(77 days)
The Emory Cardiac Toolbox™ (CEqual®, EGS™) 2.0 software program should be used for the quantification of myocardial perfusion (CEqual®) and for the display of wall motion and quantification of left-ventricular function parameters from gated Tc99m SPECT myocardial perfusion studies (EGS™).
The Emory Cardiac Tool Box™ 2.0 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). 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 . The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
The provided document details the 510(k) summary for the Emory Cardiac Tool Box™ 2.0. Here's a breakdown of the acceptance criteria and the supporting study information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes the device's accuracy for various parameters and states that it was found to be "safe and effective" and "substantially equivalent" to a predicate device.
Table 1: Reported Device Performance (Derived from stated validation results)
| Feature/Parameter | Reported Device Performance / Validation |
|---|---|
| Left Ventricular Functional Parameters | Evaluated in 217 patients (in-house trial) and 80 patients (multicenter trial). |
| Computer Assisted Visual Scoring | Successfully evaluated in 20 patients. |
| Prognostic Information | Successfully evaluated in 504 patients. |
| Expert System Image Interpretation | Successfully evaluated in 461 patients. |
| Patient Specific 3D Coronary Overlay | Successfully evaluated in 9 patients. |
| Phantom and Computer Simulations | Used for safety and effectiveness establishment. |
| Substantial Equivalence | Demonstrated with Emory Cardiac Tool Box™ (CEqual®, EGS™) Version 1.0 (K980914). |
Study Information
2. Sample Sizes Used for the Test Set and Data Provenance:
- Left Ventricular Functional Parameters:
- In-house trial: 217 patients
- Multicenter trial: 80 patients
- Computer Assisted Visual Scoring: 20 patients
- Prognostic Information: 504 patients
- Expert System Image Interpretation: 461 patients
- Patient Specific 3D Coronary Overlay: 9 patients
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. The reference to "multicenter trial" suggests data from multiple sites, but further geographical details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set. It mentions "user verification of output is required" and that the "physician should integrate all of the patients' clinical and diagnostic information" for final interpretation, implying human expert involvement in the overall diagnostic process.
4. Adjudication Method for the Test Set:
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth within the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is explicitly mentioned. The document focuses on the algorithm's performance and its role as an aid to the physician, rather than comparing human reader performance with and without AI assistance to determine an effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation of the algorithms was implicitly done for the various features. The "multicenter trial results listed in the article by Vansant et al" are referenced for the "expected accuracy of the program," suggesting evaluation of the algorithm's output. The statement "the program processes the studies automatically, however, user verification of output is required and manual processing capability is provided" also supports the idea of an underlying standalone algorithmic processing.
7. The Type of Ground Truth Used:
The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for "Left Ventricular Functional Parameters," the implication is that the ground truth would be based on established methods for measuring cardiac function, likely involving a combination of clinical assessment and/or other imaging modalities. For "Prognostic Information," the ground truth would typically be patient outcome data over time. For "Computer Assisted Visual Scoring" and "Expert System Image Interpretation," the ground truth would likely involve expert interpretation.
8. The Sample Size for the Training Set:
The document does not explicitly state the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established:
The document does not explicitly describe how the ground truth for the training set was established.
§ 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.