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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 indicated for use where RV volumes and ejection fractions are warranted or desired.

The VentriPoint Medical System was cleared under 510(k) K140153 for use in adult patients with Pulmonary Arterial Hypertension. This current submission is intended to expand system use to right ventricle evaluation where RV volumes and ejection fractions are warranted or desired in patients other than those diagnosed with PAH. Right ventricle evaluation is accomplished by the addition of a KBR heart catalog containing a variety of heart models that are not specific to PAH. All other system operational characteristics remain unchanged from the cleared device.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the submission as an expansion of use for the VentriPoint Medical System (VMS) to include a new "RV catalog" for evaluating right ventricle volumes and ejection fractions in patients beyond those diagnosed with Pulmonary Arterial Hypertension (PAH). The primary claim is substantial equivalence to the previously cleared device (K140153).

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum accuracy percentages, specific Bland-Altman limits of agreement) for the expanded use. Instead, it relies on the comparison to the existing predicate device and the rigor of the nonclinical testing for the new RV catalog.

However, we can infer the guiding principle for acceptance:

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

• Test Set for K150628 (Expanded Use): The document states, "Performance bench testing of the RV catalog was completed..." and "Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy."

  • Sample Size: The specific number of cases or data points used in this "robust series of automated and manual testing" for the RV catalog is not specified in the provided text.
  • Data Provenance: This was nonclinical bench testing, meaning it likely involved simulated data, phantoms, or possibly previously acquired anonymized patient data used in a controlled laboratory setting. The document does not specify country of origin for this bench testing data. It is neither prospective nor retrospective clinical data.

• Test Set for K140153 (Predicate Device Clinical Testing):

  • Sample Size: The document refers to "Prior clinical testing was completed in adult Pulmonary Arterial Hypertension (PAH) patients which was the basis for pre-market notification K140153." The specific sample size for this clinical testing is not provided in this document.
  • Data Provenance: This was "clinical testing" in "adult Pulmonary Arterial Hypertension (PAH) patients." The country of origin is not specified, and it would have been prospective or retrospective clinical data related to PAH patients.

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

• For K150628 (Bench Testing for New RV Catalog): The document mentions "automated and manual testing to verify reconstruction accuracy." It does not explicitly state the involvement of human experts for establishing ground truth during this specific bench testing. If manual verification was performed, it would imply human review, but the number and qualifications are not specified.
• For K140153 (Clinical Testing for Predicate Device): The ground truth for the predicate device's clinical testing was "volumes derived from cardiac MRI." While cardiac MRI interpretation requires expert radiologists/cardiologists, the document does not specify the number of experts or their qualifications used to establish these MRI-derived ground truth values.

4. Adjudication Method:

• For K150628 (Bench Testing for New RV Catalog): The document describes "robust series of automated and manual testing." An explicit adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in manual testing, if any, is not specified.
• For K140153 (Clinical Testing for Predicate Device): Not specified.

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

• No, a MRMC comparative effectiveness study was not explicitly mentioned or described for either the current submission (K150628) or the predicate (K140153) in the provided text.
  • The K140153 clearance "demonstrated the substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI." This suggests a comparison of the algorithm's performance to a gold standard, rather than a study comparing human readers with and without AI assistance.
  • For K150628, the justification for not conducting additional human clinical trials was that the RV catalog development was similar to the PAH catalog and that extensive bench testing was performed.

6. Standalone ("Algorithm Only") Performance Study:

• Yes, standalone performance was implicitly studied.
  • "Performance bench testing of the RV catalog was completed to verify suitability for right ventricle evaluation..." and "Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy." This describes evaluating the algorithm's output directly against some form of ground truth or benchmark during bench testing.
  • Similarly, the K140153 clearance involving "substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI" represents a standalone performance evaluation of the algorithm against a clinical gold standard. The device's description clarifies it's "computerized 3-dimensional image processing" and uses "Knowledge Based Reconstruction (KBR)" via a server, indicating an algorithmic analysis.

7. Type of Ground Truth Used:

• For K150628 (New RV Catalog Bench Testing): The ground truth for the bench testing was derived from methods used to "verify reconstruction accuracy" through "automated and manual testing." The exact nature (e.g., synthetic phantoms with known volumes, highly curated images with expert annotations) is not detailed, but it's related to the "Knowledge Based Reconstruction database."
• For K140153 (Predicate Device Clinical Testing): The ground truth was volumes derived from cardiac MRI. Cardiac MRI is generally considered a gold standard for cardiac chamber volume measurements.

8. Sample Size for the Training Set:

• The document mentions "Development of the RV catalog was conducted according to VentriPoint established procedures in the same way as the PAH catalog that was cleared as part of K140153." and refers to a "KBR heart catalog containing a variety of heart models."
• The specific sample size of data used to train or develop the "KBR heart catalog" or "RV catalog" is not provided in the document.

9. How Ground Truth for Training Set Was Established:

• The document mentions "Knowledge Based Reconstruction (KBR)" and the "KBR heart catalog." The KBR system fundamentally relies on a database of heart models. How these initial heart models and their associated ground truth (e.g., precise anatomical measurements, volumes) were established for the training/development of the original KBR system and the new RV catalog is not detailed in this summary. It would likely involve meticulously characterized anatomical data, potentially from diverse sources (e.g., cadaveric studies, high-resolution imaging modalities with expert segmentation).

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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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