(96 days)
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 vield information that can be useful in diagnosis
The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System(K113093). Four software packages (Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT) , Cardiac Function Analysis, and Image filter EM AIDR are added to Vantage Titan 3T.
The provided text is a 510(k) summary for the Toshiba Vantage Titan 3T, v2.0 (MRT-3010/A5) MRI system. It describes the device and its intended use, focusing on software package additions to an already cleared predicate device (K113093). The document primarily addresses safety parameters and outlines the process of demonstrating substantial equivalence to the predicate device, especially regarding design control activities and adherence to recognized standards.
However, the document does not contain the specific information required to complete the table for acceptance criteria and device performance, nor does it provide details about a study designed to prove the device meets specific acceptance criteria in the way described in the prompt.
Here's why and what information can be extracted or inferred:
- Acceptance Criteria and Reported Device Performance: This section is not explicitly present. The document focuses on showing the new device is "substantially equivalent" to a predicate device by comparing safety parameters (which are identical) and outlining that the new software additions are consistent with the predicate's intended use. It doesn't define new performance-based acceptance criteria for the added software packages (Positioning Assist for Cardiac, DTT, Cardiac Function Analysis, Image filter EM AIDR) nor report specific performance metrics against such criteria.
- Study Design Information: The document states, "The test methods used are the same as those submitted in the previously cleared submissions (K113093). A declaration of conformity with design controls is included in this submission." This indicates that the validation relied on existing testing methodologies and design controls from the predicate device, rather than a new standalone study with a defined sample size, ground truth, experts, or adjudication methods for the specific software additions.
Therefore, the table and most of the detailed study questions cannot be answered from the provided text.
Inference/Extracted Information based on the provided text:
While a direct study with acceptance criteria is not detailed, the text implies that the "acceptance criteria" for the new software features were essentially demonstrating that they maintained the overall safety and imaging performance of the predicate device and performed their described functions as intended, within the framework of existing design controls. The study that "proves" this is the demonstration of substantial equivalence to the predicate device K113093, adhering to international standards for MR devices and software development.
Summary of what can be answered based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated for new features; inferred from substantial equivalence to predicate) | Reported Device Performance (Inferred from substantial equivalence to predicate) |
|---|---|---|
| Safety Parameters | Identical to predicate K113093: Static field strength (3T), Operational Modes (1st Operating Mode), SAR dB/dt display, 1st level operating mode access, Max SAR (4W/kg whole body), Max 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.