(78 days)
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.
The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).
syngo. CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.
syngo.CT CaScoring is a post processing application designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.
A listing of device modifications as part of the new software version SOMARIS/8 VB40 of syngo.CT CaScoring is as follows:
- Updated Indications for Use Statement .
- Support of the CaScoring algorithm to precompute the calcium score ●
- Support of Rapid Results Technology for the CaScoring algorithm ●
The Siemens syngo.CT CaScoring device is an image analysis software package for evaluating CT data sets to identify and quantify calcified coronary lesions.
Here's an breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document indicates that the acceptance criteria for the automated calcium scoring evaluation involved demonstrating "adequate overall accuracy of the prediction of the calcium risk category." However, specific numerical thresholds for "adequate accuracy" are not explicitly stated in the provided text. The reported performance is that the algorithm was "successfully executed on all test data" and an "adequate overall accuracy" was found.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate adequate overall accuracy of the prediction of the calcium risk category for the automated calcium scoring evaluation. | Algorithm successfully executed on all test data. Adequate overall accuracy of calcium risk category prediction found. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the automated calcium scoring evaluation was validated using a "bench test" and that the algorithm was implemented on "all test data." While it states that the algorithm was "successfully executed on all test data," it does not specify the sample size of the test set nor its data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to any effect size of human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done for the automated calcium scoring evaluation. The document states: "For the new feature automated calcium scoring evaluation, a bench test has been conducted to show it performs as intended. The algorithm was successfully executed on all test data. An adequate overall accuracy of the prediction of the calcium risk category was found." This indicates that the algorithm's performance was evaluated by itself.
7. Type of Ground Truth Used
The document implies that the ground truth for the automated calcium scoring evaluation test set was based on a "prediction of the calcium risk category." However, the method by which this ground truth was established (e.g., expert consensus, pathology, outcomes data) is not explicitly stated. Given that the device interactively marks calcified lesions and calculates scores, it is likely based on expert annotations or a reference standard derived from medical imaging.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.