(8 days)
The Emory Cardiac Toolbox™ (CEqual®, EGS™) 2.6 software program should be used for the quantification of myocardial perfusion (CEqual®), for the display of wall motion for the quantification of left-ventricular function parameters from gated Tc99m gPECT & and quantification of lell-venthcaller fanonen for the 3D alignment of coronary artery PET myocarulal perfusion studies (LES - ); and ter the left ventricular 3D epicardial surface.
The Emory Cardiac Toolbox™ 2.6 is used to display gated wall motion and for quantifying The Emory Strends Tronular perfusion and function from gated SPECT & PET myocardial paramours of ices. These parameters are: perfusion, 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 the program of or are riog, prognostic information, expert system image interpretation, and patient specific 3D coronary overlay. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D of coronaly aftery models from of corenary any in the IDL operating systems which epicalular sunace. "This program was avversions on any nuclear medicine computer systems to The supports IDL and the Aladdin (General Electric) software development environment. The Supports IDL and the Riadain (Gonoral Elookie) Sownload of output is required and manual processing capability is provided.
Here's a breakdown of the acceptance criteria and study information for the Emory Cardiac Toolbox™ 2.6, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it describes a series of validation studies with their corresponding patient numbers. The "device performance" in this context refers to the successful evaluation and validation of various algorithms, implying they met the implicit criteria for functionality and accuracy.
| Feature/Parameter Tested | Number of Patients/Cases | Study Type/Purpose | Reported Performance (Implicit Acceptance) |
|---|---|---|---|
| Left ventricular functional parameter calculations | 217 (initial program, in-house) & 80 (multicenter) | Phantom & Multicenter Trial Validation (Accuracy) | Successfully evaluated and validated. |
| Computer assisted visual scoring | 20 (patients) | Validation | Successfully evaluated. |
| Prognosis program | 504 (patients) | Validation | Successfully evaluated. |
| Expert system | 461 (patients) | Validation | Successfully evaluated. |
| Coronary fusion algorithms | 9 (patients) | Validation | Successfully evaluated. |
| Normal limits (Emory Cardiac Toolbox™ 2.1) | 176 (patients) | Validation | Successfully completed. |
| PET tools for assessment of perfusion – metabolism match-mismatch | 90 (patients) | Validation | Successfully completed. |
| N-13-ammonia normal limits | 144 (patients) | Validation | Successfully completed. |
| Alignment of 3D models of coronary arteries onto the left ventricular 3D epicardial surface | Not explicitly given specific patient count for this specific validation, but "successfully completed" | Validation | Successfully completed. |
2. Sample Sizes and Data Provenance
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Test Set Sample Sizes:
- Left ventricular functional parameter calculations: 217 (in-house) and 80 (multicenter).
- Computer assisted visual scoring: 20 patients.
- Prognosis program: 504 patients.
- Expert system: 461 patients.
- Coronary fusion algorithms: 9 patients.
- Normal limits (Emory Cardiac Toolbox™ 2.1): 176 patients.
- PET tools for perfusion-metabolism: 90 patients.
- N-13-ammonia normal limits: 144 patients.
- Alignment of 3D models of coronary arteries: Not explicitly stated as a separate patient cohort, but implied to be validated with existing data or a subset.
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Data Provenance: The document mentions "in-house" validation and a "multicenter trial validation," indicating that data was gathered from more than one institution. Specific countries of origin are not detailed, nor is it explicitly stated whether the data was retrospective or prospective, though multicenter trials are often prospective or a mix.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications. It mentions "computer assisted visual scoring," implying human visual interpretation, but the details of the ground truth establishment for the various functional parameter calculations and algorithms are not provided.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth on the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study that quantitatively assesses how much human readers improve with AI vs. without AI assistance is not described in the provided text. The document refers to the program as "merely a display and alignment and processing program to aid in the standard visual analysis" and states it is "not meant to replace or eliminate the recall of the patients' clinical and diagnostic information." This suggests the device is considered an aid rather than a replacement, but specific efficacy over human-only reading is not quantified.
6. Standalone (Algorithm Only) Performance Study
Yes, standalone (algorithm only) performance was done. The description of the validation studies for "left ventricular functional parameter calculations," "computer assisted visual scoring," "prognosis program," "expert system," "coronary fusion algorithms," "normal limits," "PET tools," and "N-13-ammonia normal limits" indicates that the algorithms within the Toolbox were evaluated for their accuracy and functionality. The general wording of "successfully evaluated" for these specific functions implies their standalone performance was assessed.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly detailed for each study. However, given the context of myocardial perfusion, ejection fraction, ventricular volumes, and coronary artery models, it's highly probable that a combination of:
- Expert Consensus: For visual scoring, qualitative interpretation, and possibly for establishing "normal limits."
- Reference Standards/Clinical Data: For validating quantitative measurements (e.g., ejection fraction, volumes) against established methods or clinical outcomes, although this is not explicitly stated as "outcomes data."
- Pathology: Not directly mentioned, but could be a component for certain diagnoses.
The statement that the program itself is "not perfect, and will be accompanied with some false positive and false negative results" suggests that there was a ground truth against which these "false positives and negatives" were defined.
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set of the algorithms. The numbers provided (217, 80, 20, 504, 461, 9, 176, 90, 144 patients) relate to validation studies. For a device cleared in 2004, common practice at the time often involved using the same data sets (or subsets thereof) for both development/training and validation, or it might not have been standard to strictly delineate "training" and "test" sets in the same way as modern machine learning development.
9. How Ground Truth for the Training Set Was Established
Since an explicit training set size isn't provided, the method for establishing its ground truth is also not detailed. However, it's reasonable to infer that if a training set were used, its ground truth would have been established through methodologies similar to those used for validation sets (e.g., expert consensus, reference standards, and clinical data), but these details are not present in the provided 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.