(90 days)
From user specified sets of CT cardiac images, Calcium Scoring can be used to: -
- Allow the user to interactively indicate regions of detected calcification .
- To allow the user to allocate each detected region to one of several coronary arteries .
- To estimate algorithmically a score for the amount of detected calcification in each allocated . artery
- To prepare reports including calcium score data, imagery, ECG traces, Comparison of score ◆ to cited literature and additional relevant information
The calcium-scoring package is a diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, which is a risk factor for coronary artery disease. Calcium sconing may be used to monitor the progression or regression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack.
Calcium Scoring is a software package running on the 3Dvirtuoso workstation that allows the user to mark regions of detected calcification in CT cardiac images, to assign each region to a coronary artery, and to calculate the Agatston score and other information from the identified pixels. Film and paper reports of the results can also be prepared. Calcium Scoring is also a cost-effective alternative to Electron Beam CT (EBCT), since it produces calcium scores that correlates to the EBCT's gold standard, but at a much lower cost.
The provided text is a 510(k) summary for the Siemens Calcium Scoring Software Package (K990426). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria and a comprehensive study description. Therefore, some of the requested information, particularly regarding specific acceptance criteria, detailed study design, and sample sizes for testing and training, is not explicitly stated in the provided text.
Based on the available information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or agreement thresholds. Instead, it describes the software's functionality and implies its performance by stating its ability to "calculate the Agatston score and other information from the identified pixels" and that it "produces calcium scores that correlates to the EBCT's gold standard." The primary "performance" mentioned is its correlation to a gold standard and its function as a cost-effective alternative.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to mark regions of calcification in CT cardiac images | Allows the user to interactively indicate regions of detected calcification. |
| Ability to assign calcifications to coronary arteries | Allows the user to allocate each detected region to one of several coronary arteries. |
| Ability to calculate Agatston score and related information | Algorithmically estimates a score for the amount of detected calcification in each allocated artery; calculates the Agatston score and other information from identified pixels. |
| Correlation of calculated calcium scores to EBCT gold standard | Produces calcium scores that correlates to the EBCT's gold standard. |
| Ability to generate reports | Prepares reports including calcium score data, imagery, ECG traces, comparison of score to cited literature, and additional relevant information. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions a correlation to "EBCT's gold standard" but doesn't elaborate on the study that established this correlation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The reference to "EBCT's gold standard" implies that Electron Beam CT was used as a reference, but it doesn't detail how this "gold standard" data was analyzed or confirmed by experts for the purpose of validating the software.
4. Adjudication method for the test set
The document does not specify any adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the software's functionality and its equivalence to predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The software is described as allowing the user to "interactively indicate regions of detected calcification" and "allocate each detected region." This implies a human-in-the-loop approach. While it then "estimates algorithmically a score," the initial steps involve user interaction. Therefore, a standalone (algorithm only) performance assessment as a primary validation step is not explicitly described or indicated by the software's interactive nature as presented.
7. The type of ground truth used
The primary ground truth referenced is "EBCT's gold standard." This implies that electron beam computed tomography results were considered the highly accurate reference for calcium scoring, against which the software's output was correlated.
8. The sample size for the training set
The document does not specify the sample size for a training set. Given the era (1999) and the nature of the submission (510(k) for substantial equivalence), detailed information on deep learning training sets is unlikely to be present.
9. How the ground truth for the training set was established
The document does not specify how ground truth for a training set was established, nor does it explicitly mention a distinct training set.
§ 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.