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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.

The study primarily focuses on demonstrating that the new 3T system, despite changes in field strength and associated hardware/software, maintains the safety profile and "imaging performance" (qualitatively, meaning it produces diagnostically usable images) comparable to its predicate 1.5T device, while adhering to relevant international standards for medical electrical equipment.

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

The document states: "Additionally, volunteer studies were conducted to verify imaging performance."

• Sample Size: Not specified. It only mentions "volunteer studies" (plural), suggesting more than one, but no specific number of volunteers is provided.
• Data Provenance: Not explicitly stated, but given Toshiba Corporation is in Japan and the submission is to the US FDA, the volunteer studies could have been conducted in Japan, the US, or elsewhere. It is a prospective collection for the purpose of verifying imaging performance with the new device.

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

• The document does not specify the number of experts used for reviewing the images from the volunteer studies.
• It does mention the intended output: "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." This implies that expert interpretation is expected for clinical use, but not for the "verification" process itself.
• No qualifications for "experts" (if any were involved in verifying performance) are provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set (volunteer studies). The purpose of these studies was "to verify imaging performance," which likely refers to image quality and diagnostic utility, rather than specific diagnostic accuracy for a particular condition.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
• This device is an MRI system itself, not an AI-powered diagnostic tool, so such a study would not be relevant to its regulatory clearance in this context. The comparison is between the new 3T MRI device and a previous 1.5T MRI device.

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

• No, a standalone (algorithm only) performance study was not done.
• Similar to point 5, this device is a medical imaging system, not an AI algorithm. Its performance is evaluated on its ability to produce high-quality diagnostic images.

7. Type of Ground Truth Used for the Test Set

For the "volunteer studies," the "ground truth" was likely based on:

• Qualitative assessment of image quality: Experts would likely assess image clarity, resolution, contrast, artifact levels, and overall diagnostic interpretability against established standards for MRI.
• Physiological normalcy/absence of pathology in healthy volunteers: If healthy volunteers were used, the "ground truth" would be the expected normal anatomy and physiology, against which the MRI images would be evaluated for accuracy of representation.
• It is not pathology, outcomes data, or expert consensus on specific disease diagnosis from the text provided, as it was for "verifying imaging performance" in volunteers.

8. Sample Size for the Training Set

• Not Applicable. The Vantage Titan 3T is a hardware imaging system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI models.
• The software changes mentioned (new RF amplifier control, gradient power supply control, magnet supervisory control, modified SAR/distortion databases, new software platform) refer to engineering and control software, not AI training data.

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

• Not Applicable. As explained in point 8, there is no "training set" for an AI algorithm in this context. The "ground truth" for the device's operational software would be derived from engineering specifications, physics principles, and established safety standards.

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