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Cardiac Function Analysis: The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

Calcium Scoring: The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Cardiac Function Analysis and Calcium Scoring are add-on software packages designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by these two new devices are:

Cardiac Function Analysis software post-processes ECG-gated cardiac CT images and extracts the following left ventricular parameters from multi-phase data.

• Left ventricular ejection fraction
• End diastolic volume
• End systolic volume
• Stroke volume
• Cardiac output
• Cardiac Index
• Wall thickness
• Wall thickness ratio
• Wall movement .
• . Volume Curve

Calcium Scoring software post-processes DICOM-based cardiac CT images and evaluates calcified plaque in the coronary arteries, providing the clinician with both Agatston and Volume calcium scores. These regions of interest are selected by the user.

The provided text does not contain detailed acceptance criteria for the "Cardiac Function Analysis" and "Calcium Scoring" software, nor does it describe a specific study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, or agreement with ground truth.

The document mainly focuses on the regulatory submission process, intended use, device description, and substantial equivalence to predicate devices, rather than detailed performance studies against specific acceptance criteria.

Therefore, many of the requested sections cannot be filled from the given text.

Here's what can be extracted based on the provided information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria (e.g., minimum accuracy, sensitivity, or agreement percentages) are stated, and no specific performance metrics are reported in the provided text. The document states "The Cardiac Function Analysis and Calcium Scoring software packages will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release." This indicates that internal testing was conducted, but no results are presented.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not mentioned in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not mentioned in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not mentioned in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "Intended Use" section for both Cardiac Function Analysis and Calcium Scoring states that the software is intended for semi-automatic calculations and is a post-processing software tool where "regions of interest are selected by the user." This implies that the device is not purely standalone but is designed to assist a human user (human-in-the-loop). However, no standalone performance study results are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not mentioned in the document.

8. The sample size for the training set

Not mentioned in the document.

9. How the ground truth for the training set was established

Not mentioned in the document.

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The CSCS-001A is a non-invasive post processing package that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. This software can be used to generate both DiCOM reports and hard copy reports for the purpose of monitoring disease state over time.

This device is a non-invasive post processing package that allows the user to process volume sets to evaluate calcified plaque in the coronary arteries. These regions of interest can be selected manually or semi-automatically. Using multiple algorithms this software will calculate the calcium score. The software also provides hard copy reports or adds the data to the DiCOM file to allow tracking of the patient,

The provided document is a 510(k) Pre-market Notification for the Toshiba America Medical Systems, Inc. CSCS-001A Calcium Scoring Package. It outlines the device description, indications for use, and a statement of substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and the study proving the device meets them.

Here's a breakdown of what's missing and why it cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: This information is typically found in a clinical or performance evaluation section, often with specific metrics (e.g., accuracy, sensitivity, specificity, inter-observer variability) and target values. The document only mentions "performance standard" as 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard, which is a general regulatory standard, not specific performance criteria for calcium scoring.
• Sample size and data provenance for test set: The document does not describe any specific test set used for validating the device's performance.
• Number of experts and qualifications for ground truth: No information is provided about experts or ground truth establishment.
• Adjudication method for test set: No test set is described, so no adjudication method is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study or any effect size related to human reader improvement with AI assistance.
• Standalone performance study: The document focuses on the regulatory submission and substantial equivalence, not on a detailed performance study of the algorithm in a standalone capacity.
• Type of ground truth used: Since no test set or performance study is described, the type of ground truth is not specified.
• Sample size for training set: No training set information is included.
• How ground truth for training set was established: No training set information is included.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to general regulatory standards. It does not present the detailed clinical or performance study data, acceptance criteria, or ground truth establishment methods that would be necessary to answer your specific questions. These details are typically found in a separate performance study report or a more comprehensive technical document that might be referenced but is not included here.

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Voxar Calcium Scoring is a PC based software only application intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using IST image data and clinically accepted calcium scoring algorithms. Voxar calcium scoring is intended to be used by radiologists and other clinicians.

PC based software only application

This FDA document is a 510(k) clearance letter for the Voxar Calcium Scoring Product and does not contain the detailed study information required to answer your request. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document mentions that the device uses "clinically accepted calcium scoring algorithms" but does not detail the specific performance metrics, study design, or validation data that would demonstrate how the device meets acceptance criteria. To obtain this information, you would typically need to refer to the full 510(k) submission, scientific publications, or product documentation from Voxar, Ltd.

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The Viatronix V3D Calcium Scoring System is intended to be used by a trained physician for the review and analysis of CT images as an aid in cardiac analysis.

The V-3D Calcium Scoring System for Coronary Artery Calcification Scoring is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. The V-3D Calcium Scoring is an anatomy specific software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer. Upon receipt of a multi-slice CT scanner image for coronary arteries through DICOM, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive 2D and 3D views from the V-3D viewer and determines the density and location of calcium deposits within the coronary arteries and also scores measurements of calcium deposits. The calcium score provides a quantitative evaluation of the extent of plaque accumulation in the coronary arteries.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• t-tests concluded that the difference between the means of the V3D Calcium Scoring application and the predicate device was "zero or insignificant with a 99% level of confidence" for both volumetric and Agatston scores.
• F-tests concluded that the two sets of scores did "not differ in variability with a 99% level of confidence" for both volumetric and Agatston scores.
• For simulated phantom datasets, the output results "correlated perfectly to the pre-calculated score values." |
  | Reliability | "The product has shown itself to be reliable, easy to use and capable of calculating useful Calcium Score values." |
  | Usability | "The product has shown itself to be reliable, easy to use and capable of calculating useful Calcium Score values." |
  | Ability to Review and Analyze CT Images for Cardiac Calcium Scoring | Demonstrated through statistical equivalence to the predicate device in calculating calcium scores, which is a core function for reviewing and analyzing images for this purpose. |

Explanation of "Implicit" Acceptance Criteria: The document does not explicitly list numerical acceptance criteria (e.g., "accuracy must be >95%"). Instead, the primary acceptance criterion is substantial equivalence to existing predicate devices. This means the Viatronix V3D Calcium Scoring System must perform comparably to the predicate devices in terms of its ability to calculate calcium scores. The statistical tests performed (t-test and F-test) are designed to demonstrate this equivalence.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document mentions "Patients' Calcium Scoring Cases" were used for the clinical evaluation, but it does not specify the number of cases used.
• Data Provenance: The data comes from "Patients' Calcium Scoring Cases." It does not explicitly state the country of origin. The study appears to be retrospective, as "Same Cases were loaded into the Viatronix V3D Calcium Scoring application" after being evaluated with the predicate device.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not explicitly state the number of experts used to establish the ground truth for the test set.
• It implies that the "predicate device" was used to establish the initial scores, which were then compared to the scores from the Viatronix device. Therefore, the "ground truth" for the comparison was based on the performance of an already cleared device, not human experts providing a "true" score independently. This is a common approach for demonstrating substantial equivalence.

4. Adjudication Method:

• None directly stated. The "ground truth" for comparison was generated by the predicate device. The study design involved comparing the new device's output to the output of the predicate device, not adjudicating discrepancies between multiple human readers or between human and AI.

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

• No, an MRMC comparative effectiveness study was not done. The study's focus was on the equivalence of the device's numerical calculation output compared to a predicate device, not on how the device assists human readers or improves their performance.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The entire clinical study described involved the algorithm (Viatronix V3D Calcium Scoring application) calculating scores, which were then compared to scores calculated by the predicate device. There is no mention of human interaction during the Viatronix device's scoring process for the purpose of the study.
• Additionally, simulated "phantom" datasets with "known values" were used, where the device's output "correlated perfectly to the pre-calculated score values." This demonstrates standalone performance against an ideal, theoretical ground truth.

7. Type of Ground Truth Used:

• For the clinical evaluation, the ground truth was essentially the scores generated by the predicate device. This is a form of "reference standard" comparison to an already accepted technology.
• For the non-clinical tests, the ground truth was pre-calculated theoretical values derived from "known values" in simulated phantom datasets.

8. Sample Size for the Training Set:

• The document does not specify the sample size for the training set. It only mentions development and testing.

9. How Ground Truth for Training Set Was Established:

• The document does not provide details on how ground truth was established for any training data. It primarily focuses on the validation of the final product against predicate devices and simulated data.

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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.

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.

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