(203 days)
Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy.
Version 3.1 software consists of two model upgrades to the FLEXART™ system. The MRT-50GP/E2 (Flexart™) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat supression. The MRT-50GP/H1 (Flexart™/Hyper) increases the gradient field strength over that of the Flexart™ .
This 510(k) summary describes upgrades to an MRI system (FLEXART™ V3.1), focusing on improvements in hardware and software. It primarily discusses safety parameters and imaging performance in the context of demonstrating substantial equivalence to a previously cleared device. Due to the nature of this submission (upgrades to an existing MRI system for improved image quality and functionality, rather than a novel AI/CAD device), many of the specific questions regarding AI device evaluation (e.g., acceptance criteria for diagnostic performance metrics, human reader studies, ground truth establishment) are not directly applicable or reported in this document.
Here's an analysis based on the provided text, highlighting what is and isn't available:
Analysis of Acceptance Criteria and Device Performance Study (K962138)
This submission (K962138) concerns upgrades to an existing Magnetic Resonance Device (FLEXART™ V3.1). The primary goal of the submission is to demonstrate substantial equivalence to a previously cleared device (K933018, FLEXART™) by showing that the upgrades improve performance without raising new questions of safety or efficacy.
Therefore, the "acceptance criteria" and "device performance" in this context are focused on safety parameters and qualitative imaging performance improvements rather than quantitative diagnostic accuracy metrics typically seen for AI/CAD products.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is an upgrade to an existing MRI system, the "acceptance criteria" are implicitly tied to maintaining or improving upon the safety and image quality of the predicate device, and demonstrating conformance with consensus standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (FLEXART™ V3.1) |
|---|---|---|
| Safety Parameters | - Max static field strength compliant. |
- Rate of change of magnetic field (τ=1000ms) compliant and below IEC standard.
- Max RF power deposition compliant.
- Acoustic Noise levels within acceptable limits (below 100 dB(A) for patient-observed levels). | MRT-50GP/E2:
- Max static field strength: 0.5 T (Same as predicate)
- Rate of change of magnetic field: 11 T/sec (Same as predicate)
- Max RF power deposition:
§ 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.