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Synapse 3D Liver Analysis 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 Liver Analysis accepts DICOM compliant medical images acquired from CT.

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

Addition to Synapse 3D Basic Tools, Synapse 3D Liver Analysis uses contrast enhanced computed tomographic images of the body and provides custom workflows and UI, and reporting functions for liver analysis including, liver segmentation, tumor segmentation, segmentation of intrahepatic vessels as well as the approximation of vascular territories.

Synapse 3D Liver Analysis is an application which uses the intravenous contrasted CT study of a liver to segment the liver and various blood vessels and to perform 3D display of the results. Using the information of segmented liver, hepatic vessels, tumors, and the morphological structure of vessel system and blood supply volume of each vessel, the user can analyze the liver, vessels and tumors and plan the treatment.

Synapse 3D Liver Analysis is used in addition to the previously-cleared features available from Synapse 3D Basic Tools (K101662) to analyze the images acquired from CT. Synapse 3D Liver Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, and treatment planning and accepts DICOM compliant medical images.

Synapse 3D Liver Analysis with Synapse 3D Basic Tools can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.2.1 and above, and can be used as a part of a Synapse system. Synapse 3D Liver Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.

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

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report to prove the device meets these criteria. The document is a 510(k) summary and FDA decision letter for the Synapse 3D Liver Analysis software. It primarily focuses on the regulatory submission, device description, indications for use, and substantial equivalence to a predicate device, rather than a detailed performance study.

However, based on the information available and the general type of device (medical image processing software), we can infer certain aspects and identify what is missing.

Here's an attempt to answer the questions, highlighting what is present and what is not:

Acceptance Criteria and Study Details for Synapse 3D Liver Analysis

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

The provided text does not include a table of acceptance criteria or reported device performance metrics. For a device like Synapse 3D Liver Analysis, which segments structures and provides analysis tools, typical acceptance criteria would involve:

• Accuracy of segmentation: e.g., Dice Similarity Coefficient (DSC), volumetric overlap, surface distance metrics for liver, vessels, and tumors.
• Precision/Reproducibility: Consistency of results across different users or repeated analyses.
• Performance/Speed: Time taken for segmentation and analysis.
• Usability: User satisfaction and efficiency with the interface.

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).

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

The document does not provide information on the number or qualifications of experts used to establish ground truth. For a device performing segmentation, ground truth would typically be established by radiologists, surgeons, or other specialists manually segmenting structures on images.

4. Adjudication method for the test set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for a test set.

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

The document does not indicate that a MRMC comparative effectiveness study was done. The device is described as providing "tools to aid them [medical professionals] in reading, interpreting, and treatment planning," suggesting an assistive role. However, no study demonstrating an improvement in human reader performance with the aid of the software is reported.

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

The document does not explicitly describe a standalone performance study for the algorithm. While it performs liver and vessel segmentation automatically (as implied by "segment the liver and various blood vessels"), no specific metrics for this standalone performance are provided.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. For segmentation tasks in medical imaging, ground truth is most commonly established through expert consensus (manual delineation by medical professionals, sometimes with pathology correlation if available).

8. The sample size for the training set

The document does not mention the sample size used for the training set. Given the date (2011), the use of deep learning (which requires large training sets) was not as prevalent as it is today, but some form of training data would have been necessary for segmentation algorithms.

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

The document does not describe how the ground truth for the training set was established. Similar to the test set, it would likely involve manual annotation by experts.

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Synapse 3D Lung and Abdomen Analysis 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 Lung and Abdomen Analysis accepts DICOM compliant medical images acquired from CT.

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

Addition to Synapse 3D Basic Tools, Synapse 3D Lung and Abdomen Analysis is intended to;

• use non-contrasted and contrast enhanced computed tomographic images of the lung, perform boundary detection and volume calculation for pulmonary nodes in the lung based on the location specified by the user and display low absorption areas.
• use non-contrasted CT images and calculate subcutaneous fat and visceral fat areas in 2D and both volumes in 3D.

Synapse 3D Lung and Abdomen Analysis is an application that can perform volume calculation for pulmonary nodes, display of low absorption areas, and other analysis for Lung contrasted and non-contrasted CT volume date. In addition, the application can calculate the area and volume (3D) of subcutaneous fat and visceral fat using abdomen CT images. The result can be displayed as a graph, and the fat quantity at each slice position can be presented.

Synapse 3D Lung and Abdomen Analysis is used in addition to the previously-cleared features available from Synapse 3D Basic Tools (K101662) to analyze the images acquired from CT. Synapse 3D Lung and Abdomen Analysis is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting, and treatment planning and accepts DICOM compliant medical images.

Synapse 3D Lung and Abdomen Analysis with Synapse 3D Basic Tools can be integrated with our cleared Fujifilm's Synapse Workstation, version 3.2.1 and above, and can be used as a part of a Synapse system. Synapse 3D Lung and Abdomen Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes.

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synapse 3D Lung and Abdomen Analysis device:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or numerical reported device performance in a table format. It focuses on the general statement that "All planned verification and validation tests for Synapse 3D Lung and Abdomen Analysis have passed and the design validation has been successfully completed."

However, based on the device's intended use, we can infer the functional performance aspects that would have been tested:

Study Information:

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

   • Sample Size: The document does not specify the sample size used for the test set (verification and validation testing).
   • Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.

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

   • The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

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

   • The document does not describe any adjudication method used for the test set.

4. 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:

   • The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The device is described as "tools to aid them in reading, interpreting, reporting, and treatment planning," implying an assistative role rather than a standalone AI for primary diagnosis that would typically necessitate such a study.

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

   • The document does not explicitly state that a standalone (algorithm only) performance study was conducted. The description emphasizes the device providing "tools to aid" medical professionals, suggesting it's intended for use with human interpretation rather than as a fully autonomous diagnostic tool.

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

   • The document does not specify the type of ground truth used for its verification and validation testing. Given the functions (volume calculation, boundary detection, fat measurement), it's highly likely that a form of expert consensus or highly accurate manual measurements by trained professionals on the CT images themselves would have served as ground truth.

7. The sample size for the training set:

   • The document does not provide information on the sample size used for the training set. This is a 510(k) for a medical image processing and analysis software, not typically a machine learning-based device where a training set is a central component of the submission. While such software may use algorithms developed with training data, the 510(k) summary focuses on the validation of the final product.

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

   • Since information about a training set or its sample size is not provided, the method for establishing its ground truth is also not described.

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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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