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Vantaqe Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display analomic 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 mağnetic 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.

Device Description

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.

AI/ML Overview

Analysis of K132160 for Acceptance Criteria and Study Details

The provided document K132160 relates to a 510(k) premarket notification for software functionalities added to the Toshiba Vantage Titan 3T MRI system (Model MRT-3010/A5). It's important to note that this submission primarily concerns software changes and their impact on safety and performance parameters, rather than a new diagnostic algorithm or a comparative effectiveness study for a new clinical indication. Therefore, the typical structure for reporting acceptance criteria and study details for an AI/algorithm-driven diagnostic device showing clinical performance metrics may not fully apply in this context.

Based on the document, the "acceptance criteria" and "device performance" are primarily framed around compliance with established safety standards and maintaining equivalence in imaging performance compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for software updates to an existing MRI system, the acceptance criteria are largely focused on demonstrating that the updated system continues to meet safety and performance standards, or improves on flexibility without compromising safety. There aren't specific quantitative accuracy metrics for diagnosing a condition, but rather operational and safety specifications.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Vantage Titan 3T with new software)
Safety Parameters	1. Static Field Strength: Maintain 3T	3T (Same as Predicate)
	2. Operational Modes: Remain in 1st Operating Mode	1st Operating Mode (Same as Predicate)
	3. Safety Parameter Display: Display SAR dB/dt	SAR dB/dt (Same as Predicate)
	4. Operating Mode Access Requirements: Allow screen access to 1st level operating mode	Allows screen access to 1st level operating mode (Same as Predicate)
	5. Maximum SAR: ≤ 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2010)) Note: Updated standard compared to predicate.	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2010)) (Complies with updated standard)
	6. Maximum dB/dt: < 1st operating mode specified in IEC 60601-2-33 (2010) Note: Updated standard compared to predicate.	< 1st operating mode specified in IEC 60601-2-33 (2010) (Complies with updated standard)
	7. Potential Emergency Condition & Shutdown: Provide means for shutdown (e.g., Emergency Ramp Down Unit for collision hazard for ferromagnetic objects).	Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects (Same as Predicate)
Imaging Performance Parameters	No change in imaging performance from the previous predicate submission (K120487). This implies maintaining or exceeding the previous performance levels for aspects like image quality, signal-to-noise ratio, resolution, etc., for the general imaging capabilities. The specific software updates add new capabilities but are not described as changing the fundamental imaging performance of existing sequences.	"No change from the previous predicate submission (K120487)." This indicates that the imaging performance for the core functionalities remains equivalent, and the added software features are enhancements that are also expected to meet appropriate performance characteristics (though specific metrics for 3D ASL, 3D MRS, etc., are not detailed in this summary).
Intended Use	Maintain the previously cleared indication for use.	Vantaqe 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. Also capable of non-contrast enhanced imaging (MRA). (No changes to previously cleared indication K120487).
Design Control & Standards	Compliance with applicable recognized consensus standards (e.g., IEC60601-1, IEC60601-1-2, IEC60601-2-33, IEC62304, IEC62366).	The submission states "Testing was done in accordance with applicable recognized consensus standards as listed below" and lists relevant IEC standards. The difference in SAR/dBdt criteria is explicitly cited as conforming to the newer IEC 60601-2-33 (2010) standard.

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

The document does not specify a sample size for a test set in the context of clinical studies with patients/images for diagnostic accuracy. This is because the submission is for software updates to an MRI scanner rather than a diagnostic algorithm that analyzes images for a specific condition.

The "testing" mentioned refers to engineering verification and validation (V&V) of the software functionalities and safety parameters, which would typically involve phantom studies, limited human subject testing for comfort/safety, and functional testing on the device itself.

Test Set Sample Size: Not applicable/not specified for diagnostic accuracy. Testing would be against technical specifications and safety standards, likely involving hardware and software in a controlled environment.
Data Provenance: Not applicable for diagnostic image data. The "testing" pertains to the device functionality, and data would be generated from the device itself or phantoms for technical validation. The manufacturing site is in Japan (Toshiba Medical Systems Corporation).

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

This question is not applicable in the context of this 510(k) summary. The ground truth for this type of submission is typically adherence to engineering specifications, safety standards (e.g., SAR limits), and functional performance for image acquisition (e.g., sequence parameters, distortion correction effectiveness). These are validated through technical measurements and comparisons, not expert interpretation of diagnostic images for a clinical outcome.

4. Adjudication Method for the Test Set

Given that the "test set" here refers to technical validation against specifications and safety standards rather than a clinical diagnostic accuracy study, adjudication methods like 2+1 or 3+1 are not applicable. The testing would involve objective measurements and comparisons by engineers and possibly physicists to confirm compliance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done or reported in this summary. This type of study is relevant for evaluating the impact of a diagnostic AI algorithm on human reader performance. This submission is for software updates to an MRI scanner, which primarily affects how images are acquired and processed, not how a human interprets them using an AI assistant.

Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.

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

No, a standalone performance evaluation (in the sense of a diagnostic algorithm without human input) was NOT done or reported. The device is an MRI scanner, which is an imaging modality. The software updates enhance the imaging capabilities (e.g., 3D ASL, 3D MRS, distortion correction). These are fundamental tools for image acquisition, not standalone diagnostic algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this submission is technical specifications, established safety limits (e.g., SAR limits from IEC standards), and the expected functional behavior of the software. This is verified through engineering testing, phantom studies, and comparison to the predicate device's established performance and indication of use. There is no mention of pathology, expert consensus on disease, or outcomes data as ground truth in this 510(k) summary.

8. The Sample Size for the Training Set

Not applicable. This submission is for software updates to an MRI scanner. It does not describe an AI/ML algorithm that requires a "training set" of data for learning diagnostic patterns. The software functionalities are based on physics principles, signal processing, and numerical algorithms.

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

Not applicable. As there is no "training set" in the context of an AI/ML algorithm, the concept of establishing ground truth for it does not apply to this submission.

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