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The Diagnostic Ultrasound System Viamo c100 Model TUS-VC100 is indication of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs (breast, transvaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (adult, pediatric), peripheral vascular, musculo-skeletal (conventional, superficial), and urology.

The Viamo c100 TUS-VC100 Diagnostic Ultrasound System is an integrated, preprogrammed, color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system utilizes the ultrasound echo characteristics, transmits ultrasonic energy into patient body, sweeps in a certain direction, processes the signals according to the delay time and the echo strength, and images the organs by using the electronic circuits and backend controller to process, then analyzes the distance and the status of organs; and at the same time, this system utilizes Doppler and autocorrelation technology to image the blood flow and add the color-coding information to the grayscale image of B mode, then displays the image in real time. The probes provided with this system are electrical-acoustical-electrical transducers. The probes firstly convert the electric excitation signal to the acoustic signal and transmit the signal into the patient body, then converts the echo signals from the patient body to electric signal. The echo signal is processed and converted by DSC to image signal to output to the LCD display. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes and 3D/4D.

The provided document is a 510(k) premarket notification for the Toshiba Medical Systems Corporation Viamo c100 TUS-VC100 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, the document explicitly states, "No clinical testing was required."

However, it does detail non-clinical tests conducted to ensure safety and effectiveness.

Here's a breakdown of the information requested, based on the provided document:

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

Since no clinical studies were performed to establish performance metrics against specific acceptance criteria for diagnostic accuracy, a direct table of clinical acceptance criteria and reported device performance cannot be generated.

However, the non-clinical acceptance criteria are based on conformance to established medical device safety standards. The reported performance is that the device was found to conform to these standards.

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

• No clinical test set was used. The submission states "No clinical testing was required." The evaluation was based on non-clinical tests demonstrating conformance to safety standards.

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)

• Not applicable. Since no clinical testing was performed, there was no need for experts to establish ground truth for a test set.

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

• Not applicable. No clinical test set was used, therefore no adjudication method was employed.

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

• Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This is a hardware-based diagnostic ultrasound system, not an algorithm being tested for standalone performance.

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

• Ground truth (for non-clinical tests): The "ground truth" for the non-clinical tests was the established requirements and specifications within the referenced international and national safety standards (IEC, NEMA, ISO). Conformance to these standards served as the "ground truth" for demonstrating the device's safety and fundamental performance characteristics.

8. The sample size for the training set

• Not applicable. This document pertains to regulatory clearance for a diagnostic ultrasound system, not an AI/machine learning model that would require a training set.

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

• Not applicable. As no training set was used (see point 8), there was no ground truth to establish for it.

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

FIRST 3.0 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.

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is an ultra-high resolution whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7-MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 3.0, intended to reduce exposure dose while maintaining and/or improving image quality.

The provided document describes the Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0, a Computed Tomography (CT) system, and its substantial equivalence to a predicate device. The performance validation focuses heavily on image quality metrics and spatial resolution, particularly for the new HR (High Resolution) and SHR (Super High Resolution) modes and the FIRST 3.0 iterative reconstruction algorithm.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with corresponding performance metrics like a typical study design. Instead, it describes various tests and their outcomes, often in qualitative terms comparing the new device to a predicate or describing improvements. However, we can infer some criteria and their met outcomes:

• The HR and SHR modes "yield improved high contrast spatial resolution with some tradeoff in noise and LCD relative to NR mode."
• The FIRST algorithm "demonstrates equivalent or improved image quality relative to FBP for all modes." |
  | High Contrast Spatial Resolution | Achieve a specific high contrast spatial resolution, particularly with HR mode and FC90 reconstruction. | - A high contrast spatial resolution claim of "up to 46.1 lp/cm based upon the 2% of the MTF of images of a wire test object acquired in HR mode, under the axial scan mode and reconstructed with FC90" is supported initially.
• Later, it's stated that "a high contrast spatial resolution claim of up to 49.5 lp/cm, based upon the 2% of the MTF of images of a wire test object acquired in HR mode and reconstructed with FC90, is supported." This suggests an even better performance than initially stated, or a refinement of the measurement. |
  | Low Contrast Detectability (LCD) and Dose | Maintain equivalent or reasonable LCD, and ideally demonstrate dose reduction capabilities with FIRST. | - HR and SHR modes "may result in equivalent or a modest increase in X-ray dose as compared to scanning in normal resolution mode (NR)."
• "As demonstrated by the performance of FIRST at reduced mA values for standard deviation, MTF, and visual LCD as compared to FBP at higher mA values a qualitative claim of Dose Reduction with FIRST is supported."
• A study on Head and Body MITA-FDA LCD phantoms established baseline LCD (AUC) values and indicated potential trade-offs. |
  | Size Discrimination | Demonstrate improved size discrimination. | - A 50% improvement in size discrimination was observed with High Resolution mode compared to Normal Resolution mode at the same dose, using Catphan 10HU contrast rods (4-9mm diameter) in a model observer study. |
  | Diagnostic Quality | Produce images of diagnostic quality across various anatomical regions. | - "Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended." |
  | Substantial Equivalence | Demonstrate substantial equivalence to the predicate device. | - "The Aquilion Precision in NR mode is substantially equivalent to the predicate device."
• "NR mode and predicate device images were substantially equivalent." |

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

The document does not explicitly state sample sizes for all tests.

• Spatial Resolution Confirmation: "the MTF results of seven Aquilion Precision systems" were measured. This is a sample size of 7 systems, likely involving phantom data.
• Low Contrast Detectability: "Head and Body MITA-FDA LCD phantoms" were utilized. The number of phantoms or scans is not specified.
• Size Discrimination Performance: "Catphan 10HU contrast rods, 4-9mm in diameter" were used. The number of scans or virtual phantoms is not specified.
• Cadaver and Cardiac Stent Images: "cadaver and cardiac stent images" were provided. The number of cadavers or stents is not specified.
• Diagnostic Quality Images: "Representative diagnostic images... including head, chest, abdomen/pelvis, extremity and cardiac exams" were obtained. The number of cases is not specified.

Data Provenance: Primarily phantom data and some cadaver/stent images appear to be used for the technical performance assessments. The diagnostic quality images were "obtained using the subject device," implying prospective acquisition for the purpose of this submission rather than retrospective data. The location of data acquisition (country of origin) is not specified, but the submission is by Toshiba Medical Systems Corporation, Japan, and Toshiba America Medical Systems, Inc., USA.

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

• Diagnostic Quality Images: "Representative diagnostic images, reviewed by an American Board Certified Radiologist."

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

• For the phantom-based studies (spatial resolution, LCD, size discrimination), the "ground truth" is typically inherent in the phantom design and physical measurements, rather than established by human experts.

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

• For the diagnostic quality image review by "an American Board Certified Radiologist," no adjudication method is mentioned, implying it was a single reader assessment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study involving human readers and AI assistance (FIRST 3.0) is described. The studies primarily focus on the objective image quality metrics of the device itself and its reconstruction algorithms. The "model observer study" for size discrimination is a computational model, not human readers.

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

• Yes, the majority of the image quality evaluations (CT number accuracy, contrast-to-noise ratio, uniformity, slice sensitivity profile, MTF, LCD, etc.) of the FIRST 3.0 algorithm and the new acquisition modes (HR, SHR) are "standalone" performance evaluations. They assess the inherent image characteristics produced by the system and its algorithms using phantoms, independent of a human observer's interpretation in a clinical context.

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

• Phantom-based studies: The ground truth is the known properties of the phantoms (e.g., known dimensions of rods, known contrast differences, known noise levels).
• Diagnostic Quality Images: The ground truth for this qualitative assessment is the subjective expert opinion of "an American Board Certified Radiologist" that the images are of "diagnostic quality." This is a form of expert opinion, but not "consensus" as only one expert is mentioned.
• No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set:

The document does not provide any information about the training set or its sample size. This is typical for submissions focused on the hardware and reconstruction algorithms of a CT scanner, where the "training" (if applicable for AI components) would be part of the algorithm development process, not usually detailed in a 510(k) summary for hardware clearance unless the AI itself is the primary new component. FIRST 3.0 is an iterative reconstruction algorithm, which generally relies on mathematical models and image processing, not necessarily on "training data" in the machine learning sense to learn to identify specific pathologies.

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

Not applicable, as no information on a training set or its ground truth establishment is provided.

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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 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.

Vitrea Software Toshiba 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 three post processing applications, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, and MR Coronary Tracking which use brain and cardiac image data, obtained from CT/XA/MR systems, to assist physicians in performing specialized measurements and analysis.

The provided document describes the Vitrea Software Toshiba Package, VSTP-001A, which includes several applications. The information regarding acceptance criteria and studies is provided for the new applications being submitted: SUREVolume Synthesis, US Cardiac Fusion, and Angio Viewer.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• SUREVolume Synthesis & US Cardiac Fusion:
  • Sample size: Not explicitly stated as a number of cases or images. The text mentions "various combinations of data sets" for SUREVolume Synthesis and "CCTA images and 3D Wall motion tracking images" for US Cardiac Fusion.
  • Data provenance: Not explicitly stated (e.g., country of origin). The studies were described as "clinical evaluations conducted at clinical sites" for both. The text does not specify retrospective or prospective.
• Angio Viewer:
  • Sample size: Not explicitly stated. The text mentions "repeated measurements."
  • Data provenance: Not explicitly stated. The evaluation was "conducted head on against the predicate device at the design site." Implies retrospective use of existing data for comparison.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking:
  • Sample size: Not explicitly stated. The text mentions "numerical phantoms."
  • Data provenance: Not explicitly stated. These were "bench studies."

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

• SUREVolume Synthesis & US Cardiac Fusion: The text states, "In both studies users of varying levels of experience reviewed all images and performed manual alignments as required." It does not specify the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience").
• Angio Viewer, CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: Not specified for these applications.

4. Adjudication method for the test set

• SUREVolume Synthesis & US Cardiac Fusion: For these clinical evaluations, "users of varying levels of experience" performed manual alignments when automatic alignment was not successful. This implies that the initial "ground truth" for success/failure of automatic alignment might have been based on their interpretation, and their subsequent manual alignments formed a manual "ground truth" for comparison. An explicit adjudication method like 2+1 or 3+1 is not mentioned.
• Angio Viewer: The evaluation involved "repeated measurements" against a predicate device. This suggests a direct comparison rather than an adjudication process by multiple experts.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: These involved bench studies with numerical phantoms. Adjudication by experts is not applicable here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study, evaluating human reader improvement with or without AI (or in this case, the software applications), is described in the provided text. The studies primarily focused on the performance of the software applications themselves, or direct comparison against a predicate device, rather than a reader study.

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

• SUREVolume Synthesis & US Cardiac Fusion: The studies mention "automatic alignment success" which represents a standalone algorithm performance metric. However, it also clarifies that "users of varying levels of experience" performed manual alignments when automatic alignment failed, indicating that human-in-the-loop performance (manual adjustment) was also evaluated as a fallback.
• Angio Viewer: The "bench testing at the design site against its predicate device" and replicating measurements implies a standalone comparison of the software's measurement capabilities.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: Bench studies using "numerical phantoms to analyze the accuracy of extraction/display... as well as measurement calculations" clearly represent standalone algorithm performance.

7. The type of ground truth used

• SUREVolume Synthesis & US Cardiac Fusion: The ground truth for fusion success and alignment appears to be based on the assessment of "users of varying levels of experience" at clinical sites. This would fall under an expert consensus/assessment type of ground truth, though the number of experts and their specific consensus method are not detailed.
• Angio Viewer: The ground truth for measurement accuracy was the "predicate device" (Infinix Celeve-I: INFX-8000F) based on measurements obtained from it.
• CT/XA Cerebral Artery Morphological Analysis, MR Wall Motion Tracking, MR Coronary Tracking: The ground truth for these bench studies was "numerical phantoms" and "measurement calculations," implying a precisely defined, known truth.

8. The sample size for the training set

The provided document does not mention the sample size used for the training set for any of the applications. It focuses on the validation/verification studies.

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

The provided document does not mention how the ground truth for the training set was established, as it does not discuss the training process.

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Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

• Proton density (PD) (also called hydrogen density)
• Spin-lattice relaxation time (T1)
• Spin-spin relaxation time (T2)
• Flow dynamics
• Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K162183. This system is based upon the technology and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

This document describes a 510(k) submission for the Vantage Galan 3T, MRT-3020, V4.6 Magnetic Resonance Imaging (MRI) System. This submission is for modifications to an already cleared device, including increased gradient strength and additional software functionalities (MultiBand SPEEDER, PSIR, MOLLI, V-TISP).

The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's diagnostic performance against specific acceptance criteria for a new clinical indication. Therefore, some of the requested information regarding clinical study specifics (e.g., sample size for test set, number of experts for ground truth, MRMC study effect size) is not explicitly detailed in the provided text, as this type of submission typically relies on equivalence to a previously cleared device's performance.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance or report specific performance metrics like sensitivity, specificity, or AUC as it would for a novel diagnostic algorithm. Instead, the "acceptance criteria" are related to safety, functionality, and demonstration of substantial equivalence to the predicate device.

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

The document mentions "volunteer clinical imaging" was performed. However, it does not specify the sample size for this clinical imaging, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature) for any test set specifically used to evaluate the new software functionalities. This type of information is often provided in a more detailed testing report, which is typically part of the full 510(k) submission but not fully included in this summary.

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

This information is not provided in the document. As the submission focuses on modifications to an existing MRI system and demonstrating substantial equivalence, detailed diagnostic performance studies with adjudicated ground truth by experts are not typically the primary focus for this type of 510(k). The document states images are "interpreted by a trained physician," implying general clinical practice, not a specific expert panel for a study.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in this document. The device itself is an MRI scanner with enhanced sequences, not an AI-powered diagnostic aide designed to improve human reader performance directly.

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

The document describes an MRI system with new pulse sequences and gradient capabilities. It is not an "algorithm only" device in the sense of a standalone diagnostic software that produces an output without human interaction. The system produces images that are then interpreted by a trained physician. Therefore, a standalone (algorithm only) performance assessment, as might be done for an AI diagnostic algorithm, is not applicable in this context and was not performed.

7. The Type of Ground Truth Used

For the "volunteer clinical imaging" and general assessment of the MRI system, the ground truth for image quality and diagnostic information is implicitly tied to clinical interpretation by a trained physician, as stated in the Indications for Use. For evaluating the technical performance and functionality of the new sequences (PSIR, MOLLI, V-TISP, MultiBand SPEEDER), the ground truth would be based on expected physical principles of MR imaging and technical image quality metrics. There is no mention of pathology or outcomes data as specific ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The new software functionalities (PSIR, MOLLI, V-TISP, MultiBand SPEEDER) are described as "techniques" or "sequence enhancements." They are not presented as machine learning algorithms that require a distinct training set for model development in the typical sense. These are likely based on established MR physics principles and refined through engineering and technical validation.

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

As no distinct "training set" for a machine learning algorithm is discussed, the concept of establishing ground truth for a training set is not applicable in this context. The "ground truth" for the development and validation of these MR sequences would be based on principles of physics, signal processing, and expected image characteristics, verified through phantom and volunteer studies.

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The Diaqnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-AI600 are indicated for the visualization of structures, and dynamic processes with the human body usinq ultrasound and to provide image information for diaqnosis in the followinq clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial) and laparoscopic.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-AI700 and Aplio i600 Model TUS-A1600, V2.4 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.

This document describes the Toshiba Medical Systems Corporation Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4, a modified device, and compares it to a predicate device (Aplio i900/i800/i700, V2.1, K163702).

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

1. Table of Acceptance Criteria and Reported Device Performance

The device is substantially equivalent to its predicate device and offers several new features and improvements. Acceptance criteria are typically defined by demonstrating substantial equivalence to a legally marketed predicate device and meeting performance specifications through testing.

Specific performance assessments for new and improved features include:

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

• 3D Wall Motion Tracking (RV Analysis): n=11 for the correlation coefficient for volume measurement.
• Mitral Valve Analysis (MVA): Seventy (70) patients were included in a side-by-side comparison study. A cardiac phantom was also used.
• Auto-EF: A group of three volunteers for workflow improvement assessment. A clinical evaluation was also conducted (sample size not specified).
• Z-Score Measurement: Previously acquired fetal ultrasound data. (Sample size not specified)
• 4D Imaging for 2D Array transducers: Phantom studies and volunteer studies (number of volunteers not specified).
• Improvements to existing features: Phantom and volunteer studies (sample sizes not specified).

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" for most studies. However, the mention of "previously acquired fetal ultrasound data" for Z-Score implies retrospective data for that specific test. The mention of "volunteers" and "patients" suggests prospective data for other tests.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not explicitly describe an MRMC comparative effectiveness study where human readers improve with AI assistance. The testing focuses on the device's performance against predicate devices or pre-defined performance metrics, but not on human-AI collaboration.

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

The studies conducted for Auto-EF, 3D ACM, Z-Score Measurement, and MPI Measurement appear to be standalone tests of the algorithm's performance against defined criteria or phantoms. While Auto-EF also involved an assessment of workflow improvement with volunteers, the core performance checks for these features seem to be standalone.

7. The Type of Ground Truth Used

• 3D Wall Motion Tracking (RV Analysis): Comparison to the predicate function (Vivid E9, K131514 with GE EchoPAC, K120221).
• Auto-EF: "Appropriate clinical measurements" as expected.
• 3D ACM: Performance specifications for flow volume measurement using a pulsating flow phantom.
• Z-Score Measurement: Pre-obtained values of femur length (FL), biparietal diameter (BPD), or gestational age (GA) using fetal echocardiography.
• MPI Measurement: Correct measurement of velocity and time durations in a Doppler phantom, and correct MPI calculation according to predefined methods.
• Mitral Valve Analysis (MVA):
  • In vivo evaluation: "Basic function and performance" in visualization, measurements, workflow improvement, and interoperator variability using 70 patients.
  • Phantom study: Comparison of MVA software output measurements to equivalent parameters obtained from a Computed Tomography (CT) system.
• 4D Imaging for 2D Array transducers: Correct depiction of shapes and flow in a phantom, and performance "as intended" in clinical images on volunteers.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document describes verification and validation testing, but not details about model training.

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

This information is not provided in the given text, as training set details are absent.

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This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and anqioqraphic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

INFX-8000V, V7.0, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm/Ω-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

The provided text describes a 510(k) premarket notification for a medical device, the Infinix-i, INFX-8000V, V7.0, an image-intensified fluoroscopic x-ray system. The submission focuses on modifications to a previously cleared device (INFX-8000V, V6.35) and asserts substantial equivalence.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered:

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

The document does not explicitly state formal acceptance criteria with specific thresholds or provide a table of reported device performance against such criteria. Instead, it states that "test data demonstrates that the system modifications result in performance that is equal to or better than the predicate system." The evaluation was conducted through "System evaluation of image quality" and "Evaluation of items supported to improve image quality" using phantoms.

The improvements claimed are:

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

The document mentions that testing was conducted through "bench testing" and "utilizing phantoms" for image quality metrics.

• Sample size: Not specified. The term "phantoms" suggests artificial test objects rather than patient data.
• Data provenance: Not specified, but given the use of phantoms and bench testing, it's likely laboratory-generated data. There is no mention of patient data, clinical studies, country of origin related to patient data, or whether it was retrospective or prospective.

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)

This information is not provided in the document. The testing described focuses on objective image quality metrics using phantoms, not on human expert interpretation of clinical images to establish ground truth.

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

This information is not provided as the testing method described does not involve human adjudication of clinical cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any indication that the device incorporates AI or is intended to assist human readers in image interpretation. The device is described as an "Image-intensified fluoroscopic X-ray system" with improvements to image processing and hardware.

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

The document describes "System evaluation of image quality" and "Evaluation of items supported to improve image quality" utilizing phantoms. This suggests standalone technical performance testing of the device's image output, without a human in the loop for interpretation in a clinical context. However, it's not an "algorithm only" performance in the sense of an AI model, but rather the performance of the complete imaging system.

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

Given the reliance on "phantoms" for image quality metrics, the "ground truth" would be the known and controlled characteristics of the phantoms themselves (e.g., specific spatial resolution patterns, contrast levels, signal-to-noise ratios). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth.

8. The sample size for the training set

This information is not provided. The document describes an update to an existing X-Ray system, not the development of a machine learning or AI algorithm that typically requires a 'training set'.

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

This information is not provided as there is no mention of a training set or machine learning algorithms in the document.

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The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

The Xario200 Model TUS-X200 and Model TUS-X200S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

The provided text describes modifications to an ultrasound system, the Xario 200 Diagnostic Ultrasound System V6.0, and states that these modifications do not change the intended use of the device. The modifications primarily involve the addition of new transducers and implementation of previously cleared software options. Therefore, the acceptance criteria and study information provided are primarily focused on demonstrating that the new transducers and software features perform as intended and are substantially equivalent to previously cleared devices or features.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the device's overall performance. Instead, it refers to the device performing "as intended" for the new features based on comparisons to predicate software/devices. The criteria for demonstrating safety and effectiveness likely included successfully fulfilling the intended use, maintaining image quality, and adhering to applicable medical device standards.

Study Information

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

   • 2D Wall Motion Tracking: "Representative clinical images of volunteers were obtained." The exact sample size is not specified. The data provenance is implied to be clinical, but the country of origin is not detailed. Given the company is "Toshiba Medical Systems Corporation" in Japan and "Toshiba America Medical Systems, Inc" in the USA, it could be from either or both.
   • Shear Wave: "Bench testing was done using an elasticity phantom." This indicates a non-human, controlled setting. No specific sample size (e.g., number of phantoms or measurements) is provided.
   • Transducers: No specific test set size or data provenance is mentioned for the general performance of the new transducers beyond their listed clinical applications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The document states "it was concluded" for 2D WMT and "As concluded in the study" for Shear Wave, implying expert assessment, but details about the number or qualifications of these experts are missing.

3. Adjudication method for the test set: Not specified.

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: Not explicitly stated. The document mentions 2D WMT "compared to predicate software", but this does not describe a comparative effectiveness study involving human readers with and without AI assistance for improved performance. The device itself is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI algorithm for interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes bench testing for Shear Wave and clinical image evaluation for 2D WMT. While these tests evaluate the algorithm/feature's performance and output, it's not clear if a standalone algorithm-only performance assessment without any human review or interpretation of the output was conducted or reported. However, for an ultrasound system, the output (images, measurements) is inherently for human interpretation.

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

   • 2D Wall Motion Tracking: The phrase "Representative clinical images of volunteers were obtained" and "performs as intended" suggests a comparison against expected normal cardiac function and/or comparisons with the predicate device's output, likely adjudicated by clinical experts.
   • Shear Wave: "Bench testing using an elasticity phantom" implies a known, controlled physical property as ground truth for measurement accuracy and precision.

7. The sample size for the training set: Not applicable and not mentioned. This document pertains to a diagnostic ultrasound system and its software features, not an AI/ML model that typically requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

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Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

• · Proton density (PD) (also called hydrogen density)
• · Spin-lattice relaxation time (T1)
• · Spin-spin relaxation time (T2)
• · Flow dynamics
• · Chemical Shift

Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Titan (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K152371. This system is based upon the technology, software and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

The provided document does not contain information about specific acceptance criteria, a study proving device conformance to those criteria, or details regarding the performance of the device against such criteria. The document is a 510(k) premarket notification for a Magnetic Resonance Imaging (MRI) system (Vantage Titan 3T, MRT-3010/A7, M-Power GX).

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices by outlining:

• Device Description and Changes: The submission describes the MRI system and lists software functionalities being migrated from existing cleared devices (sequence enhancements, post-processing enhancements, R-wave detection improvement).
• Safety Parameters: It compares safety parameters (static field strength, operational modes, SAR, dB/dt, emergency shutdown) of the subject device with the primary predicate device, noting they are the "Same."
• Imaging Performance Parameters: It explicitly states "No change from the previous predicate submission, K152371," indicating that the imaging performance is considered equivalent to the cleared predicate and not re-evaluated with new acceptance criteria or studies.
• Indications for Use: No changes to the previously cleared indications for use.
• Design Control Activities: Mentions risk management activities for new software functionalities and pulse sequences, confirming the test methods are the same as those in previously cleared submissions and indicating conformity with design controls.
• Safety and Standards Conformance: States the device is designed and manufactured under Quality System Regulations and ISO 13485, and conforms to applicable IEC and NEMA standards.
• Software Documentation: References FDA guidance for software documentation for a moderate level of concern.
• Conclusion: Concludes that "Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."

Therefore, I cannot provide the requested table or detailed information on specific studies, sample sizes, expert qualifications, or adjudication methods related to specific acceptance criteria and device performance as this document addresses substantial equivalence rather than a new standalone performance evaluation against defined acceptance criteria. The "testing" mentioned is implicitly related to software validation and risk management applied to changes, assuming the underlying hardware and core imaging performance already met acceptance criteria in prior submissions.

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The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angiography procedures for the heart, chest, abdomen, pelvis and brain.

The XIDF-AWS801, Angio Workstation, V7.0 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

This document is a 510(k) summary for the Toshiba Medical Systems Corporation's XIDF-AWS801, Angio Workstation, V7.0. It is a modification of a previously cleared device (XIDF-AWS801, Angio Workstation, V6.20, K152785). The submission primarily focuses on establishing substantial equivalence to the predicate device and does not provide detailed acceptance criteria or a specific study demonstrating performance against such criteria.

However, based on the provided text, we can infer some information relevant to the request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It focuses on the substantial equivalence argument, asserting that "system modifications result in performance that is equal to or better than the predicate system." The key performance aspects implicitly covered by the modifications and safety assessment are:

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

The document does not specify a distinct "test set" for performance evaluation in terms of number of cases or data provenance. The assessment relies on the modifications made to the predicate device and the validation of those changes.
The text mentions "test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." However, no details on the size or characteristics of this test data are provided. It does not mention retrospective or prospective studies or the country of origin for any data used in this specific submission.

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

The document does not detail a specific "test set" with ground truth established by experts for this submission.
For the "Cerebral Aneurysm Analysis" and "IV-LINQ (OCT/IVUS integration module)" applications, it mentions that the IV-LINQ module is "[imported] and used under the supervision of a cardiologist or radiologist." For the Cerebral Aneurysm Analysis, it states "[the software] can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio." This implies that the ground truth for these features would typically be clinical assessment by qualified specialists (cardiologists or radiologists), but the number of experts or their years of experience for any specific validation data is not provided in this document.

4. Adjudication Method for the Test Set

No details on an adjudication method (e.g., 2+1, 3+1, none) are provided as there is no explicitly defined external "test set" with expert review mentioned for this submission. The internal testing refers to "software verification and validation testing."

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. There is no mention of human readers improving with or without AI assistance, nor any effect size. This submission focuses on modifications to an existing workstation and demonstrating substantial equivalence, not a comparative efficacy study of AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly describe a standalone (algorithm only) performance study. The device, XIDF-AWS801, Angio Workstation, V7.0, is an "Angio Workstation" and includes "Angio Workstation 3D viewer" and is "used in combination with an interventional angiography system." While it contains sophisticated software modules (e.g., Cerebral Aneurysm Analysis, IV-LINQ), the submission positions them as part of an integrated workstation and does not report on their isolated algorithmic performance. The focus is on the integrated system's equivalence.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance validation. However, given the nature of the applications (Cerebral Aneurysm Analysis, IV-LINQ for stent visualization and measurement), it can be inferred that:

• For the Cerebral Aneurysm Analysis, ground truth for aneurysm detection and measurement would ideally come from definitive clinical diagnosis and potentially other validated imaging modalities or surgical findings.
• For IV-LINQ, the ground truth for stent visualization and measurement would likely be based on expert clinical assessment by cardiologists or radiologists using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) images, potentially compared with angiographic or other invasive measurements.
• For general image quality improvements, the ground truth would be based on qualitative and quantitative assessments against established imaging standards and clinical expectations.

8. Sample Size for the Training Set

The document does not specify the sample size used for any training set. It describes software modifications and the integration of modules "migrated" or "introduced" from previously cleared devices (K162614, K151780, K151091). These previously cleared devices or modules may have undergone their own training and validation, but details are not included in this K172646 submission.

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

As no training set is described, the document does not provide information on how ground truth was established for any training set.

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The Ultimax-i multipurpose digital X-ray system is designed for gastrointestinal studies, general radiography, and fluoroscopy.

The Ultimax-i system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast enhanced studies, nonvascular contrast-enhanced studies, support of vascular IVR, and general radiography.

Note: This system is not intended for cardiovascular contrast studies or interventional radiology procedures for the cardiac or cerebral blood vessels.

Ultimax-i, DREX-UI80, V1.60 is an image intensified fluoroscopic x-ray system.

The provided text is a clearance letter from the FDA for a medical device (Ultimax-i, DREX-UI80, V1.60). This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and can be sold.

However, a 510(k) clearance letter does not typically contain detailed information about the acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies in the way you've requested. These details are part of the original 510(k) submission to the FDA, which is a much more extensive document. The clearance letter only summarizes the outcome of the FDA's review.

Therefore, based solely on the provided text, I cannot answer the majority of your questions about the acceptance criteria and the study proving the device meets them. The text primarily focuses on regulatory information, indications for use, and contact details.

Here's what I can extract and what I cannot from the given text:

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

• Cannot provide. This information is not present in the FDA clearance letter. The letter confirms substantial equivalence, but not the specific performance metrics or acceptance criteria used in the underlying studies.

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

• Cannot provide. This information is not present in the FDA clearance letter.

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):

• Cannot provide. This information is not present in the FDA clearance letter.

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

• Cannot provide. This information is not present in the FDA clearance letter.

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:

• Cannot provide. The device is an "Image intensified fluoroscopic x-ray system" and a "multipurpose digital X-ray system." There is no mention of "AI" or "human readers" in the context of comparative effectiveness in this document. This suggests it's a traditional imaging system, not an AI-powered diagnostic aide. Therefore, an MRMC study comparing human readers with and without AI assistance is highly unlikely to have been conducted for this type of device as described here.

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

• Cannot provide. As noted in point 5, there's no indication of an "algorithm" or AI component that would have standalone performance. This appears to be a physical imaging system.

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

• Cannot provide. This information is not present in the FDA clearance letter.

8. The sample size for the training set:

• Cannot provide. This information is not present in the FDA clearance letter, and training sets are typically associated with machine learning/AI models, which this device does not appear to be.

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

• Cannot provide. This information is not present in the FDA clearance letter.

In summary, the provided document is a regulatory clearance letter, not a scientific study report or the full 510(k) submission. It confirms market authorization based on substantial equivalence to a predicate device, but it does not detail the specific performance studies, methodologies, or data used to establish that equivalence.

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