(67 days)
This software program should be used to guantitatively 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. Cardiolite®, Kit for the Preparation of 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 Evaluation of ischemic heart disease or coronary artery disease. coronary artery disease is accomplished using rest and stress techniques.
Cardiolite®, Kit for the 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.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). Tomographic imaging (SPECT) for non Positron emitter.
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.
The provided text describes the CEqual® software, a diagnostic program that quantitatively analyzes myocardial perfusion from SPECT acquisitions using Cardiolite® (Technetium Tc99m Sestamibi). The software generates polar maps indicating defect extent, severity, and reversibility, and a table showing the percentage of abnormal pixels in territories supplied by major coronary arteries.
Here is an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with specific threshold values for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that "The accuracy results obtained with this program are similar to those obtained with previous quantitative analysis programs of the TI-201 myocardial perfusion agent (1,2) and Cardiolite® (3,4)." This implies that the acceptance criterion was likely non-inferiority or comparable performance to existing, legally marketed predicate devices rather than meeting a specific numerical target.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Comparable to established quantitative analysis programs for Tl-201 and Cardiolite® myocardial perfusion agents. | "The accuracy results obtained with this program are similar to those obtained with previous quantitative analysis programs of the TI-201 myocardial perfusion agent (1,2) and Cardiolite® (3,4)." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 35 patients.
- Data Provenance: The study was a "prospective validation which included 35 patients acquired and processed at another institution." This indicates the data was prospective and collected from an institution different from the developers. The country of origin is not specified, but the references suggest it was likely within the United States, given the authors and journals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth for the test set.
4. Adjudication Method for the Test Set
The adjudication method for the test set is not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as part of this device's validation. The focus was on the software's performance itself rather than human reader improvement with AI assistance. The text mentions the program is an "adjunctive diagnostic tool" and not meant to replace visual analysis, suggesting it's for human-in-the-loop use but doesn't quantify reader improvement.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The description "The effectiveness of the program has been established in a prospective validation which included 35 patients acquired and processed at another institution" refers to the algorithm's performance as a standalone tool, comparing its quantitative results against some form of ground truth (or established accuracy benchmarks of predicate devices as per the acceptance criteria).
7. The Type of Ground Truth Used
The specific type of ground truth used to evaluate the 35 patients in the prospective validation is not explicitly stated. However, given the context of myocardial perfusion imaging for "evaluation of ischemic heart disease or coronary artery disease" and localization of abnormalities, common ground truth types in such studies include:
- Expert Consensus: Visual interpretation by experienced cardiologists or nuclear medicine physicians.
- Coronary Angiography: An invasive procedure considered the gold standard for anatomical assessment of coronary artery disease.
- Clinical Outcomes: Follow-up data on patient events (e.g., myocardial infarction, revascularization).
The reference to "previous quantitative analysis programs" suggests the ground truth was comparable to what was used in those studies, which often involves a combination of expert visual assessment and, for more definitive studies, angiography.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It mentions "a normal data base" used to generate quantitative stress and rest polar maps, implying a training or reference set was used, but the size is not provided.
9. How the Ground Truth for the Training Set Was Established
The document states that the software compares patient profiles "to a normal data base." This "normal data base" serves as a reference for quantifying abnormalities. How the ground truth for this normal data base was established is not explicitly detailed. It can be inferred that this database would consist of studies from individuals confirmed to have normal myocardial perfusion, likely established through:
- Absence of clinical symptoms of cardiac disease.
- Normal findings on other diagnostic tests (e.g., EKG, echocardiogram).
- Possibly, follow-up to ensure no cardiac events.
- Expert interpretation confirming normalcy.
The references provided (1, 2, 3, 4) might contain more details about the methodology for creating such "normal databases" in studies of similar quantitative myocardial perfusion agents. For example, Van Train et al. (1993, Ref 3) specifically mentions "definition and validation of stress normal limits," which would involve establishing the ground truth for a normal cohort.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.