Search Results

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea Software Package has the following additional indications:

Auto MPR Brain application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.

Subtraction Viewer is a viewer application that is intended for viewing original, subtraction and fusion CT images, but such subtraction processing is not a part of this application. This application supports fusion display of original image and subtraction image generated by other applications.

The Vitrea Software Package, VSTP-002A V2.0, is a portfolio of applications software designed to be used in the Canon Medical Informatics Vitrea workstation. VSTP-002A currently includes post processing applications, Auto MPR Brain and Subtraction Viewer, which use CT image data, obtained from Canon CT Systems, to assist physicians in performing specialized measurements and analysis.

Auto MPR Brain is a software application that aligns CT brain images into a standard anatomical position for review.

Subtraction Viewer, also marketed as SCT Viewer, is a software application intended to view original, subtraction and fusion CT images. This application supports fusion display of original images and subtraction images generated by other applications and includes the ability to adjust fusion rate and ROI measurements of fusion images.

The provided text describes a 510(k) premarket notification for the "Vitrea Software Package, VSTP-002A V2.0". Based on the information provided, the acceptance criteria and study proving the device meets these criteria can be described as follows:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly derived from the "Performance Testing - Bench" section, which focuses on the "Evaluation of CE Boost Contrast-to-Noise Ratio (CNR)" for the Subtraction Viewer software.

Study Details:

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

   • Sample Size: "images of adult cases". No specific number of cases or images is provided.
   • Data Provenance: The images were "derived from a Canon CT scanner." The anatomical regions included "abdomen, brain, neck, chest, pulmonary embolism, and limb scans." The country of origin is not specified, nor is whether the data was retrospective or prospective.

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

   • The document does not mention the use of experts or the establishment of ground truth by experts for the performance testing. The evaluation described is a quantitative measurement (CNR) of the output from the "Subtraction Viewer" application.

3. Adjudication Method for the Test Set:

   • Not applicable, as no human reader evaluation or expert consensus for ground truth establishment is described. The performance test is a quantitative measurement of CNR.

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

   • No MRMC or human-in-the-loop study is mentioned. The performance evaluation focuses on the technical performance of the software (CNR measurement), not on how human readers interact with or benefit from the AI.

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

   • Yes, the described "Evaluation of CE Boost Contrast-to-Noise Ratio" is a standalone, algorithm-only performance assessment. It directly evaluates the output of the software (CE Boost images) by comparing CNR, without involving human interpretation or decision-making as part of the primary performance metric.

6. Type of Ground Truth Used:

   • The concept of "ground truth" as a clinical reference standard (e.g., pathology, outcomes data, or expert consensus on disease presence) is not directly applicable to the described performance test. The "ground truth" for the CNR evaluation is the original CE image against which the CNR of the CE Boost image is compared. The purpose of the test is to verify the software's ability to enhance contrast as intended.

7. Sample Size for the Training Set:

   • The document does not provide information about the training set size or methodology. This submission is for a "modification of a cleared device" (VSTP-002A V2.0 from VSTP-002A), and the focus of the testing section is on the performance validation of the modified features, specifically the CE Boost functionality within the Subtraction Viewer.

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

   • Not specified, as information regarding the training set and its ground truth establishment is not provided in this document.

Ask a specific question about this device

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea Software Package has the following additional indications:

Auto MPR application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.

The Vitrea Software Package, VSTP-002A, is a portfolio of applications software designed to be used in the Canon Medical Informatics Vitrea workstation. VSTP-002A currently includes a post processing application, Auto MPR, which use CT brain image data, obtained from Canon CT Systems, to assist physicians in performing specialized measurements and analysis.

Auto MPR is a software application that aligns CT brain images into a standard anatomical position for review.

Here's a breakdown of the acceptance criteria and the study details for the Vitrea Software Package, VSTP-002A, specifically focusing on the Auto MPR application, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document details the testing performed for the Auto MPR application within the Vitrea Software Package. The core function of Auto MPR is to align CT brain images into a standard anatomical position.

Study Details

The information provided is somewhat limited as it's a 510(k) summary, which often condenses detailed study information.

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

   • Sample Size: Not explicitly stated in the provided text. The document mentions "bench studies" and "various conditions," but specific numbers of images or cases used for evaluation are not given.
   • Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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

   • Not explicitly stated. The document refers to "established specifications" but does not detail how these specifications were derived or who established the ground truth for image alignment.

3. Adjudication Method for the Test Set:

   • Not explicitly stated. There is no mention of an adjudication process (e.g., 2+1, 3+1) for the ground truth.

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

   • No evidence of an MRMC study is provided. The submission focuses on device performance against specifications rather than a comparative effectiveness study with human readers. There is no mention of human improvement with or without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

   • Yes, a standalone study was performed. The "bench studies" described assess the Auto MPR's output image alignment and performance under various conditions, implicitly without human intervention beyond setting up the tests and evaluating the results against established specifications.

6. Type of Ground Truth Used:

   • The ground truth appears to be based on "established specifications" for what constitutes a "standard anatomical position" for CT brain images. The details of how these specifications were defined (e.g., based on anatomical landmarks, expert consensus on "correct" alignment) are not provided. It's not explicitly stated to be pathology or outcomes data.

7. Sample Size for the Training Set:

   • Not explicitly stated. The document describes the device as a "post processing software" but does not provide details about its development, including training set size if machine learning was used.

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

   • Not explicitly stated. Without information on a training set or the use of machine learning, there's no detail on how ground truth for training would have been established.

In summary, the 510(k) emphasizes that the Auto MPR application met its established technical specifications for aligning CT brain images into a standard anatomical position during bench testing. However, specific quantitative metrics for performance, details about the dataset used for testing (size, provenance), and the process of establishing ground truth (human expert involvement, adjudication) are not included in this summary document.

Ask a specific question about this device

This device is indicated to acquire and display cross-sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.

FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, brain, inner ear and extremities applications.

The spectral imaging system utilizes two scan modes, spectral imaging scan and dual energy scan.

The spectral imaging scan allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.

Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.

The dual energy scan, utilized for brain imaging, allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube cotations. The X-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast may be gained from the differences in X-ray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials. Performance of dual energy scan may be affected by body size and motion artifacts.

When used by a qualified physician, a potential application is to determine the course of treatment

PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac applications.

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.

The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.

The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.

Effective Z and Electron Density maps may aid in the differentiation of different tissues in the human body.

Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes eleven post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Spectral Stone Analysis, Spectral Composition Analysis, Embolization Planning Tool and Spectral Analysis which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

Here's a summary of the acceptance criteria and study information for the Vitrea Software Package, VSTP-001A, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for Vitrea Software Package, VSTP-001A

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria for improved performance. The "acceptance criteria" can be inferred from the studies conducted to show that the new/modified features (specifically related to Spectral Analysis and additional display options) meet specifications and perform as intended, or offer equivalent/improved performance compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a "test set" in the context of clinical images for the Vitrea Software Package. The performance testing mentioned primarily involved:

• Bench testing: This would involve laboratory-based tests on the software without human data.
• Phantom studies: These use artificial objects (phantoms) instead of human subjects.
• Clinical Images (for Aquilion ONE): For the associated CT scanner (Aquilion ONE), "Representative body, cardiac, low dose chest and head diagnostic images, reviewed by an American Board Certified Radiologist" were obtained. However, this refers to the acquisition capabilities of the CT scanner, not directly to the evaluation of the Vitrea Software Package's specific new features.

Therefore, for the Vitrea Software Package, there is no stated sample size for a clinical test set directly evaluating the software's new features. The primary evaluation focused on technical performance using phantoms.

Data Provenance: Not explicitly stated for specific test sets related to the Vitrea software. The studies mentioned are primarily technical (bench and phantom studies).

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

• For the Vitrea Software Package: The document does not specify the use of experts to establish ground truth for a test set directly related to the new software features. Evaluation appears to be based on technical specifications and phantom studies.
• For the Aquilion ONE (CT Scanner) clinical images: "An American Board Certified Radiologist" reviewed images for diagnostic quality. This indicates at least one expert was used, but the purpose was general diagnostic quality rather than establishing ground truth for specific algorithm performance metrics.

4. Adjudication Method for the Test Set

Not applicable, as no external expert-adjudicated test set is described for the Vitrea Software Package's new features.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described for the Vitrea Software Package. The document focuses on demonstrating substantial equivalence based on technical performance and phantom studies, and the new features are primarily tools for visualization and analysis, not AI assistance for human readers in a diagnostic setting that would typically require an MRMC study.

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

The performance testing primarily involved standalone algorithm components evaluated through bench testing and phantom studies. For example, the Spectral Analysis application's ability to generate monochromatic images, iodine maps, electron density images, etc., and the functionality of new display modes, would have been evaluated primarily in a standalone manner against technical specifications.

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

For the Vitrea Software Package:

• Technical specifications/expected outputs: The "ground truth" for the new features was primarily based on predefined technical specifications and expected outputs from phantom studies (e.g., accurate generation of monochromatic images, proper functioning of display modes).
• Phantom studies: Phantoms are designed with known properties, serving as a form of "ground truth" for evaluating image quality metrics.

No mention of expert consensus, pathology, or outcomes data being used as ground truth for the Vitrea Software Package's new features.

8. The Sample Size for the Training Set

Not applicable. The document describes a "Software Package" with modifications to existing features, not a deep learning algorithm that requires a "training set." While the Aquilion ONE CT scanner mentions AI-based reconstruction (AiCE, PIQE), the FDA submission for the Vitrea Software Package itself does not describe a training set for the software's functional updates.

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

Not applicable, as no training set is mentioned for the Vitrea Software Package in this submission.

Ask a specific question about this device

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.

The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.

The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.

Effective Z and Electron Density maps may aid in the differentiation of different tissues in the human body.

Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning Tool which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

The provided text describes the Vitrea Software Package, VSTP-001A, and its predicate device. This submission focuses on modifications to three specific applications: Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis. The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to prove the device meets these criteria in the format requested.

The document is a 510(k) summary, which typically provides a high-level overview of substantial equivalence, and not the full study report with detailed performance metrics.

However, based on the available information, I can infer some aspects and highlight what is missing:

Missing Information:

The document lacks the explicit details for most of your requested points, including:

• A clear table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance for the modified spectral analysis features.
• Detailed sample sizes used for the test set (number of patients/cases, number of images).
• Data provenance beyond the mention of "clinical images" and "phantom studies."
• Specific number of experts, their qualifications, and adjudication methods for ground truth.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Specific details of standalone algorithm performance.
• The exact type of ground truth used (e.g., only expert consensus vs. pathology validation).
• Sample size for the training set and how its ground truth was established.

Based on the available text, here's a breakdown of what can be extracted and what remains unknown regarding acceptance criteria and the study:

The submission focuses on modifications to existing features and argues substantial equivalence to a previously cleared device (K192923). The "Testing" section mentions the types of studies conducted but does not provide specific performance results or acceptance criteria in a quantifiable manner.

Acceptance Criteria and Reported Device Performance

Study Details (Inferred and Missing)

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "clinical images" and "phantom studies" were used, but the number of cases, scans, or images for either is not provided.
   • Data Provenance: Not explicitly stated. The document mentions "clinical images," implying real patient data, and "phantom studies." No information about the country of origin, or whether the data was retrospective or prospective, is given.

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

   • Number of Experts: Not explicitly stated. The document mentions "A physician review of clinical images was also performed," but the number of physicians is not specified.
   • Qualifications of Experts: Not explicitly stated. The document only refers to "physician," without specifying their specialty (e.g., radiologist, urologist) or years of experience.

3. Adjudication method for the test set:

   • Adjudication Method: Not explicitly stated. It's unknown if multiple readers independently assessed cases and, if so, how disagreements were resolved (e.g., 2+1, 3+1, or simple majority).

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:

   • MRMC Study: Not explicitly stated. The primary focus of the submission appears to be on maintaining substantial equivalence of modified features, rather than demonstrating human-AI augmentation. The "physician review" mentioned seems to be for validation of the device outputs rather than a comparative study of human performance with and without the device. The device is described as "adjunct."

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

   • Standalone Performance: Not explicitly stated quantitatively. The emphasis is on the software as an "adjunct visualization tool" to assist physicians. While the software has its own "analysis result display" and "image processing," explicit standalone performance metrics (e.g., for segmentation accuracy or classification) are not provided. The statement "meet specifications and perform as intended" refers to the overall system's function.

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

   • Type of Ground Truth: Inferred to be Expert Consensus for clinical images, and known values for phantom studies. The "physician review of clinical images" suggests expert consensus was a component of ground truth determination for clinical data. For "phantom studies," the ground truth would be precisely known physical properties.

7. The sample size for the training set:

   • Training Set Sample Size: Not mentioned. Standard in 510(k) summary documents, information on training set size and specific details of model development are typically proprietary and not included in this high-level summary.

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

   • Training Set Ground Truth Establishment: Not mentioned. As with the training set size, this detail is typically not found in a 510(k) summary.

Summary of what's provided related to "acceptance criteria" and "study":

The document states that "Risk analysis and verification/validation activities conducted through bench testing" and "Additional performance testing, using phantom studies" were performed. It also mentions "A physician review of clinical images" to support a new promotional claim. The overarching conclusion is that "Results of all these studies demonstrate that the features included in this submission meet specifications and perform as intended."

However, the specific quantitative "acceptance criteria" (e.g., a sensitivity threshold of X% or a mean absolute error less than Y) and the detailed results showing how these criteria were met are absent from this 510(k) summary. The document asserts that the modifications to the three spectral analysis applications were evaluated, risks were reduced, and the device performs as intended and is substantially equivalent to its predicate. This assertion implies that internal acceptance criteria were met, but those criteria themselves are not disclosed.

Ask a specific question about this device

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The Spectral Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3 mm with Spectral CT studies acquired on the Canon Medical Systems scanner.

The Spectral Composition Analysis application is intended to assist a physician in visualizing the presence of monosodium urate in anatomical structures. The clinical syndrome of gout is characterized by the presence of monosodium urate crystals in joints or soft tissue.

The Embolization Plan application is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

The Spectral Analysis application is a CT, non-invasive image analysis software package, which may be used to aid in the visualization of anatomical and pathological materials. The software provides quantification of Hounsfield units of iodine attenuation differences and iodine concentration and display by color.

Effective Z and electron density maps may aid in the differentiation of different tissues in the human body.

Vitrea Software Package, VSTP-001A, is an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, SUREVolume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning Tool which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis. The Dual Energy applications are being replaced by Spectral Stone Analysis and Spectral Composition Analysis. These applications, along with Spectral Analysis, utilize DiCOM data acquired by the Spectral Scan System from the scanner, K192828.

The provided document describes the Vitrea Software Package, VSTP-001A, specifically detailing the performance testing for its new "Spectral" features: Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance in narrative form rather than explicit quantitative acceptance criteria. However, based on the descriptions, we can infer the criteria and reported performance for the new Spectral features:

• Effectively generate iodine maps.
• Measure and display iodine concentration.
• Measure Effective Z value.
• Perform subtraction of iodine in Virtual Non-Contrast (VNC) images.
• Generate monochromatic images.
• Produce electron density images. | "This application is comprised of several features which were tested using various phantoms in order to demonstrate their ability to perform their intended functionality. Phantoms with various concentrations of iodine were utilized to asses the effective generation of iodine maps, the measurement and display of iodine concentration, the measurement of the Effective Z value and the subtraction of iodine in virtual non-contrast (VNC) images. Phantom studies were also conducted to evaluate the generation of monochromatic images and the ability to produce electron density images, as derived from measurements of known objects embedded in the phantoms. As determined by the results of each of these tests, Spectral Analysis demonstrates the ability to perform as intended across all evaluated criteria." |

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

The document states that the studies were conducted using phantoms. This suggests:

• Sample Size: Not explicitly stated in terms of number of cases, but "various kidney stones" and "various concentrations of monosodium urate" and "various concentrations of iodine" imply a range of test conditions within the phantom studies. The exact number of phantom configurations or measurements is not provided.
• Data Provenance: The data is based on bench testing with phantoms, rather than human patient data. It is not specified if any real-world patient data was used for testing these specific spectral features. The country of origin for the phantom data is not specified but the submitter is Canon Medical Systems Corporation, Japan.

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

The ground truth for these phantom studies would be the known physical properties of the materials within the phantoms (e.g., actual composition of stones, known concentrations of monosodium urate, known iodine concentrations, known effective Z values, known electron densities). Therefore, human experts were likely not used to establish the ground truth for these specific phantom tests; rather, the phantoms themselves served as the "ground truth" based on their construction and known material properties. No information on human experts establishing ground truth is provided.

4. Adjudication Method for the Test Set

Given that the testing involved phantoms with known physical properties serving as the ground truth, an adjudication method for human interpretation is not applicable. The device's output would be compared directly to the known phantom properties.

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

No, an MRMC comparative effectiveness study was not done for the new Spectral features based on the provided text. The testing described focuses on the standalone performance of the algorithms using phantoms.

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

Yes, standalone (algorithm only) performance testing was done. The descriptions of the studies for Spectral Stone Analysis, Spectral Composition Analysis, and Spectral Analysis clearly indicate that the device's ability to differentiate, extract, display, generate, and measure was evaluated based on phantom studies, without mentioning human readers in the loop for these specific performance evaluations.

7. The Type of Ground Truth Used

The type of ground truth used was known physical properties/composition of phantoms.

• For Spectral Stone Analysis: Known types of kidney stones (uric acid vs. non-uric acid).
• For Spectral Composition Analysis: Known concentrations of monosodium urate in a hand phantom.
• For Spectral Analysis: Known concentrations of iodine, known effective Z values, and known electron densities of objects embedded in phantoms.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set for these algorithms.

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

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

Ask a specific question about this device

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The DE Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3mm with Dual Energy CT studies.

The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.

Embolization Plan is a post processing software that is intended to assist physicians in the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT (INFX-8000 Interventional Family) acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

Vitrea Software Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, Sure Volume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

Here's a breakdown of the acceptance criteria and study information for the Dual Energy Stone Analysis and Embolization Plan applications, based on the provided text.

Dual Energy Stone Analysis

The device is the "Vitrea Software Package: DE Stone Analysis". The study demonstrates substantial equivalence to "Aquilion Dual Energy System Package" (K132813).

1. Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Intended Use: Differentiation between uric acid and non-uric acid stones greater than 3mm.	Subject Device (Vitrea Software Package: DE Stone Analysis): Intended to serve as an adjunct visualization

tool for the differentiation between uric acid and non-uric
acid stones greater than 3mm with Dual Energy CT studies.

Predicate Device (Aquilion Dual Energy System Package): The visualization of the differentiation between uric acid and non-uric acid stones greater than 3mm... is provided with the Dual Energy
system. When used by a qualified physician, a potential application is to determine the course of treatment. |
| Anatomical Region: Whole body. | Both Subject and Predicate devices are indicated for whole body. |
| Feature: Image Processing - Visualization of differentiation between uric acid and non-uric acid stones. | Subject Device: Image Processing - Visualization of the differentiation between uric acid and non-uric acid stones.

Predicate Device: Image Processing - Visualization of the differentiation between Uric Acid and non-uric acid stones. |
| Image data format for image processing: DICOM format of CT image data. | Subject Device: DICOM format of CT image data.

Predicate Device: Original format of CT image data (implicitly compatible with the system generating it). |
| Reconstruction/Viewing: MPR. | Subject Device: MPR.

Predicate Device: MPR / 3D (MPR in DE Stone Analysis). |
| Segmentation: The region included in the range of set CT numbers is extracted. | Subject Device: The region included in the range of set CT numbers is extracted.

Predicate Device: The region included in the range of set CT numbers is extracted. The compositions is extracted based on the composition setting. |
| Overall: Substantially equivalent performance to the predicate device. | Bench studies were conducted using sample data sets from the predicate device verification activities (K131823) and verifying that the outputs for both devices were substantially the same. |

2. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated, but the studies used "sample data sets from the predicate device verification activities (K131823)."
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "predicate device verification activities," which might imply clinical data, but its nature isn't detailed.

3. Number of Experts and Qualifications: Not specified for this particular application.

4. Adjudication Method: Not specified.

5. MRMC Comparative Effectiveness Study: No, the text describes bench testing comparing outputs, not a human reader study.

6. Standalone Performance: Yes, the described "bench testing" compared the outputs of the subject and predicate devices, which implies standalone algorithmic performance.

7. Type of Ground Truth: The ground truth for this comparison was "outputs for both devices were substantially the same" when processed with the same input data. It implies a comparison against the predicate device's output as a form of "ground truth" or reference, rather than an independent gold standard like pathology.

8. Training Set Sample Size: Not specified.

9. Ground Truth for Training Set: Not specified.

Embolization Plan

The device is the "Embolization Plan" software application. The study demonstrates substantial equivalence to "Philips EmboGuide" (K142273).

1. Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Intended Use: Assist physicians in visualization and planning of liver arterial vessels for embolization procedures, using 3D images of CT or Cone Beam CT, and guiding embolization.

(Primary function: determining feeder vessels). | Subject Device (Embolization Plan): ...intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT... planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

Predicate Device (EmboGuide): ...intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. It provides tools to help the user with the analysis of 3D rotational angiography images. Its output is intended as an adjunct means to help with the planning and guidance of the embolization procedure. |
| Anatomical Region: Liver. | Both Subject and Predicate devices are indicated for the liver anatomical region. |
| Input: 3D images (CBCT for predicate). | Subject Device: CT / CBCT.

Predicate Device: CBCT. (Note: The subject device expands input compatibility). |
| Reconstruction/Viewing: MPR / 3D. | Both Subject and Predicate devices support MPR / 3D. |
| Vessel tracking: Automatic/Manual. | Both Subject and Predicate devices support automatic/manual vessel tracking. |
| Distance measurement: Manual. | Both Subject and Predicate devices support manual distance measurement. |
| Overall: Effective in assisting clinicians to identify the required feeder vessels for embolization planning. | The resulting performance data demonstrated that the software was effective in assisting clinicians to identify the required feeder vessels for embolization planning. |

2. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated.
   • Data Provenance: "sample data that was obtained from clinical institutions where local ethical controls were in place." This suggests retrospective clinical data, but the countries of origin are not specified.

3. Number of Experts and Qualifications: Not specified for this particular application.

4. Adjudication Method: "The data was reviewed and verified independently by a test group and a control group." This suggests an independent review, but the specific adjudication rules (e.g., 2+1) are not detailed.

5. MRMC Comparative Effectiveness Study: The study involved a "test group and a control group" reviewing data, and the device's effectiveness in "assisting clinicians" was evaluated. This implies a human-in-the-loop study, but the "effect size of how much human readers improve with AI vs without AI assistance" is not quantified in the provided text. It only states that the software "was effective in assisting clinicians."

6. Standalone Performance: While the software has standalone features, the referenced study explicitly evaluates its performance in "assisting clinicians," indicating a human-in-the-loop context. No purely standalone performance metrics are provided.

7. Type of Ground Truth: The ground truth was implicitly established through review and verification by the "test group and a control group" from clinical institutions. This suggests expert consensus based on clinical data.

8. Training Set Sample Size: Not specified.

9. Ground Truth for Training Set: Not specified.

Ask a specific question about this device

Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchanges of multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications:

The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

Embolization Plan is a post processing software that is intended to assist physicians in the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

The DE Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3mm with Dual Energy CT studies.

The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.

Vitrea Software Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, Sure Volume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

This document is a 510(k) premarket notification for the Vitrea Software Package, VSTP-001A, by Canon Medical Systems Corporation. It describes several applications within the package, but the provided text focuses on the comparative studies for Dual Energy Stone Analysis, Dual Energy Composition Analysis, and Embolization Plan.

Here's an analysis of the acceptance criteria and study information for these specific applications, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the new applications. Instead, it relies on demonstrating substantial equivalence to predicate devices. For the Dual Energy applications, the key acceptance criterion appears to be that the subject device performs in a manner similar to and is intended for the same use as the previously cleared Aquilion Dual Energy Software, and utilizes the same formulas, algorithms, and measurements. For the Embolization Plan, the acceptance criterion is the same intended use as the Philips EmboGuide software and its effectiveness in assisting clinicians to identify the required feeder vessels for embolization planning.

Study Details

The document details separate verification activities for the Dual Energy applications and the Embolization Plan.

Dual Energy Stone Analysis & Dual Energy Composition Analysis

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

   • Sample Size: Not explicitly stated, but described as "sample data sets from the predicate device verification activities (K131823)."
   • Data Provenance: The data came from verification activities for the predicate device. Given the predicate is a Canon Aquilion system, it's likely institutional data, potentially multiple countries, but not specified as retrospective or prospective in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The verification compared outputs to the predicate, implying the predicate's outputs were considered the "ground truth" or reference.

3. Adjudication method: Not applicable/not described. The study was a direct comparison of outputs between the subject and predicate devices.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The study was a bench test verifying output similarity.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The "bench studies" compared outputs of the algorithm to the predicate's outputs, without explicitly mentioning human readers in a comparative evaluation. The "porting of this software" suggests the core algorithms are largely unchanged.

6. The type of ground truth used: The "ground truth" for these applications appears to be the outputs of the predicate device (Aquilion Dual Energy System Package, K132813), which were used as a reference for comparison.

7. The sample size for the training set: Not applicable/not stated. These applications are described as a "porting of application software," implying existing, validated algorithms rather than newly trained AI models requiring a training set in the typical sense.

8. How the ground truth for the training set was established: Not applicable/not stated, as it's not a new AI algorithm requiring a training set described here.

Embolization Plan

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

   • Sample Size: Not explicitly stated as a number, but refers to "sample data that was obtained from clinical institutions."
   • Data Provenance: Obtained from "clinical institutions where local ethical controls were in place." This suggests real-world patient data, but whether it was retrospective or prospective is not specified. Country of origin not specified.

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

   • Number of Experts: The data "was reviewed and verified independently by a test group and a control group." The size of these groups is not specified.
   • Qualifications of Experts: Not explicitly stated, but implied to be "clinicians" capable of identifying "required feeder vessels for embolization planning."

3. Adjudication method: Not explicitly described. The text mentions "reviewed and verified independently by a test group and a control group," which could imply some form of consensus or comparison, but details are absent.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not explicitly an MRMC comparative effectiveness study in the typical sense of comparing human readers with and without AI assistance. It refers to data being "reviewed and verified independently by a test group and a control group," which might be a form of clinical evaluation but isn't detailed enough to confirm an MRMC with effect size reporting.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The reported performance is about "assisting clinicians," implying a human-in-the-loop context.

6. The type of ground truth used: The ground truth for the effectiveness of identifying feeder vessels would have been established by the "test group and a control group" of clinicians, based on their expert judgment and potentially clinical outcomes (though outcomes data is not stated). This points towards "expert consensus" or "expert judgment" as the basis for the ground truth.

7. The sample size for the training set: Not applicable/not stated. This application is described as software that "assists physicians" and "provides tools to assist the user," implying a rule-based or conventional image processing approach rather than a machine learning model requiring a distinct training set.

8. How the ground truth for the training set was established: Not applicable/not stated.

Ask a specific question about this device

Vitrea Software Toshiba Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

Vitrea Software Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Toshiba Package, VSTP-001A, currently includes seven post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking and Ultrasound Applications Package, which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

The provided text describes a 510(k) submission for the Vitrea Software Package, VSTP-001A. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond general statements about equivalence to a predicate device through "bench testing" and "regression testing".

The document states:

• "Risk analysis and regression testing was conducted through bench testing are included in this submission which demonstrates that the requirements for the applications have been met."
• "Bench studies were conducted using sample data sets from the predicate device verification activities (K173090) and verifying that the outputs for both devices were substantially the same."
• "Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device."

This indicates that the primary method of demonstrating performance was through comparative bench testing against a predicate device, focusing on "substantially the same" outputs. It does not provide the quantitative details typically associated with acceptance criteria tables and clinical/algorithm performance studies as outlined in your request.

Therefore, I cannot populate the requested tables and specific study details.

Here's why and what's missing, based on your request:
1. A table of acceptance criteria and the reported device performance:
* Not Available: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, measurement accuracy thresholds) or corresponding reported performance metrics for any specific application within the Vitrea Software Package. It only mentions that "requirements...have been met" through bench testing.

2. Sample size used for the test set and the data provenance:
* Not Available: The document mentions "sample data sets from the predicate device verification activities (K173090)" were used for bench testing. It does not specify the sample size, country of origin, or if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable/Not Available: The testing described is "bench testing" comparing outputs to a predicate device. This implies a technical verification of outputs rather than an expert-driven "ground truth" establishment for diagnostic accuracy, as would be the case for an AI-driven diagnostic aid. No experts are mentioned in the context of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not Applicable/Not Available: Adjudication methods are typically used when multiple human readers interpret data to establish a consensus ground truth. This type of study is not described.

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: The document does not describe an MRMC study. The device is a "post-processing application" to "assist physicians in performing specialized measurements and analysis," but no study on human performance improvement with or without the device is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes (partially, but no detailed metrics): The "bench testing" implicitly acts as a "standalone" performance check in that it verifies the software's outputs against known outputs from the predicate device. However, no specific standalone performance metrics (like accuracy for a classification task) are provided, only that the outputs were "substantially the same."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated/Implied "Predicate Device Outputs": The "ground truth" for the bench testing appears to be the outputs generated by the predicate device (K173090). This is a technical comparison rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:
* Not Applicable/Not Available: This device is described as software for "post-processing" and "analysis" that applies "formulas, algorithms and measurements" similar to a predicate. There is no mention of machine learning or deep learning, and therefore no "training set" in the sense of an ML model.

9. How the ground truth for the training set was established:
* Not Applicable/Not Available: As no training set for an ML model is mentioned, this question is not applicable.

In conclusion, the 510(k) summary focuses on demonstrating substantial equivalence primarily through technical bench testing against a predicate device, and it does not provide the detailed performance study results that would typically be associated with AI-driven devices requiring specific quantitative acceptance criteria and clinical validation studies.

Ask a specific question about this device