(86 days)
Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional 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 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 us restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis.
The provided document is a 510(k) summary and FDA clearance letter for a Magnetic Resonance Diagnostic Device, the Toshiba Vantage Titan 3T (MRT-3010/A5). It primarily focuses on demonstrating substantial equivalence to a predicate device and safety parameters, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI-related metrics like standalone performance, MRMC studies, sample sizes for test/training sets, and expert-established ground truth, is not present in the provided text. The submission is for an MRI system and its software packages, not an AI/CADe device that typically undergoes such performance evaluations.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify performance-based acceptance criteria in the way one would for a diagnostic accuracy study. Instead, it details safety parameters to show equivalence to a predicate device.
| Item | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Static field strength | 3T | 3T |
| Operational Modes | 1st Operating Mode | 1st Operating Mode |
| Safety parameter display | SAR dB/dt | SAR dB/dt |
| Operating mode access requirements | Allows screen access to 1st level operating mode | Allows screen access to 1st level operating mode |
| Maximum SAR | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33(2002)) | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33(2002)) |
| 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.