(85 days)
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:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (SPECTEF Protocol, K954874) | Demonstrated through various stages of software development (design, coding, debugging, testing, validation), phantom and computer simulations, in-house trial validations, and a multicenter trial validation. The FDA concluded substantial equivalence. |
| Quantification of Left-Ventricular Parameters: | Parameters quantified by the device: Ejection Fraction, End-Diastolic Volume, End-Systolic Volume, Myocardial Mass, Transient Ischemic Dilatation (TID). |
| Accuracy of Ventricular Parameter Calculation: | Evaluated in an in-house trial of 217 patients and a multicenter trial of 80 patients. (Specific accuracy metrics are not provided in this document). |
| Display of Gated Wall Motion: | Device successfully displays gated wall motion. |
| User Verification and Manual Processing Capability | Provided for user verification of output and manual processing. |
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.
§ 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.