(96 days)
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.
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.
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: |
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.