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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."

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.

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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 user-documented images, cited literature and additional relevant information.

The post-processing application syngo.CT CaScoring SOMARIS/8 VB50 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.

For the current software version SOMARIS/8 VB50 one major and one minor change have been implemented:

• . Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB40, K192763, clearance date 12/17/2019) the algorithm to precompute the calcium score has been enhanced and extended. In the subject device, the CaScoring algorithm was extended to label coronary calcifications as belonging to either the left main, left anterior descending, left circumflex or right coronary artery.
• . This version contains UI (user-interface) modifications.

The provided text outlines the performance evaluation of the syngo.CT CaScoring algorithm. Although it mentions a "bench test" and a "reader study," the details regarding the acceptance criteria and the studies are somewhat general. Based on the information available, here's a structured description:

Acceptance Criteria and Device Performance Study

The syngo.CT CaScoring device aims to automatically score and assign coronary calcifications to specific coronary arteries. The enhanced algorithm's performance was evaluated through a "bench test" and a "reader study."

1. Table of Acceptance Criteria and Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Bench Test: Not explicitly stated, but described as "considerably more diverse" than the reader study population, implying a larger and/or more varied dataset.
  • Reader Study: Not explicitly stated, but mentioned to be "from a single, modern scanner."
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. However, for a bench test and reader study evaluating an enhanced algorithm, it is common to use retrospective data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: The reader study involved "three individual readers."
• Qualifications of Experts: Not explicitly stated within the provided text. It is generally assumed that "readers" in a medical imaging context are qualified medical professionals like radiologists or cardiologists.

4. Adjudication Method for the Test Set

• The reader study mentions comparing the performance of "the three individual readers compared to their consensus." This strongly implies a consensus-based adjudication method for establishing the ground truth. A common consensus method is a (N-1) rule or a majority vote among multiple experts (e.g., 2 out of 3, 3 out of 4). The text doesn't specify the exact method (e.g., 2+1 or 3+1), but the use of "their consensus" indicates that the three readers arrived at an agreed-upon ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, a multi-reader multi-case (MRMC) study was implicitly part of the "reader study." The study involved "three individual readers" and compared their performance (as part of a consensus group) against the algorithm.
• Effect Size: The text states: "No statistically relevant difference between the performance of the three individual readers compared to their consensus, and the algorithm compared to the consensus was found." This suggests that the AI assistance (or the algorithm's standalone performance compared to human consensus) did not statistically significantly improve or worsen the performance for the specific metrics evaluated, particularly for vessel-specific assignments where the task was similarly difficult for humans and the algorithm. It does not provide a specific quantitative effect size (e.g., AUC increase, accuracy percentage point change) for human reader improvement with versus without AI assistance. The focus seems to be on whether the algorithm performs comparably to expert consensus.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was done. The "bench test" assessed the "adequate and acceptable performance of the automatic scoring algorithm" independently. The "reader study" also compared the algorithm's performance directly against the human consensus, indicating an assessment of its standalone capabilities.

7. Type of Ground Truth Used

• The ground truth for the test sets (both bench test and reader study) was established by expert consensus annotations. The text explicitly mentions "consensus annotations" for comparing automatically assigned LM scores and for comparing reader performance.

8. Sample Size for the Training Set

• The sample size for the training set is not specified in the provided text. It only mentions that the "automatic scoring algorithm was retrained on re-annotated data as part of the vessel assignment extension."

9. How Ground Truth for Training Set was Established

• The ground truth for the training set was established through re-annotation. The text states, "the automatic scoring algorithm was retrained on re-annotated data." While the specifics of who performed the re-annotation (e.g., experts, number of experts, adjudication) are not detailed, it implies data that underwent a human review and labeling process to serve as the training truth.

Ask a specific question about this device

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.

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.

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