(20 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 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 userdocumented images, cited literature and additional relevant information.
The post-processing application syngo.CT CaScoring SOMARIS/8 VB70 is 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 lessions 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.
Here's a breakdown of the acceptance criteria and study information for the syngo.CT CaScoring device, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All pre-specified acceptability criteria were passed" for the performance evaluation of the algorithm, particularly for the Agatston-equivalent score and its classification into categories. However, the specific numerical targets for these criteria are not explicitly detailed in the provided text. The performance is described qualitatively as "adequate and acceptable."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Total Agatston-equivalent score | Adequate and acceptable performance (all pre-specified acceptability criteria passed) |
| Classification into Agatston score categories | Adequate and acceptable performance (all pre-specified acceptability criteria passed) |
| Algorithm execution on testing datasets | Successfully executed on all testing datasets |
| Software specifications | All met the acceptance criteria |
| Risk control | Implemented to mitigate identified hazards |
| Functional and Integration Tests | Device performs as intended |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that the algorithm was "re-trained on a larger database" and a "complete performance evaluation (bench test) of the algorithm has been conducted additionally" using "all testing datasets."
- Test Set Sample Size: Not explicitly stated as a number of cases or images. It refers to "all testing datasets," implying all available data used for the bench test.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only mentions "re-annotated data" as the basis for retraining.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed. The document focuses on the automated algorithm's performance (standalone bench test) without human-in-the-loop comparison.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The document states:
- "The algorithm was successfully executed on all testing datasets."
- "A complete performance evaluation (bench test) of the algorithm has been conducted additionally."
- "The summary of the bench test is that an adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories..."
7. Type of Ground Truth Used
The ground truth for the testing set was based on "re-annotated data." The specific nature of this re-annotation (e.g., whether it involved expert consensus, pathology, or other methods) is not explicitly detailed.
8. Sample Size for the Training Set
The document mentions that "the algorithm was retrained on a larger database." The specific sample size (number of cases or images) for this training set is not explicitly stated.
9. How the Ground Truth for the Training Set Was Established
The training set ground truth was established through "re-annotated data." The exact method or source of this re-annotation (e.g., expert review, a specific validated method) is not explicitly detailed.
§ 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.