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This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve has the capability to provide volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

Aquilion Serve (TSX-307A/1) V1.3 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, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

The provided text is a 510(k) summary for the Aquilion Serve (TSX-307A/1) V1.3, a Computed Tomography X-ray System. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or details of a study that proves the device meets those criteria in the format requested.

The document primarily focuses on explaining modifications from a prior version of the device (V1.2 with AiCE-i) and comparing technological characteristics. It mentions "Performance Testing - Bench" for SilverBeam Image Quality Evaluation and SilverBeam Dose Reduction, and "Workflow Evaluation," but these are described as general assessments rather than detailed studies with quantitative acceptance criteria and results. Furthermore, there is no mention of an MRMC study, expert ground truth establishment with multiple readers, or detailed sample sizes for training/test sets as typically required for AI/algorithm performance studies in the context of device clearance.

Therefore, I cannot provide the requested information from the given text. The information outlined in your request (specifically points 1-9 regarding acceptance criteria, study design, expert involvement, and ground truth) is not present in this 510(k) summary. This document primarily focuses on hardware and software feature additions (Dynamic scan mode, Exposure reduction mode, Dual Energy scanning, Extended field of view) and their safety and equivalence to an existing cleared device, rather than detailed performance metrics of an AI algorithm like AiCE that would be evaluated with clinical accuracy studies.

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This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Exceed LB has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i (Advanced intelligent Clear-IQ Engineintegrated) 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, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

The provided document is a 510(k) summary for the Canon Medical Systems Corporation's Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i. It discusses the device's substantial equivalence to a predicate device, focusing on an expanded clinical use for the AiCE (Advanced Intelligent Clear-IQ Engine) feature, specifically to include cardiac applications.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating that the subject device performs similarly to or better than the predicate device. The acceptance criteria are implicitly tied to maintaining or improving upon the predicate's performance, particularly in image quality and the diagnostic utility of AiCE-reconstructed images.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for the phantom studies (e.g., number of scans, repetitions). For the human review of cardiac images, it states "Representative cardiac diagnostic images," but does not provide a numerical count.
• Data Provenance: The document implies the studies were conducted internally by Canon Medical Systems, given the context of a 510(k) submission. No specific country of origin is mentioned for the data, but the submitter is based in Japan (Canon Medical Systems Corporation, Shimoishigami Otawara-Shi, Tochigi-ken, Japan). The studies are inherently "prospective" in the context of validating the device for its submission.

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

• Number of Experts: For the evaluation of cardiac diagnostic images, only one expert is explicitly mentioned: "reviewed by an American Board Certified Radiologist."
• Qualifications of Experts: The expert was an "American Board Certified Radiologist." No specific tenure or experience level is mentioned beyond being Board Certified.

4. Adjudication Method for the Test Set

• For the phantom studies, no human adjudication is mentioned, as the results are based on objective image quality metrics.
• For the cardiac diagnostic image review, with only one radiologist reviewing, there was no adjudication method described (e.g., no 2+1 or 3+1 consensus process). The assessment was a single expert's confirmation.

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

• No, an MRMC comparative effectiveness study was not explicitly done or described. The document focuses on technical bench testing (phantom studies) and a single expert's review of "representative cardiac diagnostic images" to confirm diagnostic quality. There is no mention of human readers improving with or without AI assistance, or any comparative analysis of human performance. The AiCE itself is a noise reduction algorithm, not a diagnostic AI intended to assist human interpretation directly in terms of detection or diagnosis.

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

• Yes, in essence, standalone performance (algorithm only) was assessed for the AiCE feature. The "Image Quality Evaluation" using phantoms measured the intrinsic performance of the AiCE algorithm (and the overall system) in terms of various image quality metrics (CNR, CT Number Accuracy, etc.). These are objective measurements of the algorithm's output quality, independent of human interpretation.
• The "Dual Energy" phantom studies also represent a form of standalone performance assessment for those features of the system.

7. The Type of Ground Truth Used

• Physiological Phantom Measurements: For the bulk of the image quality and dual-energy assessments, the ground truth was established by known physical properties of phantoms. These phantoms are designed with specific, measurable characteristics (e.g., known electron densities, accurate CT numbers, specific contrast elements) that serve as the "true" values against which the device's measurements are compared.
• Expert Consensus (single expert): For the "representative cardiac diagnostic images," the ground truth regarding "diagnostic quality" relied on the opinion/assessment of a single American Board Certified Radiologist. While not a "consensus" in the multi-reader sense, this expert's judgment served as the ground truth for diagnostic utility in this specific clinical application.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set for the AiCE Deep Convolutional Network. Information on training data is typically proprietary and not included in 510(k) summaries unless specifically relevant to substantial equivalence arguments.

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

• The document does not provide information on how the ground truth was established for the training set of the AiCE Deep Convolutional Network. This information is usually part of the internal development and validation of the AI algorithm itself, which predates the specific 510(k) submission for this device modification.

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uCT ATLAS is a computed tomography x-ray system, which is intended to produce cross-sectional images of the whole body by computer reconstruction of x-ray transmission data taken at different angles and planes. uCT ATLAS is applicable to head, whole body, cardiac, and vascular x-ray Computed Tomography.

uCT ATLAS has the capability to image a whole organ in a single rotation. Organs include, but not limited to head, heart, liver, kidney, pancreas, joints, etc.

uCT ATLAS is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

u WS-CT-Dual Energy Analysis software uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The proposed device uCT ATLAS with uWS-CT-Dual Energy Analysis includes image acquisition hardware, image acquisition, reconstruction and dual energy analysis software, and associated accessories.

The uCT ATLAS is a multi-slice computed tomography scanner that features the following specification and technologies.

• 160 mm z-coverage in a single axial exposure with a 320-row 0.5 mm-slice Z-• Detector
• . 0.25 s rotation speed for high temporal resolution, and maximum 440 mm/s fast volumetric scanning capability
• . 82 cm bore size, 318 kg (700 lbs) maximum table load capacity allows flexible positioning and access for all patients
• . The new generation reconstruction method. Deep IR (also named AIIR), which combines the model-based iterative reconstruction and deep learning technology together, in order to reduce image noise and artifacts, while at the same time improving low contrast detectability and spatial resolution
• . The uAI Vision patient positioning assistance
  Built upon these technologies, the uCT ATLAS is designed to use less radiation dose than the previous generation product while maintaining the same diagnostic level of image quality. Further, the whole organ coverage and fast scanning capability benefits the clinical applications, especially for cardiac imaging, dynamic whole organ imaging and fast body and vascular imaging.

The uWS-CT-Dual Energy Analysis is a software package that uses UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information.

The provided text does not contain information about specific acceptance criteria or a detailed study proving that a device meets those criteria. The document is a 510(k) premarket notification summary for the uCT ATLAS with uWS-CT-Dual Energy Analysis system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria.

While the document mentions "Performance Verification" and "Clinical Image Evaluation of applications," and states that "The testing results show that all the software specifications have met the acceptance criteria," it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for test sets.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specifics about the type of ground truth used or how ground truth for training sets was established.

The document states that "No Clinical Study is included in this submission," which further indicates that the detailed information you're requesting regarding clinical performance studies isn't present in this specific FDA submission summary.

The closest information available is:

• Non-Clinical Testing: Includes dosimetry and image performance tests, and conformance to various electrical safety, EMC, and product particular standards (e.g., NEMA XR 25-2019, IEC 61223-3-5). The acceptance criteria for these would be compliance with the specified standards, but the specific performance values are not detailed.
• Software Verification and Validation: Mentions that "all the software specifications have met the acceptance criteria," but does not list those criteria or performance results.

In summary, the provided document focuses on regulatory clearance through substantial equivalence, indicating that the device has similar performance and safety as legally marketed predicate devices. It does not contain the detailed performance study information you are seeking.

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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.

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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 Neural Network methods for abdomen, pelvis, inner ear and extremities applications.

The Spectral Imaging System 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.

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

Aquilion ONE (TSX-306A/3) V10.0 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.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list numerical "acceptance criteria" in the format of a table with pass/fail thresholds. Instead, it describes various tests and claims that demonstrate substantial equivalence to previously cleared devices. The performance is reported in terms of qualitative assessments (e.g., "diagnostic quality," "substantially equivalent") and quantitative improvements (e.g., "dose reduction," "improvement in low contrast detectability," "noise reduction").

Here's an interpretation of the implied acceptance criteria and reported performance:

• More similar to high dose FBP (compared to FIRST);
• More similar to FBP (compared to FIRST);
• Improved (compared to FIRST);
• More natural (compared to FIRST). | AiCE noise appearance/texture:
• More similar to high dose filtered backprojection (compared to FIRST);
• More similar to filtered backprojection (compared to FIRST);
• Improved (compared to FIRST);
• More natural (compared to FIRST). |
  | Clinical Image Quality | AiCE images for abdomen/pelvis, brain, inner ear, and extremity applications are of diagnostic quality. | Representative abdomen/pelvis, brain, inner ear and extremity AiCE images were confirmed to be of diagnostic quality by an American Board Certified Radiologist. |

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

• Spectral Imaging Performance Testing - Bench: The sample size for phantoms used in bench testing is not specified beyond "various phantoms" and "Catphan and Body Phantom." Data provenance is laboratory bench testing.
• Spectral Imaging Performance Testing - Clinical Images: The sample size is not specified beyond "Representative abdomen/pelvis, lung, and extremity Spectral Images." The data provenance of these clinical images (country of origin, retrospective/prospective) is not specified in the provided text.
• Non-Spectral Imaging and AiCE Performance Testing - Bench: The sample size for phantoms used in bench testing is not specified beyond "various phantoms." Data provenance is laboratory bench testing.
• AiCE Imaging Performance Testing - Clinical Images: The sample size is not specified beyond "Representative abdomen/pelvis, brain, inner ear and extremity AiCE images." The data provenance of these clinical images (country of origin, retrospective/prospective) is not specified in the provided text.

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

• For both Spectral Imaging Clinical Images and AiCE Clinical Images: "an American Board Certified Radiologist" was used. This indicates one expert. The specific years of experience are not mentioned, but "American Board Certified" signifies a high level of qualification.

4. Adjudication Method for the Test Set

• For both Spectral Imaging Clinical Images and AiCE Clinical Images, only one expert (an American Board Certified Radiologist) reviewed the images. Therefore, there was no adjudication method between multiple experts employed for these clinical image quality assessments. The phrase "it was confirmed" implies a singular decision.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a MRMC comparative effectiveness study was not explicitly mentioned in the provided text for evaluating human reader improvement with AI assistance. The clinical image reviews were done by a single radiologist to confirm "diagnostic quality" of the AI-processed images, not to compare human reader performance with and without AI. The quantitative performance (dose reduction, LCD improvement, noise reduction) was assessed via model observer evaluation or phantom studies.

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

• Yes, extensive standalone performance testing was done for both Spectral Imaging and AiCE.
  • Spectral Imaging: Bench testing utilizing phantoms assessed various image quality metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD) to demonstrate substantial equivalence to the predicate. Other phantom studies supported claims of beam hardening artifact reduction and iodine concentration correlation.
  • AiCE: Bench testing utilizing phantoms assessed similar image quality metrics and pediatric phantom/protocol performance, demonstrating substantial equivalence. A model observer evaluation was specifically mentioned for quantitative assessments of dose reduction, LCD improvement, and noise reduction compared to FBP and AIDR 3D, which is a standalone algorithm-only performance assessment. Other phantom studies supported claims regarding artifact appearance, spatial resolution, and noise appearance/texture.

7. The Type of Ground Truth Used

• For Bench Testing (Spectral and AiCE): The ground truth was based on physical phantom measurements and known properties/compositions of the phantoms. For example, known concentrations of materials for iodine correlation, or predefined structures for MTF and LCD assessments.
• For Clinical Image Reviews (Spectral and AiCE): The ground truth was expert consensus (single expert), specifically the judgment of an American Board Certified Radiologist that the images were of "diagnostic quality." This is a form of expert opinion or interpretation.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set for either AiCE (Deep Convolutional Neural Network) or FIRST (Iterative Reconstruction Algorithm). It only mentions that AiCE employs "Deep Convolutional Neural Network methods."

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

• The document does not provide details on how the ground truth for the training set was established. It mentions the use of "Deep Convolutional Neural Network methods" for AiCE, which implies a supervised learning approach requiring labeled training data, but the specifics of that labeling process or who performed it are omitted.

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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.

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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.

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This device is indicated to acquire and display cross sectional volumes of the whole body, to include 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/hardware, of the whole organ by a trained and qualified physician.

Aquilion ONE (TSX-305A/3) V7.3 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 Toshiba CT systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquilion ONE (TSX-305A/3) V7.3:

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary for a premarket notification for a Computed Tomography X-ray System. It is not a clinical study report with specific acceptance criteria directly tied to a diagnostic performance metric (like sensitivity or specificity) of a disease-detecting AI algorithm. Instead, it demonstrates substantial equivalence to a predicate device, focusing on technical specifications and image quality for general diagnostic use.

Therefore, the "acceptance criteria" here relate to demonstrating that the new device performs acceptably for its intended use and is equivalent to the predicate. The "performance" is primarily a comparison of technical specifications and image quality metrics against the predicate.

• View rate: Maximum 2910 views/s (same)
• Detector: 896 channels x 320 rows (same)
• Pitch factor: Range 0.555 to 1.575 / 0.555 to 1.5 (very similar)
• FOV: 240/320/500mm / 180/240/320/400/500mm (subject has slightly reduced range, but still within typical diagnostic needs)
• Metal artifact reduction: SEMAR (Volume, Helical, ECG gated) / SEMAR (Volume, Helical) (subject has added ECG gated capability)
• Gantry opening size: 780 mm (same)
• All previously cleared software options are listed as "no change" in functionality, with some having "workflow improvements" (e.g., Lung Volume Analysis, surESubtraction Lung, MyoPerfusion, Dual Energy System Package, 4D Airways Analysis) which are enhancements rather than regressions.

Differences (addressed through testing or not raising new concerns):

• Gantry Rotation Speed: 0.35s (Optional max 0.275s) for subject vs. 0.275s (Standard or optional) for predicate. This indicates a minor hardware difference, likely addressed by showing image quality is maintained.
• Wedge filter types: Two types for subject vs. Three for predicate. This is a minor design change.
• X-ray tube voltage/current: Max 72kW (Optional Max 90kW) for subject vs. Max 90kW (for one model) or Max 72kW (for others) for predicate. Comparable.
• Image reconstruction time: Up to 80 images/s for subject vs. Up to 50 images/s for predicate. Improvement in subject device.
• Helical reconstruction method: 20 rows or more: TCOT+ for subject vs. 16 rows or more: TCOT+ for predicate. Improvement in subject device (more rows).
• Patient Couch Type and related dimensions/weights: Various configurations/differences between subject and predicate models, indicating design variations but within expected functional range.
• Gantry tilt angle: ±30° for subject vs. ±22° for predicate. Improvement in subject device.
• Minimum area for installation: Smaller for subject (27m² vs 37.2m²). Improvement in subject device.
• Area finder: Optional for subject vs. NA for predicate. New feature on subject device. |
  | Image Quality | Image quality metrics (spatial resolution, CT number magnitude/uniformity, noise properties, low contrast detectability/CNR performance) should meet established specifications and be comparable to the predicate device. Images obtained should be of diagnostic quality. | CT image quality metrics performed using phantoms demonstrated that the subject device is substantially equivalent to the predicate device with regard to: spatial resolution, CT number magnitude/uniformity, noise properties, and low contrast detectability/CNR performance. Representative diagnostic images (head, chest, abdomen/pelvis, extremity, cardiac) were also reviewed and demonstrated diagnostic quality. |
  | Safety and Standards Compliance | The device must be designed and manufactured under Quality System Regulations (21 CFR 820, ISO 13485) and conform to applicable performance standards for ionizing radiation-emitting products (21 CFR, Subchapter J, Part 1020). It must also comply with various IEC, NEMA, and other relevant standards. | The device is designed and manufactured under QSR and ISO 13485. It conforms to applicable performance standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] and numerous international standards including IEC60601-1 series, IEC60601-2 series, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. |
  | Software Validation | Software documentation must comply with FDA guidance for a Moderate Level of Concern, and validation testing should be successfully completed. | Software Documentation for a Moderate Level of Concern was included. Successful completion of software validation is cited in the conclusion. |
  | Risk Management | Risk analysis should be conducted. | Risk analysis was conducted. |

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

• Test Set Description: The "test set" for this submission primarily consists of:
  • Phantoms: Used for evaluating CT image quality metrics (spatial resolution, CT number, noise, low contrast detectability). The number and specific types of phantoms are not explicitly stated but are typically standard phantoms used in CT performance testing.
  • Representative Diagnostic Images: Clinical images covering various body regions (head, chest, abdomen/pelvis, extremity, cardiac). The number of cases/patients is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the diagnostic images. Given Toshiba Medical Systems Corporation is based in Japan and Toshiba America Medical Systems, Inc. is in the US, the data could originate from either region or a combination. The document also does not specify if the data was retrospective or prospective. However, for a 510(k) clearance based on substantial equivalence, particularly for a hardware/software update to a CT scanner, diagnostic images are often retrospectively collected or acquired as part of internal validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: One (1) expert is explicitly mentioned.
• Qualifications of Experts: An "American Board Certified Radiologist." No specific years of experience are stated. This expert reviewed the representative diagnostic images to confirm diagnostic quality.

4. Adjudication Method for the Test Set:

• The document describes a single American Board Certified Radiologist reviewing images to confirm diagnostic quality. This indicates no formal adjudication method involving multiple readers (like 2+1 or 3+1) was used for this specific part of the evaluation. The assessment of image quality from phantoms would not typically involve expert adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a general-purpose CT scanner system, not an AI-specific diagnostic tool that assists human readers. Therefore, there is no mention of an effect size for human reader improvement with or without AI assistance.

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

• No, a standalone performance study in the context of an AI algorithm was not done. The Aquilion ONE (TSX-305A/3) V7.3 is a complete CT system where the "algorithm" refers to the image reconstruction and processing capabilities, which are inherent to the device's function. The study validates the overall system's ability to produce diagnostic images, not a separate AI algorithm's diagnostic accuracy. The performance is assessed on the system output.

7. The Type of Ground Truth Used:

• For the phantom studies, the "ground truth" is typically known physical properties of the phantoms (e.g., known dimensions, densities, contrast levels).
• For the representative diagnostic images, the "ground truth" for confirming "diagnostic quality" is based on the expert opinion/consensus of an American Board Certified Radiologist. This is a form of expert consensus, albeit from a single expert in this stated context. There is no mention of pathology or outcomes data being used as ground truth for this submission.

8. The Sample Size for the Training Set:

• The document does not specify a separate "training set" sample size. This submission is for a medical imaging device (CT scanner) rather than a deep learning AI algorithm that undergoes distinct training. The underlying algorithms for image reconstruction and processing (e.g., TCOT+, SEMAR) are developed and refined through engineering and iterative testing, but not typically in the same "training set" paradigm as AI for diagnostic interpretation. The software validation is mentioned, which refers to standard software development lifecycle testing.

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

• As a "training set" in the context of AI development is not explicitly mentioned as relevant to this submission, the establishment of ground truth for a training set is not applicable/described. The "ground truth" during the development of a CT scanner's image reconstruction algorithms would typically involve engineering specifications, physical models, and potentially early clinical data used for empirical tuning and validation, but not a formally labeled training set in the AI sense.

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This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion Prime has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

The Aquilion PRIME TSX-303A/A and /B, v6.00 are 80-row CT Systems and the TSX-303A/F, v6.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

This document is a 510(k) premarket notification for a Computed Tomography (CT) system, the Aquilion PRIME, v6.00. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for a novel AI-powered diagnostic device.

Therefore, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is framed within the context of demonstrating equivalence and safety/effectiveness for a hardware/software update to an existing CT system, rather than a standalone performance study with clinical endpoints.

Here's an attempt to extract the closest available information based on your request, acknowledging that the format and detail for a conventional "acceptance criteria" study are not fully present in this type of submission.

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

Based on the document, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and meeting regulatory standards for CT systems. The "reported device performance" is described in terms of improved imaging properties and diagnostic quality.

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

• Test Set Sample Size: Not explicitly stated as a number of patients or cases. The document mentions "representative diagnostic images" but does not quantify them.
• Data Provenance: Not specified. It's likely that the "representative clinical images" were obtained during internal testing or pilot sites, but no details on country or retrospective/prospective nature are provided.

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

• Number of Experts: "an American Board Certified Radiologist" (singular).
• Qualifications of Experts: "American Board Certified Radiologist." No specific experience level (e.g., 10 years) is mentioned.

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

• Adjudication Method: "Reviewed by an American Board Certified Radiologist." This implies a single reader review, so no adjudication method (like 2+1 or 3+1) was used.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a CT system itself, not an AI-assisted diagnostic tool designed to improve human reader performance. Its purpose is to demonstrate the fundamental image quality and safety of the CT scanner.

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

• This is not applicable in the context of this submission. The device is a CT scanner, which inherently produces images for human interpretation. The "software options" mentioned (SEMAR, SURESubtraction Ortho, Dual Energy System Package) are image processing algorithms that enhance the raw CT data, but the "performance" as described (image quality metrics, diagnostic quality) still relates to the final image presented for a human in the loop. There is no "algorithm only" performance study in the sense of an automated diagnostic algorithm.

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

• The "ground truth" for evaluating image quality appears to be based on:
  • Phantom measurements: For spatial resolution, CT number, contrast-to-noise ratio, and uniformity performance.
  • Expert opinion: The "American Board Certified Radiologist" reviewing representative diagnostic images for diagnostic quality. This functions as the human expert assessment indicating the images are fit for interpretation.

8. The sample size for the training set

• Not applicable/provided. This document describes a new version of an existing CT scanner, not a novel machine learning algorithm that requires a separate training set. The "software options" mentioned were previously cleared and their development (including any training data if applicable) would have been part of their original 510(k) submissions.

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

• Not applicable. See point 8.

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