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The VMS system is an adjunct to existing ultrasound imaging systems and is intended to record. analyze. store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS system is used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.

The VentriPoint Diagnostic System is a client/server platform consisting of the VentriPoint Medical System (client) and VentriPoint Services (server). The VentriPoint Medical System (VMS) is a cart based system consisting of CE Marked off-the-shelf subassemblies which accepts the digital video output from any 2-D ultrasound machine. A 3-D tracking system is connected to the ultrasound transducer using a custom sleeve. This system provides 3-D spatial coordinates for the 2-D images. After recording the 2-D images and associated 3-D spatial coordinates. a trained medical professional uses the VMS graphical user interface to place a series of points on the 2-D images corresponding to selected anatomical structures. Those points. along with their 3-D spatial coordinates, are sent bv secure internet connection to the VentriPoint Services. The VentriPoint Services use a Knowledge Based Reconstruction expert system to convert those 3-D points into a dense 3-D model of the right ventricle and sends the model back to the VMS svstem where the results are displayed on the screen. This initial rendering is reviewed for accuracy by the product user. The border contours generated from the previously placed points are displayed and may be adjusted by the user to achieve a precise fit. Improvements are made by adding. deleting or moving points on the image slices where needed. after which the information is sent by secure internet connection to the VentriPoint Services to be reconstructed. The review and reconstruction process may be repeated until the user is satisfied that the best contour fit has been made. Once the 3-D model has been approved by credentialed site personnel, quantitative right ventricle measurements are reported. The data produced by VMS is intended to support qualified licensed medical professionals in clinical decision making when used in conjunction with other patient test information.

The VentriPoint Medical System (VMS) is intended to record, analyze, store, and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is used to record a sequence of conventional cardiac 2-D ultrasound images with transducer position recorded to compute right ventricular volumes and ejection fraction. The system identifies anatomic landmarks, transmits them to a VMS server for 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension using Knowledge Based Reconstruction (KBR), and then returns the results for display and evaluation.

Here's an analysis of the acceptance criteria and study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity). However, the study aims to assess the accuracy of RV volumes and EF obtained with the VMS system compared to Cardiac Magnetic Resonance Imaging (MRI). The conclusion states that the VMS system is an accurate method of measuring RV volume and EF when compared with MRI analyzed using Simpson's method, implying that the performance met an internal or implicit accuracy standard.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: A clinical study was conducted with 75 consenting adults with Pulmonary Arterial Hypertension.
• Data Provenance: The data was collected from prospective clinical study participants. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study likely took place in the U.S. or under U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience). It mentions:

• "Analysis of the patient imaging data was completed by independent imaging core labs." This implies that qualified professionals were involved in analyzing the MRI data for ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method beyond stating that "Analysis of the patient imaging data was completed by independent imaging core labs." This suggests that the core labs provided the ground truth measurements. It does not mention multiple readers, consensus meetings, or other specific adjudication processes like 2+1 or 3+1.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this summary. The study focused on the standalone performance of the VMS system against a standard of care (MRI). The document does not describe human readers using the AI with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The clinical study assessed "the accuracy of right ventricle (RV) volumes and ejection fraction (EF) obtained with the VMS system" by comparing "Analysis of the patient imaging data... completed by independent imaging core labs" using Cardiac Magnetic Resonance Imaging (MRI) as the comparator. This indicates that the VMS system's output (an algorithm-driven result after user contouring) was directly compared to the ground truth.

7. Type of Ground Truth Used

The ground truth used was Cardiac Magnetic Resonance Imaging (MRI) analyzed using Simpson's method. MRI is considered a gold standard for cardiac chamber quantification.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set for the Knowledge Based Reconstruction (KBR) expert system.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established for the Knowledge Based Reconstruction (KBR) system. It only states that the VMS system uses a "Knowledge Based Reconstruction expert system" and makes a comparison to Siemens' "Knowledge Based Reconstruction database (only Velocity Vector Imaging (VVI) component)." This implies that the KBR system would have been developed using a dataset with known RV volumes and EF values, likely derived from methods like MRI or other established volumetric measurements, but the specifics are not detailed.

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