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This software program should be used to quantitatively analyze the myocardial perfusion of patients' who have been injected with Cardiolite® (Technetium Tc99m Sestamibi) for a rest/stress same-day Single Photon Emission Computerized Tomography (SPECT) acquisition protocol. Cardiolite®, Kit for the Preparation of Technetium Tc99m Sestamibi is a myocardial perfusion agent that is useful in the evaluation of ischemic heart disease. Technetium Tc99m Sestamibi is useful in distinguishing normal from abnormal myocardium and in the localization of the abnormality, in patients with suspected myocardial infarction, ischemic heart disease or coronary artery disease. Evaluation of ischemic heart disease or coronary artery disease is accomplished using rest and stress techniques.

Preparation of Technetium Tc99m Sestamibi is also useful in the evaluation of myocardial function using the first pass technique.

Rest-exercise imaging with Tc99m Sestamibi in conjunction with other diagnostic information may be used to evaluate ischemic heart disease and its localization.

In clinical trials, using a template consisting of the anterior wall, inferior-posterior wall and isolated apex, localization in the anterior or inferior-posterior wall in patients with suspected angina pectoris or coronary artery disease was shown. Disease localization isolated to the apex has not been established. Tc99m Sestamibi has not been studied or evaluated in other cardiac diseases.

It is usually not possible to differentiate recent from old myocardial infarction or to differentiate recent myocardial infarction from ischemia.

This medical device (CEqual®) is a diagnostic software program that quantitatively analyzes the myocardial perfusion of patients' injected with Cardiolite® (99mTc Sestamibi) following a rest/stress same-day SPECT acquisition protocol. The algorithm automatically determines the processing parameters and, following operator verification of these parameters, samples the myocardium using maximum count profiles. These stress and rest profiles are then used to generate relative count "raw data" polar maps. In addition, the profiles are compared to a normal data base and the results of this comparison are used to generate quantitative stress and rest polar maps which indicate defect extent, severity, and reversibility for all abnormal perfusion areas of the patients' study. The final results are presented in the form of polar maps as well as a table indicating the % abnormal pixels in territories supplied by the left anterior descending, left circumflex, and right coronary arteries.

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

Acceptance Criteria and Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%). Instead, it refers to the program's accuracy being "similar to those obtained with previous quantitative analysis programs." It describes the intended function of the device and its role as an adjunctive diagnostic tool.

However, based on the "Effectiveness" section, we can infer a general acceptance criterion related to its performance being comparable to established methods.

Study Details

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

   • Test Set Sample Size: 35 patients.
   • Data Provenance: The data was "acquired and processed at another institution," indicating an external, prospective collection. The country of origin is not specified, but the references are primarily from US-based journals and institutions, suggesting US origin.
   • Retrospective or Prospective: Prospective validation.

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

   • This information is not provided in the document. The text states "The effectiveness of the program has been established in a prospective validation which included 35 patients," but does not detail how ground truth for these 35 patients was established. The references listed (especially the multi-center trials for Tl-201 and Technetium-99m sestamibi) likely used expert interpretation, but this is not explicitly linked to the ground truth of this specific 35-patient validation study.

3. Adjudication method for the test set:

   • This information is not provided in the document.

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:

   • A formal MRMC comparative effectiveness study was not described for this specific device's validation. The text clarifies, "It was not meant to replace or eliminate the standard visual analysis of the Cardiolite® images," indicating it's an adjunctive tool. The study focuses on the standalone performance of the algorithm itself in comparison to established methods, not on human reader improvement with AI assistance.

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

   • Yes, a standalone validation was done. The described "prospective validation which included 35 patients" assesses the "accuracy results obtained with this program," implying the algorithm's direct output was evaluated. The comparison is made to the accuracy of previous quantitative analysis programs, which are also standalone algorithms.

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

   • This information is not explicitly stated for the 35-patient validation study. Given the nature of myocardial perfusion studies, the ground truth for diagnosing ischemic heart disease or coronary artery disease in the broader context often involves a combination of clinical assessment, invasive angiography (coronary artery disease status), follow-up for cardiac events (outcomes data), or expert interpretation of the gold standard imaging itself (though this creates a circularly dependent ground truth). The references (especially Van Train et al., 1993, 1994) imply "definition and validation of stress normal limits and criteria for abnormality," which would likely involve expert consensus and correlation with other diagnostic findings, but this isn't clarified for the 35 patients.

7. The sample size for the training set:

   • The document does not provide a specific sample size for the training set. It refers to the program using a "normal data base" for comparison, which would be derived from a training or reference set, but its size is not mentioned. The references, particularly Van Train et al., 1993, describe building "normal limits," which would involve a cohort of healthy individuals.

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

   • This is not explicitly detailed for a "training set" in the context of this document. However, the mention of comparing to "a normal data base" implies that this database was established with a ground truth representing normal myocardial perfusion. Based on the references, it's highly probable this involved:
     • Expert Consensus/Clinical Criteria: Normal limits are typically established using a cohort of individuals with a low likelihood of coronary artery disease, confirmed by clinical assessment, normal ECG, and possibly other tests.
     • Angiography (Absence of Disease): For "normal limits" in the context of perfusion, individuals often undergo coronary angiography to confirm the absence of significant coronary artery disease.
     • Follow-up Outcomes: Long-term follow-up confirming the absence of cardiac events can also define a "normal" population.
   • Reference 3 specifically mentions "definition and validation of stress normal limits and criteria for abnormality," which is a key process for establishing the ground truth for such a normal database.

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