(77 days)
The Emory Cardiac Tool Box™ (CEqual®, EGS™) 2.1 software program should be used for the quantification of left-ventricular function parameters and for the display of wall motion and quantification of the results of the SPECT & PET myocardial perfusion studies (EGS™).
The Emory Cardiac Tool Box™ 2.1 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies. 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 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 environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
The provided text offers details about the Emory Cardiac Tool Box™ 2.1, but it does not explicitly state specific acceptance criteria or present a detailed study comparing device performance against such criteria in a table format. It primarily focuses on demonstrating substantial equivalence to its prior version.
However, based on the information provided, we can infer some aspects related to its validation and the types of studies performed.
Here's a breakdown of the available information structured to answer your questions, with inferences made where direct statements are lacking:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria. It mentions "expected accuracy" for the prior version (Vansant et al.) and states that accuracy for version 2.1 can be found in "Item F (Testing & Validation)" of the 510(k) submission, which is not fully included here.
Instead, the document focuses on validation studies for different features, implying that the successful completion of these studies demonstrated the device's effectiveness.
| Feature/Parameter Tested | Performance/Validation Result | Indirect Acceptance Implication |
|---|---|---|
| Left Ventricular Functional Parameter Calculations | Evaluated in 217 patients | Successful calculation of parameters in a significant patient cohort. |
| Multicenter Trial Validation (overall device function) | 80 patients | Demonstrated effectiveness in a broader clinical setting. |
| Computer Assisted Visual Scoring | Successfully evaluated in 20 patients | Ability to assist in visual scoring. |
| Prognostic Information | Successfully evaluated in 504 patients | Capability to provide prognostic data. |
| Expert System Image Interpretation | Successfully evaluated in 461 patients | Functionality of the expert system for image interpretation. |
| Patient Specific 3D Coronary Overlay | Successfully evaluated in 9 patients | Effectiveness of the 3D overlay feature. |
| Rb-82 Normal Limits Development & Validation | 176 patients | Development and validation of normal limits for specific imaging agent. |
| PET Tools for Perfusion-Metabolism Match-Mismatch | 90 patients | Validation of PET tools for specific assessments. |
| Safety | Determined through software development stages (design, coding, debugging, testing, validation) | Implies software robustness and reliability. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several validation activities rather than a single unified "test set."
- Left ventricular functional parameters: 217 patients (retrospective/prospective not specified, country not specified).
- Multicenter trial: 80 patients (retrospective/prospective not specified, country not specified).
- Computer assisted visual scoring: 20 patients (retrospective/prospective not specified, country not specified).
- Prognostic information: 504 patients (retrospective/prospective not specified, country not specified).
- Expert system image interpretation: 461 patients (retrospective/prospective not specified, country not specified).
- Coronary fusion algorithms (3D overlay): 9 patients (retrospective/prospective not specified, country not specified).
- Rb-82 normal limits: 176 patients (retrospective/prospective not specified, country not specified).
- PET tools for perfusion-metabolism match-mismatch: 90 patients (retrospective/prospective not specified, country not specified).
The data provenance (country of origin, retrospective/prospective) is not explicitly stated for any of these patient cohorts.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the validation cohorts. It mentions "physician will utilize for his final interpretation" and "standard visual analysis," implying qualitative assessment by medical professionals, but details are absent.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets mentioned in the validation studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not explicitly described in the provided text. The document states the program "serves merely as a display and processing program to aid in the diagnostic interpretation" and is "not meant to replace... visual analysis," suggesting an assistive role. However, no study measuring the improvement of human readers with AI assistance is detailed.
6. Standalone (Algorithm Only) Performance
The document does not explicitly describe a standalone performance study where the algorithm's performance is tested without human-in-the-loop. The statement "user verification of output is required" and "manual processing capability is provided" reinforces the idea of human oversight, rather than a purely standalone AI performance. The various "successful evaluations" of parameters and algorithms imply some form of standalone capability for those specific functions, but a comprehensive standalone performance study is not presented.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the various validation studies. However, given the context of myocardial perfusion studies and functional parameters, it's highly probable that ground truth would have been established through a combination of:
- Expert consensus: For visual scoring, interpretation, and potentially defining "normal limits."
- Clinical outcomes data: Potentially for prognostic information algorithms.
- Corroboration with other diagnostic modalities: Although not explicitly stated, this is common in cardiology.
- Known "truth" from phantom/computer simulations: Mentioned as part of the overall effectiveness determination, suggesting a controlled environment for some initial testing.
8. Sample Size for the Training Set
The document does not explicitly state the sample size used for the training set. The patient numbers provided are for "evaluations," "validations," or "trials," which typically refer to test or validation sets rather than pure training sets.
9. How the Ground Truth for the Training Set Was Established
Since a training set size or methodology is not explicitly mentioned, the method for establishing ground truth for a training set is not described 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.