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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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The MAGNETOM Aera and the MAGNETOM Skyra systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectro-scopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Aera and the MAGNETOM Skyra systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.

MAGNETOM Aera (1.5 T) and MAGNETOM Skyra (3 T) are similar to the previously cleared MAGNETOM Espree and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.

The MAGNETOM Aera and the MAGNETOM Skyra systems will be available in fixed and mobile configurations.

The Siemens MAGNETOM Aera and MAGNETOM Skyra systems are Magnetic Resonance Diagnostic Devices (MRDD). The study described in the provided documents did not involve a clinical study with human patients to establish acceptance criteria or device performance in the traditional sense (e.g., diagnostic accuracy, sensitivity, specificity).

Instead, the study's purpose was to demonstrate substantial equivalence to previously cleared predicate devices (MAGNETOM Espree and MAGNETOM Verio) by showing that the new systems conform to established safety and performance standards for MRDDs.

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

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Study" and Acceptance:

The "study" for these devices was a series of technical measurements and comparisons to demonstrate that the MAGNETOM Aera and Skyra meet internationally recognized standards for safety and that their performance is equivalent to that of the predicate devices. This type of testing is common for demonstrating substantial equivalence for medical devices that are refinements or updates to existing technology rather than entirely new diagnostic methods.

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

• Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" consisted of the MAGNETOM Aera and MAGNETOM Skyra devices themselves, subjected to various technical measurements and comparisons against established standards and predicate device performance.
• Data Provenance: The data provenance is from technical measurements performed on the devices according to NEMA, IEC, and ISO standards. It is not patient data from a specific country or collected retrospectively/prospectively.

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

• This is not applicable as the "ground truth" for this submission was based on established engineering and physics standards (IEC, ISO, NEMA) and the performance characteristics of predicate devices. There was no diagnostic "ground truth" derived from expert interpretation of images in a clinical study. The standards themselves represent a form of "expert consensus" in the engineering and medical device community.

4. Adjudication Method for the Test Set

• Not applicable for this type of technical performance and safety validation.

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, an MRMC comparative effectiveness study was not done. The submission is for an MRI system, not an AI-powered diagnostic tool, and it focuses on the safety and technical performance of the scanner itself.

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

• Not applicable. This device is an MRI system, which requires a human operator and physician interpretation. It is not an algorithm that operates standalone.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating the devices was based on:
  • International Safety and Performance Standards: NEMA, IEC, and ISO standards for MRI devices.
  • Predicate Device Performance Data: Comparisons were made to the established performance of the legally marketed Siemens MAGNETOM Espree (1.5T) and MAGNETOM Verio (3T) systems.

8. The Sample Size for the Training Set

• Not applicable. This submission is for an MRI hardware system, not a machine learning algorithm that requires a training set of data.

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

• Not applicable as there was no training set for a machine learning algorithm.

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