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CaRi-Plaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

CaRi-Plaque is a web-based image processing application. It is a non-invasive diagnostic reading software intended for use as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary plaques and luminal stenoses.

CaRi-Plaque is intended for use by internal operators who have been appropriately trained in the software's functions, capabilities and limitations.

Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology may be present that is near or smaller than the scanning resolution.

The analysis results produced by the software and provided to the Healthcare Professional are not intended to replace the skill and judgment of a qualified medical practitioner. The analysis results should be reviewed with other clinical information which may include but is not limited to: The patient's original CT images, clinical history, symptoms, clinical risk factors, results of other diagnostic tests, and the clinical judgement of appropriately qualified Healthcare Professionals.

CaRi-Plaque v1.0 ("CaRi-Plaque," the subject device) is a web-based software-only application for the quantitative and qualitative clinical analysis of previously acquired CCTA DICOM data for the purpose of characterizing and quantifying plaque formation and stenosis in coronary arteries. CaRi-Plaque aids healthcare professionals trained in cardiovascular health and patient care (including but not limited to Cardiologists, Radiologists and others) by describing the physical characteristics of coronary plaque volume and cross- sectional area, determined using a combination of 3D image thresholding computerized algorithms and manual editing tools to provide automated quantification and characterization of coronary atherosclerotic plaque and stenosis. The processing of CT scan data is performed by trained operators and the resulting CaRi-Plaque Report is provided to the healthcare professional to enable them to assess the extent and severity of coronary disease.

The CaRi-Plaque report includes visual representations of each vessel and associated quantitative outputs. These quantitative outputs include: Plaque Burden, Calcified Plaque (CP) Volume, Total Plaque Volume, Noncalcified Plaque (NCP) Volume, Low Density Noncalcified Plaque (LD-NCP) Volume, Remodeling Index, and Maximum Stenosis. CaRi-Plaque does not replace standard clinical practice or clinical decisionmaking, and the results of the CaRi-Plaque analysis are to be used in the context of other patient information by the healthcare professional. The healthcare professional may request a re-analysis of the CT scan data if they do not agree with the report analysis.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

• Total Plaque Volume: 0.958
• Calcified Plaque Volume: 0.964
• Noncalcified Plaque Volume: 0.953
• Plaque Burden: 0.924
• Low Density Noncalcified Plaque Volume: 0.633
• Remodeling Index: 90.3% (K=0.31) |
  | Branch-level Pearson Correlation Coefficients (or Cohen's Kappa for Remodeling Index) for LAD, D1, D2, Ramus: | - Maximum Stenosis: 0.929
• Total Plaque Volume: 0.959
• Calcified Plaque Volume: 0.997
• Noncalcified Plaque Volume: 0.942
• Plaque Burden: 0.913
• Low Density Noncalcified Plaque Volume: 0.802
• Remodeling Index: 87.2% (K=0.44) |
  | Branch-level Pearson Correlation Coefficients (or Cohen's Kappa for Remodeling Index) for LCX, OM1, OM2: | - Maximum Stenosis: 0.911
• Total Plaque Volume: 0.948
• Calcified Plaque Volume: 0.991
• Noncalcified Plaque Volume: 0.934
• Plaque Burden: 0.888
• Remodeling Index: 90.3% (K=0.31)
  (Note: Insufficient low density non-calcified plaque in these branches to generate a meaningful correlation, thus no coefficient is reported for this specific metric.) |
  | Inter-operator agreement and repeatability | Good inter-operator agreement and repeatability at the branch level within the CaRi-Plaque device arm and between readers in the Ground Truth arm. |

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: 117 subjects (85 men, 32 women) aged 27 to 85 years of age.
   • Data Provenance: Multi-center, international patient population from four (4) sites (2 US and 2 OUS - Outside US).
     • Individual subject-level ethnicity for 57 subjects: White 76%, Asian 4%, Middle Eastern 1%, other 14%, and unknown 5%.
     • Ethnicity for the remaining 60 subjects (48 subjects from one site, 12 from another) was estimated from local population census data (www.census.gov). For the first site: White (not Hispanic or Latino) 44%, Black 22%, Hispanic or Latino 27%, and Asian 5%; for the second site: White (not Hispanic or Latino) 46%, Black 19%, Hispanic or Latino 26%, and Asian 13%.
     • CT scanners used included commercial CT scanners from Toshiba, GE, Phillips, and Siemens.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states "qualified independent medical experts performed ground truthing." It does not specify the exact number of experts or their specific qualifications (e.g., number of years of experience, subspecialty).

3. Adjudication method for the test set:

   • The document describes "agreement between the expert readers and the CaRi-Plaque device measurements." It does not explicitly state an adjudication method like 2+1 or 3+1 for resolving discrepancies among expert readers themselves, but rather refers to them collectively for "ground truth".

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI assistance versus without AI assistance was not mentioned or reported. The study focused on the agreement between the device's measurements and expert-determined ground truth.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the clinical validation study measured the agreement between the CaRi-Plaque device measurements (algorithm's output) and expert-determined ground truth. This indicates a standalone performance evaluation of the algorithm against the established ground truth. The device is described as "aid[ing] healthcare professionals" and its results are "provided to the Healthcare Professional," implying the algorithm works standalone to produce these measurements for subsequent review.

6. The type of ground truth used:

   • Expert Consensus / Expert Interpretation: The ground truth was "ground truth determined by qualified independent medical experts." This implies expert consensus or interpretation was used.

7. The sample size for the training set:

   • The document does not specify the sample size for the training set. It only describes the clinical validation study (test set).

8. How the ground truth for the training set was established:

   • The document does not specify how the ground truth for the training set was established, as information about the training set itself is not provided.

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