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Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including: Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart.

-Functional cardiac analysis for MR heart images: which is intended to evaluate the functional characteristics of heart. -Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.

-Coronary artery analysis for MR heart images: which is intended for the qualitative analysis of coronary arteries.

-Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.

-Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

-Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the valves, measurement of the calcification area in the aorta and the valves. Placement of a virtual prosthetic valve.

-MR parametric maps: which is provided for pixel maps for myocardial MR relaxation times.

Synapse 3D Cardiac Tools (V5.4) is an optional software module that works with Synapse 3D Base Tools (V3.0) (cleared by CDRH via K120361 on 04/06/2012) that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools (V5.4) accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA. The main functions of Synapse 3D Cardiac Tools are shown below.

• Cardiac Function (CT)
• Cardiac Function (MR)
• Coronary Artery Analysis (CT)
• O Calcium Scoring
• Cardiac Fusion
• Coronary Artery Analysis (MR)
• 0 Aortic Valve Analysis
• MR Flow Analysis (MR)
• 4-Chamber Analysis (CT)
• Cardiac Ablation Analysis (CT)
• Cardiac Tx-maps
• Mitral Valve Analysis

Synapse 3D Cardiac Tools runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained professionals, such as radiologists, clinicians or general practitioners to interpret medical images obtained from various medical devices to create reports or develop treatment plans.

The provided text confirms that the device, Synapse 3D Cardiac Tools (V5.4), was tested for functionality to support its claim of substantial equivalence to its predicate device, Synapse 3D Cardiac Tools (V3.2). However, the document does not provide explicit acceptance criteria in a table format, nor does it detail a specific study with quantitative results to prove the device meets such criteria. It primarily focuses on comparing features and technical characteristics with its predicate and outlines general software development and testing processes.

Here's an attempt to answer your questions based only on the provided text, highlighting what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "benchmark performance testing" for segmentation, detection, and registration, implying a quantitative assessment (achieved "expected accuracy"). However, the specific numerical acceptance criteria or performance metrics are not disclosed in this document. The "All tests passed successfully" statements refer to the system-level validation against general design specifications and intended use, not necessarily against predefined numerical accuracy thresholds for clinical tasks.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "actual clinical images" were used for benchmark performance testing. However, the sample size (number of cases/images) used for any of the testing (system-level, benchmark, etc.) is not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only states "actual clinical images."

3. Number of Experts and Qualifications for Ground Truth

The document states that "Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning." However, it does not specify how many experts were used to establish the ground truth for the test set, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth of the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not described in the provided text. The document does not mention any studies evaluating human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The text describes "benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection, and registration functions implemented in Synapse 3D Cardiac Tools achieved the expected accuracy performance." This implies a standalone evaluation of the algorithm's performance for these specific functions. However, the results (e.g., specific accuracy metrics) of this standalone performance are not provided.

7. Type of Ground Truth Used

For the "benchmark performance testing" of segmentation, detection, and registration, it implies a ground truth was used to assess "expected accuracy performance." However, the exact type of ground truth (e.g., expert consensus, pathology, outcome data) is not explicitly stated. It's common in such tools for ground truth to be established by expert manual annotation or consensus, but this is not confirmed in the text.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set, its sample size, or how its ground truth was established. This suggests that the device, or at least the version being evaluated, might be more of a sophisticated image processing and visualization tool with semi-automatic functions rather than a deep learning-based AI device requiring extensive training data in the modern sense. The "benchmark performance testing" focuses on the accuracy of its segmentation, detection, and registration functions, which could be rule-based or model-based, but the origin of any models is not described.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not available in the provided text.

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Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools for specific clinical applications which provide targeted workflows, custom UI, targeted measurements and reporting functions including:

• A Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
• A Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
• A Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
• A Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
• A Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
• A Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data
• A Aortic Valve Analysis for contrast CT heart images: which is intended for visualization of the heart, aorta regions, and contour of the aorta, measurement of the vicinity of the aortic valve, measurement of the calcification area in the aorta.

Synapse 3D Cardiac Tools is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K120636 on 07/05/2012).

Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning of DICOM compliant medical images.

Synapse 3D Cardiac Tools is an application that supports the cardiac function, cardiac fusion, and coronary artery analysis of both the computed tomography (CT) and magnetic resonance (MR) images. Synapse 3D Cardiac Tools also supports the calcium scoring for non-contrast CT images.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Preamble: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily K120636 and K120367. The testing described is general to software verification and validation, rather than a specific clinical performance study with detailed acceptance criteria for diagnostic metrics. The document emphasizes that the device is an "updated version" and an "application that supports" trained medical professionals, suggesting it's a tool for analysis rather than an autonomous diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) document does not contain a specific table of quantitative acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for a standalone AI algorithm. It describes general verification and validation activities for software and accuracy for measurements.

The document states: "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed."

Based on the information, here's a conceptual table. Since quantitative diagnostic performance metrics are not given, the "Reported Device Performance" is inferred from the overall statement of successful testing.

2. Sample Size for the Test Set and Data Provenance

The document states: "In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance."

• Sample Size for Test Set: Not specified. The exact number of "actual clinical images" used for bench performance testing is not mentioned.
• Data Provenance: The images were "actual clinical images." The country of origin and whether they were retrospective or prospective are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the "actual clinical images."

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the "actual clinical images."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the software's inherent functionality and measurement accuracy as a tool rather than its impact on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance." This implies a standalone assessment of the device's accuracy in segmentation and measurement.

• Yes, a standalone assessment of the device's performance was conducted, specifically for "segmentation accuracy test" and "measurement accuracy test." However, the specific metrics (e.g., Dice scores, absolute difference in measurements) and their success thresholds are not detailed.

7. The Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used (e.g., pathology, clinical outcomes). Given the context of "segmentation accuracy test" and "measurement accuracy test" using "actual clinical images" for cardiac analysis, the ground truth would most likely have been expert consensus or reference measurements manually performed by qualified experts on these clinical images.

8. The Sample Size for the Training Set

The document does not mention or specify a training set size. This is typical for 510(k) submissions for image processing tools that might use rule-based algorithms or pre-trained models. If machine learning was involved in specific features, the training data and methods are not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described.

Ask a specific question about this device

Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to the tools in Synapse 3D Base Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows, custom Ul, targeted measurements and reporting functions including:

• Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
• Functional cardiac analysis for non-contrast MR heart images: which is intended to evaluate the functional characteristics of heart
• Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
• Coronary artery analysis for MR heart images: which is intended for the qualitative and quantitative analysis of coronary arteries
• Calcium scoring for non-contrast CT heart images: which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
• Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.g. NM image, Bulls eye) and anatomical data.

Synapse 3D Cardiac Tools (V3.0) is the updated version of previously-cleared Synapse 3D Cardiac Tools software (cleared by CDRH via K103465 on 01/31/2011).
Synapse 3D Cardiac Tools is used in addition to the Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT and MR. Synapse 3D Cardiac Tools is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning of DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of mammography images.

Synapse 3D Cardiac Tools (V3.0) is an application that supports the cardiac function, cardiac fusion, and coronary artery analysis of both the computed tomography (CT) and magnetic resonance (MR) images. Synapse 3D Cardiac Tools also supports the calcium scoring for noncontrast CT images.

The provided text describes the Synapse 3D Cardiac Tools (V3.0) and its substantial equivalence to a predicate device, but it does not include specific acceptance criteria or details of a study (e.g., performance metrics, statistical analysis) that proves the device meets those criteria.

Instead, the document states: "Synapse 3D Cardiac Tools is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Synapse 3D Cardiac Tools software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device."

Therefore, I cannot provide the requested table or detailed study information. I can only infer what the general approach to testing was.

Based on the provided text, here is what can be extracted and what information is not available:

1. Table of acceptance criteria and reported device performance:

Note: The document only states that testing was "successful" and that characteristics were "established." It does not provide quantitative metrics for device performance against specific targets.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "images acquired from CT and MR" but provides no details on how these images were assembled for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

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

• Adjudication method: Not specified.

5. 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:

• MRMC study: Not mentioned or implied. The document focuses on the software's functionality and substantial equivalence rather than comparative effectiveness with human readers.

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

• Standalone performance: The testing described focuses on the device's adherence to its specifications rather than a specific standalone performance study with defined metrics against a ground truth. The device is a "medical image processing and analysis software" intended to provide "tools to aid them [trained medical professionals] in reading, interpreting, reporting, and treatment planning," suggesting it's designed as an aid, not a standalone diagnostic.

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

• Type of ground truth: Not specified. Given the nature of the application (cardiac function, coronary artery analysis, calcium scoring), it would typically involve comparisons to established clinical measurements or expert interpretations, but the document does not elaborate.

8. The sample size for the training set:

• Sample size for training set: Not specified. There is no mention of a "training set" as the device is presented as an updated version of a previously cleared software, implying its development might predate or not entirely rely on modern machine learning training paradigms in the same explicit way.

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

• How ground truth was established for training set: Not specified.

In summary: The provided 510(k) summary focuses on the device description, its indications for use, its technological characteristics (primarily stating no new safety/efficacy issues compared to predicates), and that it underwent successful verification and validation against its Software Requirements Specification to demonstrate substantial equivalence. It lacks the detailed performance study information typically found in submissions for AI/ML devices requiring specific performance metrics against a robust ground truth.

Ask a specific question about this device

Synapse 3D Cardiac Tools is medical imaging software used with Synapse 3D Basic Tools that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning. Synapse 3D Cardiac Tools accepts DICOM compliant medical images acquired from a variety of imaging devices including, CT, MR, NM, and XA.

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to the tools with Synapse 3D Basic Tools, Synapse 3D Cardiac Tools provides the tools for specific clinical applications which provide targeted workflows. custom UI, targeted measurements and reporting functions including:

• Functional cardiac analysis for CT left ventriculography images: which is intended to evaluate the functional characteristics of heart
• Functional cardiac analysis for non contrasted MR heart images: which is intended to evaluate the functional characteristics of heart
• Coronary artery analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries
• Calcium scoring for non contrasted CT heart images: which is intended for non invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms
• Cardiac Fusion: which is intended to analyze cardiac anatomy and pathology with a fused image of functional data (e.q. NM imaqe. Bulls eye) and anatomical data.

Synapse 3D Cardiac Tools is with Fujifilm's Synapse 3D Basic Tools (K101662, cleared by CDRH on July 26, 2010) and can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.1.0 and above as a part of a Synapse system. Synapse 3D Cardiac Tools also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.

Synapse 3D Cardiac Tools offers physicians the following clinical applications in addition to the features available from our cleared Synapse 3D Basic Tools (K101662) to analyze the image data retrieved from various connected devices.

Functional cardiac analysis (CT)
Functional cardiac analysis (CT) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from CT left ventriculography images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, etc.

Functional cardiac analysis (MR)
Functional cardiac analysis (MR) is an application for cardiac function evaluation which obtains the boundary between left ventricle and cardiac wall from non-contrasted MR images retrieved from multiple time phases and calculates ejection fraction, end-diastolic volume, end-systolic volume, output volume per beat, etc.

Coronary artery analysis (CT)
Coronary artery analysis is an application using CT coronary arteriography images to extract the path of the target blood vessels and to perform coronary artery evaluation.

Calcium Scoring
The calcium scoring is an application which uses non-contrasted CT images to display the calcification area in the coronary artery with color separation and calculates the calcification quantitative values using the Agatston score method.

Cardiac Fusion
Cardiac fusion is an application to create an image having the mutual characteristics of source images of heart. Source images could be original image of CT, MR or NM and the functional image derived from the original image.

I'm sorry, but relevant information specifying the acceptance criteria, study details, and device performance for the Synapse 3D Cardiac Tools is not present in the provided text. The document K103465 mainly provides general information, device description, indications for use, and regulatory correspondence.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone performance study.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

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