall percentage of agreement was then reported. It does not appear there was a consensus or tie-breaking process explicitly described for individual cases, but rather an aggregate assessment of agreement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not reported. The study focused on the performance of the AI device itself (standalone and qualitative assessment), not on how human readers improved with or without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done.
- Quantitative Validation: The device's predicted THV deformation (diameter and aspect ratio) was compared directly against measurements derived from post-TAVR CT images.
- Qualitative Validation: Clinicians and engineers assessed the "close agreement" between the device's simulated outputs and clinical post-procedural images. Both of these are examples of standalone performance evaluation.
7. Type of Ground Truth Used
- Quantitative Validation: The ground truth for quantitative measurements (THV diameter and aspect ratio) was derived from post-operative clinical CT image data. This is essentially "outcomes data" in the sense that it represents the actual, measured post-TAVR state in patients.
- Qualitative Validation: The ground truth for qualitative assessments was also the post-operative clinical images (clinical outputs), against which the simulated outputs were compared by clinicians and engineers.
8. Sample Size for the Training Set
- The document does not provide information regarding the sample size for the training set. It only mentions the test set of 89 patients.
9. How the Ground Truth for the Training Set Was Established
- As the training set sample size is not provided, the method for establishing its ground truth is also not specified in the document.
§ 870.1405 Interventional cardiovascular implant simulation software device.
(a)
Identification. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient's cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications.
(2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use.
(3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following:
(i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations;
(ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range (
e.g., full range of patient population, implant device sizes and patient anatomic morphologies). Any selection criteria or limitations of the samples must be described and justified;(iii) Endpoints (
e.g., performance goals) and sample sizes established must be justified as to how they were determined and why they are clinically meaningful; and(iv) Validation must be performed and controls implemented to characterize and ensure consistency (
i.e., repeatability and reproducibility) of modeling outputs:(A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; and
(B) The factors (
e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data.(4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information.
(5) Device labeling must be provided that describes the following:
(i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results;
(ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and
(iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance.