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The Emory Cardiac Toolbox™ (CEqual®, EGS™) 2.0 software program should be used for the quantification of myocardial perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated Tc99m SPECT myocardial perfusion studies (EGS™).

The Emory Cardiac Tool Box™ 2.0 is used to display gated wall motion and for quantifying parameters of left-ventricular from gated SPECT myocardial perfusion studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass and transient ischemic dilatation (TID). In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, expert system image interpretation, and patient specific 3D coronary overlay. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports IDL and the Aladdin (General Electric) software development . The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

The provided document details the 510(k) summary for the Emory Cardiac Tool Box™ 2.0. Here's a breakdown of the acceptance criteria and the supporting study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes the device's accuracy for various parameters and states that it was found to be "safe and effective" and "substantially equivalent" to a predicate device.

Table 1: Reported Device Performance (Derived from stated validation results)

Study Information

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

• Left Ventricular Functional Parameters:
  • In-house trial: 217 patients
  • Multicenter trial: 80 patients
• Computer Assisted Visual Scoring: 20 patients
• Prognostic Information: 504 patients
• Expert System Image Interpretation: 461 patients
• Patient Specific 3D Coronary Overlay: 9 patients

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. The reference to "multicenter trial" suggests data from multiple sites, but further geographical details are absent.

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

The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set. It mentions "user verification of output is required" and that the "physician should integrate all of the patients' clinical and diagnostic information" for final interpretation, implying human expert involvement in the overall diagnostic process.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth within the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is explicitly mentioned. The document focuses on the algorithm's performance and its role as an aid to the physician, rather than comparing human reader performance with and without AI assistance to determine an effect size.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance evaluation of the algorithms was implicitly done for the various features. The "multicenter trial results listed in the article by Vansant et al" are referenced for the "expected accuracy of the program," suggesting evaluation of the algorithm's output. The statement "the program processes the studies automatically, however, user verification of output is required and manual processing capability is provided" also supports the idea of an underlying standalone algorithmic processing.

7. The Type of Ground Truth Used:

The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for "Left Ventricular Functional Parameters," the implication is that the ground truth would be based on established methods for measuring cardiac function, likely involving a combination of clinical assessment and/or other imaging modalities. For "Prognostic Information," the ground truth would typically be patient outcome data over time. For "Computer Assisted Visual Scoring" and "Expert System Image Interpretation," the ground truth would likely involve expert interpretation.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established:

The document does not explicitly describe how the ground truth for the training set was established.

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The Emory Cardiac Tool Box™ (CEqual®,EGS™) software program should be used for the quantification of perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated TC99m SPECT myocardial perfusion studies (EGSTM).

The Emory Cardiac Tool Box™ (CEqual®, EGS™) is used to display gated wall motion and for quantifying parameters of left-ventricular from gated SPECT myocardial perfusion studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass and transient ischemic dilatation (TID). This program was developed to run in the IDL operating system environment and can be executed on any nuclear medicine computer systems which supports IDL. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

Here's a breakdown of the acceptance criteria and the study details for the "Emory Cardiac Tool Box" device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the device's functionality and its intended use but does not explicitly state numerical acceptance criteria for its performance. Instead, it refers to the "expected accuracy of the program" being found in a multicenter trial. The "reported device performance" is thus interpreted as the success in demonstrating equivalence to a predicate device through these studies.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

The document refers to two main types of studies: in-house trial validations and a multicenter trial validation.

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

• In-house trial validations: 217 patients
  • Provenance: Not explicitly stated, but "in-house" suggests data likely from Emory University or affiliated institutions. The temporal nature (retrospective/prospective) is not specified.
• Multicenter trial validation: 80 patients
  • Provenance: "Multicenter trial" implies data from multiple institutions, but specific countries of origin are not mentioned. The temporal nature (retrospective/prospective) is not specified.

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

The document does not specify the number of experts used to establish ground truth or their qualifications for either the in-house or multicenter trials. It mentions that the physician should integrate all clinical and diagnostic information for a final interpretation, but this is about clinical use, not the ground truth establishment for the validation studies.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to measure the effect size of how much human readers improve with AI vs. without AI assistance. The device is described as a "display and processing program to aid in the diagnostic interpretation," not as an AI-assisted diagnostic tool in the sense of directly impacting reader performance metrics. It's a quantitative tool for the physician.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device performs "automatically" and provides quantitative parameters such as ejection fraction and ventricular volumes. Therefore, standalone algorithm-only performance is implied in the calculation of these parameters. However, the document also states, "user verification of output is required and manual processing capability is provided," indicating that it's designed for use with a human in the loop for final interpretation. The validation studies focused on the accuracy of these automatically generated parameters.

7. The Type of Ground Truth Used

The document does not explicitly state the method used to establish ground truth (e.g., expert consensus, pathology, outcomes data). For parameters like ejection fraction and ventricular volumes in nuclear medicine, ground truth is often established through:

• Correlation with other imaging modalities (e.g., echocardiography, cardiac MRI - though less common in 1998 for routine validation)
• Expert interpretation with manual or semi-automated analysis of raw images (potentially considered "expert consensus" in a practical sense).
• It is highly unlikely pathology or outcomes data would be used directly for these specific functional parameters.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "various stages of software development which included the initial design, coding, debugging, testing, and validation" and "phantom and computer simulations studies," which would likely involve data for development and internal testing/training, but specific numbers are not provided.

9. 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. Given the device's function (quantification of ventricular parameters), it's highly probable that training data ground truth would have been derived from independently validated measurements, potentially from other imaging modalities or highly experienced manual analysis, but this is not confirmed in the text.

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