(35 days)
E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ MR images correspond to the spatial distribution of protons (hydrogen nucle) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-latice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
The E-scan XQ is a magnetic resonance (MR) system. The modified system is composed of a patient positioning table, magnetic unit, operating console (PC unit, keyboard, mouse, monitor, operating table), electronics box with filter panel, and modular shielding box. The modifications from the cleared version (K020164) include a modified system configuration, new operating tables, upgrading of the electronics, and a new software release. These modifications are stated to not affect the intended use or alter the fundamental scientific technology of the device.
This document is a 510(k) premarket notification for modifications made to the E-Scan XQ MRI system. It's not a study report proving a device meets acceptance criteria through clinical or technical performance testing with a specific outcome measure like diagnostic accuracy. Instead, it demonstrates substantial equivalence to a previously cleared device (E-Scan XQ K020164) based on similar technological characteristics and unchanged intended use.
Therefore, many of the requested categories (acceptance criteria, reported performance, sample size, ground truth, expert consensus, MRMC study, standalone performance) are not applicable (N/A) in the context of this type of submission. The comparison is primarily against the specifications of the predicate device, not clinical performance metrics against a defined standard.
However, I can extract the information provided regarding the modification and the comparison to its predicate.
Here's a summary of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) amendment for modifications, the "acceptance criteria" are implicitly the maintenance of, or improvement upon, the technological characteristics of the predicate device, while ensuring the intended use is not altered. The "reported device performance" is a comparison of the modified device's technical specifications against the predicate.
| Characteristic | Predicate Device (E-scan XQ K020164) | Modified Device (E-scan XQ modified) | Acceptance / Performance Comment |
|---|---|---|---|
| Pulse Sequences | Orthogonal Multi-planar Scout, Spin Echo T1 (set1), Spin Echo T2 (set2), Multi-Echo (se_pd_t2), Inversion Recovery (ir), Short TI Inversion Recovery (stir), Spin Echo Half Echo (set1he), Spin Echo Half Scan (set1hf), Turbo SE T2 weighted and Turbo ME (tse, tme), Gradient Echo (ge), Short Time Inversion Recovery Gradient Echo (ge_stir), Gradient Echo 3D (t3d_t1), Gradient Echo 3D contrast enhancement (3d_ce), Real Time | Orthogonal Multi-planar Scout, Spin Echo T1 (set1), Spin Echo T2 (set2), Multi-Echo (se_pd_t2), Inversion Recovery (ir), Short TI Inversion Recovery (stir), Spin Echo Half Echo (set1he), Spin Echo Half Scan (set1hf), Turbo SE T2 weighted and Turbo ME (tse, tme), Gradient Echo (ge), Short Time Inversion Recovery Gradient Echo (ge_stir), Gradient Echo 3D (t3d_t1), Gradient Echo 3D contrast enhancement (3d_ce), Real Time | Unchanged (Meets acceptance criterion of maintaining existing imaging capabilities) |
| Sequence Parameters (High Res) | Not explicitly detailed as "High Resolution" sequences with fixed TEs. | Added: High Resolution se_26 (TE=26ms), se_26_hf (TE=26ms), se_18_he (TE=18ms), tse_80 (TE=80ms), tse_50 (TE=50ms), tme (first echo 28ms, second echo 90ms), ge_16 (TE=16ms), ge_stir_25 (TE=25ms) | New feature/improved performance: These are particular versions of standard sequences with maximum acquisition matrix 512x512 (instead of 256x256 of non-High Resolution), aiming for best compromise between S/N and high resolution. This is an improvement. |
| Acquisition Matrix | 2D FT: 192x128 to 256x256; 3D FT: 192x128 to 256x256, slice encoding 24 to 128. | 2D FT for non High Resolution: 192x128 to 256x256; 2D FT for High Resolution: 192x128 to 512x512; 3D FT: 192x128 to 256x256, slice encoding 24 to 128. | Improved performance: Increased raw data matrix dimensions (up to 512x512 for High Resolution sequences) compared to the prior max of 256x256, allowing for higher resolution images. |
| Fringe Field (0.5 mT line) | X: 1.5 m front; 1.2 m rear; Y: 1.3 m; Z: 1.5 m | X: 1.34 m front; 1.06 m rear; Y: 1.25 m; Z: 1.29 m | More precise characterization of data (Specification update, not necessarily a performance change in itself, but implies refinement) |
| Gradients System - Control System | Digital, based on DSP SHARC 66 Mips, 132 MFlops, 0.5 Mbit Memory; 1.1515 nsec Instruction rate; 4 independent channels (X - Y - Z - Bo); DAC 18 bit - updating every 7.2 µs. | Digital electronic, based on DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM; 4 independent channels (X,Y,Z, Bo); DAC 18 bit - update every 7,2 µs. | Technological updating: Improved DSP (higher MFLOPs, increased memory) suggests potential for improved control and efficiency. |
| Magnetic Compensation System | Digital electronic based on DSP SHARC 66 Mips, 132 MFlops, 0.5 Mbit Memory. | Digital electronic, based on DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM. | Technological updating: Improved DSP suggests potential for more robust magnetic field control. |
| A/D Conversion | Baseband conversion; 2 A/D converter 16 bit 78 kHz sampling; 2 digital low-pass filter (bandwidth up to 0.464xfc, fc = 78.125 KHz/n). | For each channel: 3 MHz conversion of RF signal; A/D converter 14 bit 20 MHz sampling; digital demodulation; digital low-pass filter (bandwidth up to 0.43 x fc, fc from 156.25 to 4.882 kHz). | Technological updating / Improved performance: Higher sampling rate (20 MHz vs 78 kHz) and different conversion method (3 MHz RF conversion vs baseband) indicates a significant upgrade in signal acquisition. |
| Synthesizer | Digital, through DSP SHARC 66 Mips, 132 MFlops, 0.5 Mbit Memory; resolutions: 1.2 Hz frequency, 256 levels amplitude, 1°4° phase; stability |
§ 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.