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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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SURESubtraction Lung software is intended to aid in the visualization of lung parenchyma enhancement by subtracting a non-contrast enhanced volume from a contrast enhanced volume.

The SURESubtraction Lung, CSSL-001A, is a post-processing software that subtracts image information by comparison of two data sets, one of which is contrast enhanced. Registration software is used to match the two independent studies.

The provided text does not contain detailed information about specific acceptance criteria, a study proving the device meets those criteria, or most of the requested quantitative metrics (sample sizes, number of experts, adjudication methods, MRMC study, standalone performance, training set data).

However, it does offer some general insights into the device validation process. Here's a breakdown of what can be extracted and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative or qualitative metrics for acceptance criteria (e.g., sensitivity, specificity, image quality scores, agreement rates) are not provided in the document.

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

• Sample Size for Test Set: Not specified. The document only states "clinical data."
• Data Provenance: "clinical data at an investigational site." Country of origin is not specified, but it's likely related to either the submitting company (Toshiba Medical Systems Corporation, Japan) or Toshiba America Medical Systems, Inc., which has an office in Tustin, CA. The document does not explicitly state if the data was retrospective or prospective.

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

• This information is not provided in the document.

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

• This information is not provided in the document.

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

• An MRMC study is not explicitly mentioned. The document states that the software "aids in the visualization," implying assistance to a human reader, but does not quantify the improvement or describe a comparative effectiveness study design.

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

• The document describes the device as "intended to aid in the visualization" and for "post-processing," which suggests it's designed to be used with a human-in-the-loop. A standalone performance evaluation is not mentioned.

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

• The document implies that the ground truth for "abnormal blood perfusion correlating to thromboembolic disease such as pulmonary embolism" was used to assess the visualization capability. However, the specific method for establishing this ground truth (e.g., expert consensus on other imaging modalities, pathology, follow-up outcomes) is not detailed.

8. The sample size for the training set

• This information is not provided in the document. The document refers to "testing was conducted" but doesn't differentiate between training and test sets.

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

• This information is not provided in the document, as the training set itself is not mentioned.

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The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.

The MJAH-167A is intended to be used on a Toshiba 1.5T MR System

The Octave SPEEDER Head is a receive-only phased Array Coil that can receive NMR signal from head, cervical region and upper chest. The coil consists two parts of a head base, a removable anterior coil. The head base includes 7 coil elements, which are divided into 3 sections. The removable anterior coil includes 4 coil elements, which are divided into 2 sections: Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

This document is a 510(k) summary for the Octave SPEEDER Head (MJAH-167A), an MRI receive-only phased array coil. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (Atlas SPEEDER Head/Cervical coil, K083014) rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a novel AI algorithm might.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly stated in the provided text. The submission relies on "testing utilizing phantoms and accepted imaging quality metrics" and demonstrating that the new device does not change the indications for use or intended use.

Here's an analysis based on the provided text, addressing the points where information is available and noting when it's not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in a table. It instead relies on demonstrating "substantial equivalence" to a predicate device through conformity to recognized consensus standards and general statements about imaging quality.

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

• Sample Size: Not specified. The document mentions "sample phantom images and clinical images" but does not give a number for either.
• Data Provenance: Not specified. Based on the manufacturing site in Japan and the U.S. agent's location, the clinical images could be from either region, or a combination. The document mentions "clinical images," implying prospective or retrospective data from human subjects, but no specifics are given.

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

Not applicable in the context of this 510(k) summary. The evaluation focuses on physical device performance and equivalence, not diagnostic accuracy requiring expert interpretation for ground truth. The "testing was conducted utilizing phantoms and accepted imaging quality metrics," suggesting engineering and physics evaluations rather than clinical diagnostic assessments with expert reads.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is not based on diagnostic performance that would require adjudication.

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 an MRI coil, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This is a hardware device (MRI coil), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation largely refers to physical measurements and imaging metrics against established standards for MRI coil performance. For example:

• Phantoms: Phantoms are used as a controlled "ground truth" to measure parameters like signal-to-noise ratio (SNR), uniformity, and image artifact levels.
• Accepted Imaging Quality Metrics: These would be objective measurements of image quality, not derived from expert consensus on pathology or outcomes.
• Biocompatibility Testing: Demonstrates non-toxicity and non-irritation, which are established through standardized laboratory tests.
• Safety Parameters: Ground truth established by international standards (e.g., IEC60601-2-33) for dB/dt, SAR, and static field strength.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, so there is no training set in that context.

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

Not applicable, as there is no training set.

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The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.

The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

The provided text is a 510(k) summary for the Octave SPEEDER Spine, a magnetic resonance diagnostic device. It details the device's classification, contact information, manufacturing site, date of submission, intended use, description, safety parameters, and substantial equivalence to a predicate device.

However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for AI/algorithm-based devices.

Here's why and what the document does provide:

• Device Type: The Octave SPEEDER Spine is a receive-only phased array coil, essentially a hardware component for an MRI system. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.
• "Acceptance Criteria" in this Context: For this type of hardware, "acceptance criteria" generally refers to meeting safety standards and demonstrating that the device functions as intended within the MRI system, and that its image quality is comparable to or better than previously cleared devices.
• "Study" Information: The document refers to "testing" but not a formal study with detailed methodology, sample sizes, and expert reviews as would be expected for an AI product.

Here's a breakdown of what can be extracted or inferred based on your requested headings, with clarifications where the information is absent for an AI-focused interpretation:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The document mentions "phantom images and clinical images" but does not give a number of phantoms or patients/cases.
• Data Provenance: Not specified. "Clinical images" would imply collected data, but details like country of origin or whether it was retrospective/prospective are not present.

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

• This is not applicable and not mentioned. For a hardware device like an MRI coil, "ground truth" in the context of diagnostic interpretation by experts is not the primary assessment method. Image quality is typically assessed against physical phantoms (known configurations) and qualitatively by experts for clinical utility, but not in terms of diagnostic accuracy with a "ground truth" label in the way an AI would be.

4. Adjudication method for the test set

• Not applicable and not mentioned.

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. This is not an AI device. No MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• No. This is not an AI device.

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

• For the phantom imaging, the "ground truth" would be the known configuration of the phantom itself.
• For "clinical images," image quality is likely judged subjectively by imaging specialists and objectively by predefined metrics, rather than against a specific diagnostic "ground truth" derived from pathology or outcomes, as the coil's role is to acquire the image, not to interpret it diagnostically with an automated tool.

8. The sample size for the training set

• Not applicable / not mentioned. This device does not use a "training set" in the context of machine learning.

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

• Not applicable / not mentioned. This device does not have a "training set."

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The intended use of this system is to visualize structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis for cardiac and vascular.

The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel, Abdominal, Small Organ (Specify) (1), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial).

The APLIO ARTIDA SSH-880CV is a mobile Ultrasound Diagnostic System for cardiology and vascular imaging. It has a capability of providing a 3D real time image of a heart as well as 2D images. The system is consists of a main console, a color LCD display and several transducers. The compatible transducers are linear array, curved linear and phased array with a frequency range of 2.5 MHz to 7.5MHz. Accordingly it has various software options for cardiac and vascular examinations.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the substantial equivalence of the APLIO ARTIDA MODEL SSH-880CV V3.0 (subject device) to the APLIO ARTIDA MODEL SSH-880CV V2.0 (predicate device), with the addition of a new feature: Activation Imaging (AI) - 3D Wall Motion Tracking (3D WMT). The acceptance criteria for this new feature is qualitative and tied to its ability to display activation timing.

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

• Sample Size: 10 subjects.
• Data Provenance: The text states, "A clinical evaluation of Activation Imaging (AI) was conducted at a evaluation site for the validation of AI." No specific country of origin is mentioned, but the submitter's address is in Tustin, CA, USA, and the device manufacturer is Toshiba Medical Systems Corporation, Japan. This suggests it could be a US-based study or an international study. The study was prospective in nature, as indicated by "scheduled for routine Echocardiographic Evaluation."

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only mentions that subjects were "scheduled for routine Echocardiographic Evaluation by their physician," implying that physicians (likely cardiologists or specialized sonographers) were involved in the standard diagnostic process which would inform the assessment of "dyssynchrony."

4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

No MRMC comparative effectiveness study is mentioned. The study was a clinical evaluation of the AI feature itself, not a comparison of human readers with vs. without AI assistance. The focus was on whether the AI images provided activation timing, not on how it improved human reader performance.

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

Yes, a standalone evaluation was performed. The "pass/fail criterion was used to determine if the AI images provided the activation timing." This directly assesses the algorithm's output without requiring human interpretation for its performance evaluation against a specific criterion.

7. The Type of Ground Truth Used

The ground truth was established by assessing if the AI images "provided the activation timing" for subjects with "dyssynchrony." This implies a clinical assessment of myocardial movement from the acquired 3D images, likely evaluated against established medical understanding of cardiac dyssynchrony and activation timing. While not explicitly stated as "expert consensus," the nature of the evaluation for a diagnostic ultrasound feature inherently relies on clinical judgment and established diagnostic criteria within the medical field. It's an implicit clinical ground truth based on the physician's evaluation rather than a pathology result or outcome data.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. The focus is solely on the clinical evaluation of the new feature.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

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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 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.

The TSX-301B is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

The provided text lacks specific details regarding acceptance criteria and a detailed study proving the device meets them. The submission primarily focuses on the device's substantial equivalence to a predicate device and its ability to reduce radiation exposure through an iterative reconstruction algorithm.

However, based on the information available, here's an attempt to answer the questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria (e.g., minimum spatial resolution, contrast-to-noise ratio). It broadly mentions "accepted image quality metrics" and "reduction of radiation exposure."

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

• Sample Size for Test Set: Not specified. The document states "The testing conducted on this device utilized phantoms." There is no mention of human subject data, and therefore no information on the sample size of a test set derived from human subjects.
• Data Provenance: Not applicable, as testing was conducted on phantoms.

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

Not applicable, as testing involved phantoms, not human data requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable, as testing involved phantoms.

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 submission focuses on hardware and a reconstruction algorithm, not an AI-assisted diagnostic tool for human readers. There is no mention of a human-in-the-loop study or human reader performance.

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

Yes, the testing described appears to be a standalone evaluation of the device and its iterative reconstruction algorithm using phantoms. The document states, "The testing conducted on this device utilized phantoms and accepted image quality metrics." The focus is on the technical performance of the device itself and its ability to achieve lower doses while maintaining image quality.

7. The Type of Ground Truth Used:

For the phantom testing, the ground truth would be the known physical properties and compositions of the phantoms themselves, along with established metrics for image quality (e.g., spatial resolution targets, contrast targets).

8. The Sample Size for the Training Set:

Not applicable. The document describes a modification to an existing CT scanner (TSX-301B Aquilion Premium) with the addition of an iterative reconstruction algorithm. This is not a description of a machine learning model that would require a "training set" in the conventional sense for a completely new AI algorithm. The iterative reconstruction algorithm itself might have been developed and "trained" on data internally by the manufacturer, but this information is not provided in the 510(k) summary.

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

Not applicable, as this information is not provided and the context suggests a traditional iterative reconstruction algorithm rather than a machine learning model with explicitly defined training and ground truth from external datasets.

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

The main function of this system is to perform fluoroscopy /radiography of the interventional angiography system. Using the fluorescent scintillation effect of X-rays that have passed through the patient's body, image information is obtained for medical diagnosis treatment.

The provided text is a 510(k) summary for the Toshiba America Medical Systems INFX-8000V with 56 inch Monitor. This document is a pre-market notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria. Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is largely not present in this type of regulatory submission.

The document primarily focuses on:

• Device Description and Intended Use: The system performs fluoroscopy/radiography for interventional angiography, specifically for diagnostic and interventional procedures involving cardiac, abdominal, and lower limb blood vessels.
• Substantial Equivalence: It claims substantial equivalence to its predicate device, the INFX-8000V (K081582). This means it asserts that the new device is as safe and effective as the predicate, which has already been cleared for market.
• Safety Standards: Compliance with Quality System Regulations (21 CFR § 820, ISO 13485) and applicable parts of IEC60601-1 and 21 CFR §1020 is stated.
• Regulatory Clearance: The FDA's letter (K112054) confirms the finding of substantial equivalence.

Therefore, based only on the provided text, I cannot extract the information required to populate the table and answer the specific study-related questions. The document does not describe a performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the INFX-8000V with 56 inch Monitor. This information would typically be found in a separate performance study report, which is not included here.

However, I can extract what is provided regarding the device and its regulatory clearance.

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the given 510(k) summary. A 510(k) submission generally asserts substantial equivalence to a predicate device based on similar design, intended use, and technological characteristics, rather than presenting a de novo performance study against specific acceptance criteria. The document states compliance with general safety and performance standards (e.g., IEC60601-1, 21 CFR §1020), which serve as a baseline for all such devices, but not specific diagnostic performance metrics or acceptance thresholds for the device itself.

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

Not applicable/Not provided. The document does not describe a test set or a performance study involving patient data to demonstrate the device's diagnostic accuracy or performance.

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

Not applicable/Not provided. As no test set performance study is described, there is no mention of experts establishing ground truth.

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

Not applicable/Not provided. No test set is described.

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

Not applicable/Not provided. The device is described as a "Solid State X-Ray Imager" and "diagnostic X-ray system," not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant in this context and is not mentioned.

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

Not applicable/Not provided. The device is a hardware imaging system, not a standalone algorithm.

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

Not applicable/Not provided. No performance study necessitating ground truth is described.

8. The sample size for the training set:

Not applicable/Not provided. The device is a hardware imaging system and does not mention any machine learning or AI components that would require a "training set."

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

Not applicable/Not provided. No training set is described.

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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 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.

The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.

• . Field strength of magnet has been changed to 3T.
• . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
• . Number of RF amplifier channels is increased from 1 to 2.
• Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
• Software platform has been changed. .

Below is an analysis of the provided text regarding the Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T.

Device Name: Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparison study for regulatory clearance (510(k) submission) to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy metrics. The "acceptance criteria" here are based on safety parameters outlined by recognized consensus standards and a qualitative assessment of imaging performance.

115.7dB (peak) | (Higher, but implied within acceptable safety limits for 3T, compliance to IEC 60601-2-33) |

| Operational modes: 1st operating mode (SAR, dB/dt display, access req.) | Same |
| Maximum SAR: 4 W/kg for whole body (1st operating mode, IEC 60601-2-33) | Same |
| Maximum dB/dt:

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