Search Results

The Emory Cardiac Toolbox™ 4.0 – 4.3 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered back projection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.

The Emory Cardiac Toolbox™ 4.3 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies.

The Emory Cardiac Toolbox™ 4.3 device's performance validation is described in section 8 of the provided document. The device includes two main new features: Emory-CACS for calcium plaque evaluation and ECTb™ Strain for wall motion and thickening analysis using strain measurements.

Here's a breakdown of the acceptance criteria and study details for each feature:

1. Table of acceptance criteria and reported device performance:

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

• Emory-CACS:

  • Sample Size: 52 patients, 110 vessels with calcified plaques.
  • Data Provenance: Retrospective, as the lesions had been "previously scored by Emory radiologists." The country of origin is not explicitly stated but can be inferred as the U.S. (Emory is in Atlanta, GA).

• ECTb™ Strain Analysis:

  • Sample Size:
    • Low-risk cohort (for establishing normal limits): n=22
    • High-risk / CAD cohort (for validation): n=80
  • Data Provenance: Not explicitly stated whether retrospective or prospective, but clinical comparison tests are often retrospective utilizing existing patient data. Country of origin is not explicitly stated but can be inferred as the U.S. (Emory is in Atlanta, GA).

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

• Emory-CACS:

  • Number of experts: Not explicitly stated, but lesions were "previously scored by Emory radiologists." This implies at least one, and likely more, radiologists.
  • Qualifications: "Emory radiologists." Specific experience level (e.g., "10 years of experience") is not provided.

• ECTb™ Strain Analysis:

  • Number of experts: Not applicable in the same way as Emory-CACS, as the ground truth was established by another accepted reference standard (TTE echo).
  • Qualifications: Not applicable for establishing ground truth from experts, but rather from the TTE echo measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Emory-CACS: Not explicitly described. The text states lesions were "previously scored by Emory radiologists," suggesting consensus or a single expert's reading, but no formal adjudication method like "2+1" is mentioned.

• ECTb™ Strain Analysis: Not applicable, as the ground truth was established by an existing clinical measurement method (TTE echo), not by expert consensus on the device's output.

5. 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 focused on human reader improvement with AI assistance was not explicitly described for either new feature in this validation summary. The studies focused on comparing the device's performance directly against a predicate device or an accepted clinical reference standard.

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

• Yes, for both features, the validation described appears to be a standalone (algorithm only) performance assessment.
  • Emory-CACS: The module was compared directly against the SyngoVia™ module, analyzing the same lesions. This implies the device's output was generated and then compared to the predicate's output without human modification or interpretation of the device's results as part of the primary validation.
  • ECTb™ Strain Analysis: The PET MPI measurements (presumably generated by the ECTb™ Strain algorithm) were correlated with TTE echo measurements, which is a comparison of two different measurement modalities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Emory-CACS: The ground truth for the reference lesions was established by the "previously scored by Emory radiologists" and the output of the predicate device (Siemens SyngoVia™ toolbox). In essence, the predicate device's output served as the reference standard against which Emory-CACS was compared.

• ECTb™ Strain Analysis: The ground truth (reference standard) for strain measurements was established using Transthoracic Echocardiography (TTE echo), which is an accepted clinical reference standard for cardiac function assessment.

8. The sample size for the training set:

• The document does not explicitly state the sample size for the training set for either the Emory-CACS or ECTb™ Strain analysis features. The described methodology focuses solely on the validation/test sets used for performance assessment.

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

• Since the training set size and details are not provided, the method for establishing its ground truth is also not described in the document.

Ask a specific question about this device