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510(k) Data Aggregation
(175 days)
LiverMultiScan (LMSv3)
LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse.
The main functionality of LiverMultiScan (LMSv3) includes:
- Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information
- Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction PDFF), T2*, T1 and ironcorrected T1 (cT1) of the liver.
- Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement.
- Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1).
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding reported performance for specific metrics like sensitivity, specificity, accuracy, etc., as one might expect for a diagnostic device. Instead, the performance testing focuses on the accuracy, repeatability, reproducibility, and inter-/intra-operator variability of quantitative measurements, and particularly on demonstrating substantial equivalence to a predicate device (LMSv2).
The acceptance criteria are implicitly defined by the reported performance ranges and the conclusion that the device performs "as well as its predicate" and that "all the testing results are well within the acceptance criteria."
| Metric / Test Type | Acceptance Criteria (Implicit from Study Conclusion) | Reported Device Performance (Summary) |
|---|---|---|
| Phantom Testing | ||
| T1 Accuracy | T1 measurements consistent with literature-reported underestimation for MOLLI techniques. | Up to 18.89% lower to ground truth (95% CI Limits of Agreement) |
| T2* Accuracy | Accurate over expected physiological range. | -9.31% to 7.53% of ground truth (95% CI Limits of Agreement) |
| DIXON PDFF Accuracy (30%) | Relatively accurate over expected physiological range; minor deviations due to known fat bias. | -28.93% to 6.83% (95% CI Limits of Agreement) |
| IDEAL PDFF Accuracy (30%) | Accurate over expected physiological range. | -5.05% to 10.70% (95% CI Limits of Agreement) |
| T1 Repeatability (same scanner) | Highly repeatable. | -13.88 to 14.47 ms (95% CI Limits of Agreement) |
| T2* Repeatability (same scanner) | Highly repeatable. | -0.89 to 1.43 ms (95% CI Limits of Agreement) |
| DIXON PDFF Repeatability (30%) | Highly repeatable. | -2.11 to 1.96% (95% CI Limits of Agreement) |
| IDEAL PDFF Repeatability (30%) | Highly repeatable. | -3.80 to 1.93 % (95% CI Limits of Agreement) |
| T1 Reproducibility (different scanners) | Reproducible between different scanners. | -2.66 to 10.78% (95% CI Limits of Agreement) |
| T2* Reproducibility (different scanners) | Reproducible between different scanners. | -3.43 to 2.42 ms (95% CI Limits of Agreement) |
| DIXON PDFF Reproducibility (30%) | Reproducible between different scanners. | -8.64 to 23.52% (95% CI Limits of Agreement) |
| IDEAL PDFF Reproducibility (30%) | Reproducible between different scanners. | -13.46 to 6.98% (95% CI Limits of Agreement) |
| In-Vivo Testing | ||
| cT1 Repeatability | Highly repeatable. | -94.38 to 63.38 ms (ROI); -76.93 to 59.39 ms (Segmentation) |
| T2* Repeatability | Highly repeatable. | -6.07 to 5.70 ms (ROI) |
| DIXON PDFF Repeatability | Highly repeatable. | -1.77 to 3.64 % (ROI); -1.20 to 1.06% (Segmentation) |
| IDEAL PDFF Repeatability | Highly repeatable. | -1.92 to 1.54% (ROI); -1.83 to 1.28 % (Segmentation) |
| cT1 Reproducibility (between scanners) | Reproducible between scanners. | -89.70 to 120.58 ms (ROI); -84.91 to 121.79 ms (Segmentation) |
| T2* Reproducibility (between scanners) | Reproducible between scanners. | -3.68 to 6.35 ms (ROI) |
| DIXON PDFF Reproducibility (between scanners) | Reproducible between scanners. | -6.21 to 2.63% (ROI); -3.14 to 0.88% (Segmentation) |
| IDEAL PDFF Reproducibility (between scanners) | Reproducible between scanners. | -2.66 to 2.77% (ROI); -1.74 to 1.21% (Segmentation) |
| cT1 Intra-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -27.38 to 28.33ms (ROI); -20.81 to 13.06ms (Segmentation) |
| T2* Intra-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -2.29 to 2.91 ms (ROI) |
| DIXON PDFF Intra-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -0.78 to 1.90 % (ROI); -0.29 to 0.45% (Segmentation) |
| IDEAL PDFF Intra-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -1.26 to 1.05% (ROI); -0.16 to 0.14% (Segmentation) |
| cT1 Inter-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -48.05 to 39.89ms (ROI); -37.84 to 26.51ms (Segmentation) |
| T2* Inter-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -2.64 to 4.90 ms (ROI) |
| DIXON PDFF Inter-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -2.27 to 4.57% (ROI); -0.55 to 1.22% (Segmentation) |
| IDEAL PDFF Inter-Operator Variability | Variation well within prescribed criteria; minor additional variation for ROI method. | -2.09 to 1.82 % (ROI); -0.37 to 0.26% (Segmentation) |
| cT1 Worst-Case Variability | Highly reproducible. | -126.52 to 104.19 ms (ROI); -65.27 to 120.27 ms (Segmentation) |
| T2* Worst-Case Variability | Highly reproducible. | -3.68 to 6.35 ms (ROI) |
| DIXON PDFF Worst-Case Variability | Highly reproducible. | -2.04 to 0.76 % (ROI); -2.72 to 1.24% (Segmentation) |
| IDEAL PDFF Worst-Case Variability | Highly reproducible. | -3.75 to 2.83% (ROI); -1.92 to 1.35% (Segmentation) |
| Substantial Equivalence (LMSv3 vs. LMSv2.1) | Performs as well as its predicate. | |
| Phantom T1 | Negligible difference. | -1.96 to 2.09ms (95% CI Limits of Agreement) |
| Phantom T2* | Negligible difference. | -0.08 to 0.08ms (95% CI Limits of Agreement) |
| Phantom DIXON PDFF ( |
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