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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 Blood Flow Analysis 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. Addition to the tools in Synapse 3D Base Tools, Synapse 3D Blood Flow Analysis provides the imaging and assessment tools of blood flow velocity and directions based on multi-slice, multi-phase and velocity encoded MR images.

Synapse 3D Blood Flow Analysis is a software application that is used to work with Synapse 3D Base Tools (cleared by via K120361 on 04/06/2012). Synapse 3D Base Tools (K120361) is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices, and retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools (K120361), and the associated image-related information of the image data is registered in the database and used for display, image processing, analysis, etc.

Synapse 3D Blood Flow Analysis developed to calculate the blood flow volume and velocity for an arranged ROI. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer. The main functions of Synapse 3D Blood Flow Analysis are shown below.

• Display vessel images.
• Display the parameters such as flow velocity and volume calculated from the selected ROI.
• Display the time-intensity curve and the analysis result of the flow volume analysis and the flow velocity analysis.
• Display blood flow by flow velocity vector, streamlines and pathlines.
• Print or save reports.

Synapse 3D Blood Flow Analysis 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 document is a 510(k) summary for the Synapse 3D Blood Flow Analysis software. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not present in this document.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity for specific diagnostic tasks) or directly report performance against such criteria. The "Testing and Performance Information" section describes the software development process and verification/validation activities, stating:

"benchmark performance testing was conducted using actual clinical images to help demonstrate that the semi-automatic or automatic segmentation, detection functions implemented in Synapse 3D Blood Flow Analysis achieved the expected accuracy performance. Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests passed successfully according to the design specifications."

However, the specific "expected accuracy performance," the actual "test results," or the "Pass/Fail criteria" are not quantified or presented. The document focuses on functional and technical equivalence.

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

• Sample Size for Test Set: Not specified. The document mentions "actual clinical images" were used for benchmark performance testing but does not provide the number of cases or subjects.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only states "actual clinical images."

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

• This information is not provided in the document. The document describes the software's tools to "aid them [trained medical professionals] in reading, interpreting, and treatment planning," but it does not detail how ground truth was established for performance testing.

4. Adjudication Method for the Test Set

• This information is not provided 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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document states: "The subject of this 510(k) notification, Synapse 3D Blood Flow Analysis does not require clinical studies to support safety and effectiveness of the software." This indicates that the regulatory pathway did not necessitate a clinical efficacy study comparing human performance with and without the AI.

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

• The document implies that "benchmark performance testing" was conducted for "semi-automatic or automatic segmentation, detection functions," suggesting an assessment of the algorithm's performance on its own. However, the exact methodology and metrics of this "standalone" assessment are not detailed. It's generally assumed that software like this would have undergone internal standalone validation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• This information is not provided. While "actual clinical images" were used, the method for establishing the "ground truth" or reference standard for those images (e.g., expert consensus, comparison to another gold standard) is not described.

8. The Sample Size for the Training Set

• This information is not provided. The document focuses on verification and validation testing, not the training of a machine learning model, even though the device includes "semi-automatic or automatic segmentation, detection functions."

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

• This information is not provided, as the document does not discuss the training set or its ground truth.

Summary of what is present and what is missing:

The 510(k) summary primarily focuses on:

• Describing the device's functions and intended use.
• Demonstrating technical and functional equivalence to a predicate device (CAAS MR 4D Flow).
• Outlining the software development process, risk management, and cybersecurity measures.
• Stating that verification and validation activities were performed and passed "according to the design specifications" but without providing quantitative results or detailed study methodologies.

The document does not contain the detailed clinical study information (acceptance criteria, specific performance metrics, sample sizes for training/test sets, ground truth methodology, expert qualifications, or MRMC study results) that would be expected for a device making new clinical claims requiring such evidence. The statement "does not require clinical studies to support safety and effectiveness of the software" reinforces that the 510(k) pathway for this device relied on substantial equivalence rather than a new clinical performance study.

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Synapse 3D Perfusion Analysis 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 Perfusion Analysis accepts DICOM compliant medical images acquired from CT and MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Addition to Synapse 3D Base Tools, Synapse 3D Perfusion Analysis provides the parameter images by post-processing of dynamic scanned CT arteriography and magnetic resonance (MR) images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time To Peak (TTP),

Synapse 3D Perfusion Analysis is medical device software for Perfusion Analysis that provides the parameter images by post-processing of dynamic scanned CT arteriography and MR images acquired with contrast agents to aid the assessment of cerebral (CT and MR), myocardial (CT) and abdomen (CT) blood flows. The parameter images are Blood Volume (BV), Blood Flow (BF), Mean Transit Time (MTT), and Time to Peak (TTP). The perfusion parameter images can be presented to the trained medical professionals as the time-density curves (TDC) and perfusion characteristics maps (in parametric and summary) to assist them in assessing the blood flows. Synapse 3D Perfusion Analysis includes the following perfusion analysis applications.

• (1) Brain Perfusion (CT and MR) (unchanged from the FDA-cleared version K120637) is an application that analyzes the cerebral blood flow using the contrast-enhanced dynamic scanned CT and MR cerebral arteriography images. The Brain Perfusion post-processes the cerebral arteriography CT and MR images, and generates the parameter images of Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), MTT, and TTP.
• (2) 4D Perfusion (CT) is an application that analyzes the changes in the cerebral blood flow over time (in 4D) using the contrast-enhanced multi-phase 3D whole-brain images. The 4D Perfusion post-processes the cerebral arteriography CT and MR images, and generates the 4D (over time) parameter images of CBV, CBF, MTT, and TTP.
• (3) Abdominal Perfusion (CT) is an application that analyzes the blood flow of abdominal organs over time (in 4D) using the contrast-enhanced multi-phase 3D abdomen images. The Abdominal Perfusion post-processes the abdominal CT images, and generates the parameter images of Tissue Blood Volume (TBV), Tissue Blood Flow (TBF), MTT, and TTP.
• (4) Cardiac Perfusion (CT) is an application that analyzes the myocardial blood flow using the multi-phase 3D heart images. The Cardiac Perfusion post-processes the contrast-enhanced Myocardial CT images, and generates the parameter images of Myocardial Blood Volume (MBV), Myocardial Blood Flow (MBF), MTT, and TTP.

Synapse 3D Perfusion Analysis runs on Windows standalone and server/client configuration installed on a commercial general-purpose Windows-compatible computer. Synapse 3D Perfusion Analysis is an optional software module that works with Synapse 3D Base Tools (cleared by CDRH via K120361 on 04/06/2012) which is connected through DICOM standard to medical devices such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices, and it retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools, and the associated image-related information of the image data is registered in the database and is used for display, image processing, analysis, etc. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.

The provided text describes the Fujifilm Synapse 3D Perfusion Analysis device and its 510(k) submission. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of cases or patients. The document refers to "all of the test cases" but does not quantify them.
• Data Provenance: "actual clinical images" were used for benchmark performance testing. No specific country of origin or whether it was retrospective or prospective is mentioned.

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

Not explicitly stated. The ground truth ("Reference data (Pt)") was derived from a perfusion calculation model using arbitrary CT signal values, not directly from expert consensus on clinical images in the performance testing section.

4. Adjudication method for the test set

Not applicable. The ground truth for performance testing was established computationally through a perfusion calculation model, not through expert adjudication of cases.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on the performance of the algorithm itself.

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

Yes, a standalone performance test was done. The "benchmark performance testing" calculated the "Result data (Pc)" by Synapse 3D Perfusion Analysis using input data (Pi) and compared it to "Reference data (Pt)" derived from a perfusion calculation model. This evaluates the algorithm's accuracy in isolation.

7. The type of ground truth used

For the benchmark performance testing, the ground truth (Reference data (Pt)) was derived from a perfusion calculation model using input data (Pi: an image created using an arbitrary CT signal value).

8. The sample size for the training set

Not mentioned in the provided text.

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

Not mentioned in the provided text.

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Synapse 3D Liver and Kidney Analysis is medical imaging software used with Synapse 3D Base 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 and Kidney Analysis accepts DICOM compliant medical images. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

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

Synapse 3D Liver and Kidney Analysis (V4.0) (this submission) is updated software of previously-cleared Synapse 3D Liver Analysis (cleared by CDRH via K110186 on 04/07, 2011) with expanded IFU and revised device name. The new feature in Synapse 3D Liver and Kidney Analysis (V4.0) are Kidney Analysis (CT) function and Liver Analysis (MR).

Synapse 3D Liver and Kidney Analysis is medical application software running on Windows standalone and server/client configuration installed on a commercial general-purpose Windowscompatible 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 to develop treatment plans.

Synapse 3D Liver and Kidney Analysis is an optional software module that works with Synapse 3D Base Tools (cleared by CDRH via K120361 on 04/06/2012) which is connected through DICOM standard to medical devices such as CT, MR. CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medial devices, and it retrieves image data via network communication based on the DICOM standard. The retrieved image data are stored on the local disk managed by Synapse 3D Base Tools, and the associated information of the image data is registered in the database and is used for display, image processing, analysis, etc. Synapse 3D Liver and Kidney Analysis can handle images of CT and MR. The software can display the images on a display monitor, or printed them on a hardcopy using a DICOM printer or a Windows printer.

The liver and kidney analysis tools both segment the organs, peripheral organs and vessels using similar body part recognition algorithms already available in the FDA-cleared Base Tools (K120361) and the Liver Analysis (CT) (K110186). The technical characteristics and principles of operations are described in details in the Device Description section, which includes the Liver Analysis (CT and MR) and Kidney Analysis (CT). Based on the cleared functions, Synapse 3D Liver and Kidney Analysis enhances the custom workflows and UI to improve the usability.

Synapse 3D Liver and Kidney Analysis with Synapse 3D Base Tools can be integrated with Fujifilm's Synapse PACS, and can be used as a part of a Synapse system. Synapse 3D Liver and Kidney Analysis also can be integrated with Fujifilm's Synapse Cardiovascular for cardiology purposes. In summary, this 510(k) submission introduces the Synapse 3D Liver and Kidney Analysis with the added capability of performing Liver (MR) and Kidney (CT) Analysis.

The provided text describes a 510(k) premarket notification for the "Synapse 3D Liver and Kidney Analysis" software. While it states that "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed," it does not provide specific acceptance criteria values or detailed performance metrics for the device. Therefore, a table of reported device performance against acceptance criteria cannot be generated as the specific criteria and performance values are not given.

However, based on the provided text, here's what can be inferred and stated regarding the study:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not provide specific numerical acceptance criteria or quantitative reported device performance values for metrics like accuracy, sensitivity, or specificity. It broadly states that "Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed."

The testing included:

• System level functionality test
• Segmentation accuracy test
• Measurement accuracy test
• Interfacing test
• Usability test
• Serviceability test
• Labeling test
• Test for risk mitigation method analyzed and implemented in the risk management process
• Bench performance testing using actual clinical images

Without specific numerical cut-offs or reported results for each of these tests, a table with quantitative data cannot be created.

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

The document mentions "bench performance testing using actual clinical images." However, it does not specify the sample size used for the test set or the provenance of the data (e.g., country of origin, retrospective or prospective nature).

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

The document does not specify the number of experts used to establish ground truth or their qualifications. It generally states the software is "intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them."

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study:

The document describes the device as "medical imaging software used with Synapse 3D Base Tools that is intended to provide trained medical imaging professionals... with tools to aid them." It implies standalone performance as it is a software that provides segmentation and analysis tools. "Segmentation accuracy test" and "measurement accuracy test" would inherently evaluate the algorithm's performance without direct human interaction for generating the output, although the results are ultimately used by humans. However, it does not explicitly use the term "standalone study" or present results distinctly as such.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of "segmentation accuracy test" and "measurement accuracy test," it is highly probable that expert consensus or expert-derived segmentations/measurements were used as ground truth on the clinical images, but this is not explicitly stated.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

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Synapse 3D Tensor Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from MR for the purpose of viewing of local water diffusion properties and directional dependence of the diffusion in the white matter. It is intended to be used by trained medical professionals in reading, interpreting, reporting, screening and treatment planning.

Addition to the general 2D and 3D image processing and measurement tools available in Synapse 3D Base Tools, Synapse 3D Tensor Analysis provides custom workflows, UI, and reporting functions for tensor analysis with neck and head MR images. It includes display of diffusion and FA color map images, white matter tractography, dynamic review in MR, vessel and body visualization with registration of MR, CT, XA, PET and NM.

Synapse 3D Tensor Analysis is an optional software module that works with Synapse 3D Base Tools, cleared by CDRH via K120361 on 04/06/2012. Synapse 3D Tensor Analysis, Synapse 3D Base Tools and other optional software modules consist of the Synapse 3D product family.

Synapse 3D is medical application software running on a Standalone PC or Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers provides custom workflows, UI, and reporting functions for trained medical professionals to aid them in reading, interpreting, reporting, screening and treatment planning.

Synapse 3D Tensor Analysis supports the display of diffusion and Fractional anisotropy (FA) colormap images, white matter tractography, dynamic review, vessel and body visualization with registration of MR, CT, XA, PET and NM. Tensor Analysis tool enables tensor analysis from diffusion-weighted MR images and tractography-based extraction and observation of local water diffusion properties and directional dependence of the diffusion in the white matter. Additional images (mainly CT images) can be loaded, and skin, bone, brain parenchyma, tumor, and cerebral vessels can be extracted in craniotomy simulations.

The main functions are shown below.

• Display FA and diffusion colormap images
• Extract and observe white matter
• Calculate FA value, number of fibers, area, and volume in the specified ROI
• Simultaneous display of white matter and skin, bone, brain parenchyma, tumor, artery, vein, and other reqions
• Craniotomy simulations involving cutting of skin and bone regions, brain surface clipping by depth, and tumor plane clipping

The provided text is a 510(k) summary for the FUJIFILM Medical Systems U.S.A., Inc.'s Synapse 3D Tensor Analysis device. It details the device's intended use and claims substantial equivalence to predicate devices. However, the document does not include quantitative acceptance criteria or detailed study results that prove the device meets specific performance thresholds.

Here's a breakdown of what is and is not present, based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. 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."
• "a comparative performance testing was conducted between the Synapse 3D Tensor Analysis and the predicate device, and the comparison test result supported the substantial equivalence of the devices' performance characteristics."

However, no specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error rates) are listed, nor are the actual performance metrics (e.g., specific accuracy percentages, mean differences) from the tests.

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

This information is not explicitly provided in the document. The text mentions "actual clinical images" were used for bench performance testing but does not specify the number of images, cases, or their origin (country, retrospective/prospective).

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

This information is not provided in the document. The general statement about testing implies that the results were evaluated against some standard, but it doesn't specify if expert consensus was used to establish ground truth for the test set or the qualifications of such experts if they were involved.

4. Adjudication Method:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

This information is not provided. The document mentions "comparative performance testing was conducted between the Synapse 3D Tensor Analysis and the predicate device," but it does not specify if this was an MRMC study or if it involved human readers. Therefore, an effect size of human improvement with AI assistance cannot be determined from this document.

6. If a Standalone Study Was Done:

Yes, a standalone performance assessment was conducted for the Synapse 3D Tensor Analysis software. The document states:

• "Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process."
• "In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance."

This indicates that the software's performance was evaluated on its own.

7. The Type of Ground Truth Used:

The type of ground truth used is not explicitly stated. However, given the nature of the device (medical imaging software for viewing water diffusion properties and tractography), potential ground truth sources could include expert consensus, follow-up imaging, or correlation with clinical outcomes, but the document does not confirm this. The phrase "expected accuracy performance" suggests a comparison to some established accurate output, but the source of that accuracy (ground truth) is not specified.

8. The Sample Size for the Training Set:

This information is not provided. The document describes testing and validation activities but does not mention the training of an algorithm or the size of a training set. This is consistent with a device that provides visualization and processing tools rather than an AI/ML algorithm that requires a training set.

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

As no training set is mentioned for an AI/ML algorithm, this information is not applicable/provided. The device is described as "medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images," implying a tool for visualization and analysis rather than an autonomous diagnostic AI.

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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.

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Synapse 3D Colon Analysis is medical imaging software used with Synapse 3D Base Tools to accept, display, and process DICOM compliant 2D and 3D medical images acquired from CT for the purpose of viewing of a colon to detect polyps, masses, cancers, and other lesions. It is intended to be used by trained medical professionals in reading, interpreting, reporting, and screening.

Synapse 3D is medical application software running on Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained medical professionals to aid them in reading, interpreting, reporting, and treatment planning.

Synapse 3D Colon Analysis is supporting virtual colonoscopy using CT data. Device descriptions described in this section discuss Synapse 3D Colon Analysis operating with Synapse 3D Base Tools (K120361). Some features in Synapse 3D Base Tools (K120361) are noted so the reviewer knows that Synapse 3D Base Tools (K120361) is not the focus of this submission. The device name, Synapse 3D Colon Analysis, is used in this document where necessary to specify the device of this submission.

Synapse 3D Base Tools (K120361) is connected to various DICOM compatible medical devices, such as CT, MR, CR, US, NM, PT, XA, etc. and to a PACS system storing data generated by these medical devices. It retrieves image data via network communication based on the DICOM standard and the retrieved image data are stored on the local disk managed by Synapse 3D Base Tools (K120361). The associated information of the image data is registered in the database and is used for display, image processing, analysis, etc.

Synapse 3D Colon Analysis can handle images of CT. Images newly created by Synapse 3D Colon Analysis not only can be displayed on a display, but also can be printed on a hardcopy using a DICOM printer or a Windows printer.

Synapse 3D Colon Analysis with Synapse 3D Basic Tools (K120361) and above can be integrated with Synapse PACS V3.2.1 and above and with Synapse Cardiovascular system.

In summary, this 510(k) submission focuses on the Synapse 3D Colon Analysis with the capability of performing analysis on the CT images of the colon and supporting the trained medical professionals in reading, interpreting, reporting, and screening.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the FUJIFILM Synapse 3D Colon Analysis, outlining its substantial equivalence to a predicate device, not a performance study report with detailed acceptance criteria and results.

However, based on the information provided, here's what can be extracted and inferred regarding testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states "Pass/Fail criteria were based on the requirements and intended use of the product." However, it does not list the specific quantitative acceptance criteria for segmentation accuracy, measurement accuracy, or other performance metrics. It only concludes that "Test results showed that all tests successfully passed."

Therefore, a table cannot be fully populated from the given text.

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

• Sample Size: Not explicitly stated. The document mentions "performance comparison testing on retrospective images," but does not quantify the number of images or cases used in this test set.
• Data Provenance: Retrospective. The text indicates "performance comparison testing on retrospective images." The country of origin is not mentioned.

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

This information is not provided in the document. The text does not detail how ground truth was established for the retrospective images used in testing.

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

This information is not provided 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:

• MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or at least not described in this 510(k) summary. The testing mentioned was a "performance comparison testing on retrospective images to help demonstrate that the proposed device is substantially equivalent to the predicate device," implying a technical or functional comparison, not a reader study.
• Effect Size: Not applicable as no such study was conducted or reported.

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

Yes, the document states "Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test... In addition, we conducted the performance comparison testing on retrospective images." This implies various standalone tests of the algorithm's performance (e.g., segmentation accuracy, measurement accuracy are metrics for the algorithm itself).

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

The specific type of ground truth used for the "segmentation accuracy" and "measurement accuracy" tests is not explicitly stated. It can be inferred that for accuracy tests, some form of reference standard (e.g., expert-drawn contours or measurements, or potentially pathology if the comparison was to actual polyp presence) would have been used, but this is not detailed.

8. The sample size for the training set:

The document describes pre-market testing and comparison to a predicate device. It does not provide any information about a training set size, as this type of 510(k) summary typically focuses on validation or verification, not development or training data.

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

Not applicable, as information on a training set is not provided.

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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 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.

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

• use non-contrast and contrast enhanced computed tomographic images of the lung, provide custom workflows and UI, and reporting for lung analysis including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung.
• 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 (V3.0) is the updated version of previously-cleared Synapse 3D Lung and Abdomen Analysis software (cleared by CDRH via K103720 on 03/16/2011).

Synapse 3D Lung and Abdomen Analysis is used in addition to Synapse 3D Base Tools (K120361, cleared on April 6, 2012) to analyze the images acquired from CT. Synapse 3D Lung and Abdomen Analysis 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 Lung and Abdomen Analysis (V3.0) is an application that performs the CT Jung analysis/airway and abdomen 2D and 3D fat analysis.

• Lung analysis/Airway .
  Lung analysis/Airway is an application using non-contrast and contrast enhanced computed tomographic images of the lung which provides custom workflows and UI, and reporting functions including boundary detection and volume calculation for pulmonary nodules in the lung based on the location specified by the user, segmentation of bronchial tubes in the lung, approximation of air supply region by the user specified bronchial tube, identifying, displaying and processing low absorption regions in the lung,

• 2D Fat Analysis (Unchanged from the cleared version K103720) . 2D Fat Analysis is an application which can use single slice (2-dimensional) noncontrasted CT images to calculate subcutaneous fat and visceral fat areas.

• 3D Fat Analysis (Unchanged from the cleared version K103720) . 3D Fat Analysis is an application which can use volume (3-dimensional) non-contrasted CT images to calculate subcutaneous fat and visceral fat areas and volumes.

The following common image processing functions are available to support the analysis of the lung and abdomen CT images. These functions belong to and are provided by Synapse 3D Base Tools (K120361) that is used with Synapse 3D Lung and Abdomen Analysis (V3.0).

• Window width and window level. .
• Zooming, panning, flip, rotate. .
• Measurement of lengths, areas, etc. .
• Adding annotations on an image. .
• Extraction and Deletion of 3D objects: Editing of mask areas using the smart out feature. .
• 3D clipping: The display area can be specified for 3D display. .
• Creation of video files: Video files with 2D or 3D display can be created. .

The provided text describes the acceptance criteria and the study conducted for the Synapse 3D Lung and Abdomen Analysis (V3.0) device, specifically for its new lung volume analysis feature (approximation of air supply region).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Simulated Test: "a simulated image data set for air supply region approximation with known air supply volume for each bronchus." (Specific number of cases or volumes not given, but implies a designed set.)
• Real Human Body CT Image Test: "five lung CT image data sets of real human body."
• Data Provenance: Not explicitly stated for either test in terms of country of origin or whether it was retrospective or prospective. The term "real human body" suggests clinical data.

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

• Simulated Test: Ground truth was established by "known air supply volume for each bronchus," implying a computational or theoretical basis rather than expert consensus on images. Experts were not used to establish this ground truth.
• Real Human Body CT Image Test: The ground truth for the "reference volumes of five pulmonary lobes for each test data set" was established manually "using the validated segmentation tools." The number of experts is not specified, nor are their particular qualifications (e.g., radiologist with X years of experience). The phrasing "manually using the validated segmentation tools" suggests a skilled user performing the segmentation, rather than a multidisciplinary expert panel.

4. Adjudication Method for the Test Set

• The document implies that the "validated segmentation tools" were used to establish the reference volumes for the real human body CT images. No formal adjudication method like "2+1" or "3+1" is described. The simulated test had "known values," so no adjudication was needed.

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

• No MRMC comparative effectiveness study is mentioned for the new lung volume analysis feature. The testing described focuses on the accuracy of the algorithm's measurements against defined ground truths.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the studies described are essentially standalone performance evaluations of the algorithm for the new lung volume analysis feature. In the "Test using lung CT image data sets of real human body," the device's output (air supply region approximation) is compared against "reference volumes" established prior to or independently of the device's main function being tested. The user's role is primarily to specify the root of each bronchus, which is an input for the algorithm, but the calculation and approximation itself are done by the device.

7. Type of Ground Truth Used

• Simulated Test: "Known air supply volume" (presumably computationally derived or theoretically defined).
• Real Human Body CT Image Test: Expert consensus via "manual... segmentation and volume calculation using validated segmentation tools" for pulmonary lobes. This serves as a reference standard for comparison with the device's approximation of air supply regions.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for the lung volume analysis feature. The studies described are verification/validation tests, not details of model training.

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

• Since the document does not provide information on the training set, it also does not describe how its ground truth was established.

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Synapse 3D Nodule Analysis 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 Nodule Analysis accepts DICOM compliant medical images acquired from CT and PT.

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

Addition to Synapse 3D Base Tools, Synapse 3D Nodule Analysis is intended to;

• use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows and Ul, and reporting functions for nodule analysis including boundary detection of nodules based on the location specified by the user, measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
• use positron emission tomography (PT) images, provide custom workflows and UI, and reporting functions for nodule analysis including SUV measurement of nodules with sphere VOI based on the location specified by the user, temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.

Synapse 3D Nodule Analysis is an optional software module that works with Synapse 3D Base Tools (V3.0) (K120361, cleared on April 6, 2012). Synapse 3D Nodule Analysis, Synapse 3D Base Tools (V3.0), as well as other optional software modules, all belong to the Synapse 3D product family.

Synapse 3D is the medical application software running on Windows server/client configuration installed on a commercial general-purpose Windows-compatible computer. It offers software tools which can be used by trained medical professionals to interpret medical images obtained from various medical devices, to create reports, or to develop treatment plans.

The key features in Synapse 3D Nodule Analysis include boundary detection of nodules, measurement of nodules, temporal comparison of nodule images, and fusion of CT and PT nodule images on the non-contrast and contrast enhanced CT or PT images.

Synapse 3D Nodule Analysis offers physicians the following clinical applications in addition to the features available from Synapse 3D Base Tools (V3.0) to analyze the image data retrieved from CT and PT devices.

• . Response Evaluation Criteria in Solid Tumors (RECIST) Tracker Use non-contrast and contrast enhanced computed tomography (CT) images, provide custom workflows, user interface (UI), and reporting functions for nodule analysis including boundary detection of nodules (based on the location specified by the user), measurement of nodules, temporal comparison of nodule images, and fusion of a CT nodule image on a PT nodule image.
• Positron Emission Response Criteria in Solid Tumors (PERCIST) Tracker . Use positron emission tomography (PT) images, provide custom workflows user interface (UI), and reporting functions for nodule analysis including standardized uptake value (SUV) measurement of nodules with sphere VOI (based on the location specified by the user), temporal comparison of nodule images, and fusion of a PT nodule image on a CT nodule image.

The provided text states that the device was 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 Nodule Analysis software, which is found to be safe and effective and substantially equivalent to the currently-cleared predicate device. However, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details. That information is not present in the provided text.

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