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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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