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LiverMultiScan (LMSv2) 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 (LMSv2) 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 (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.

These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse.

LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.

LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow.

LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.

LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists.

LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.

LiverMultiScan (LMSv2) offers the following.

• Advanced visualisation of MR data.
• Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage).
• Circular region of interest statistics.
• Snapshot of images to include in a report.
• Report to include region statistics, snapshot images and user-entered text.
• Export of snapshot images to report.

Here's a summary of the acceptance criteria and study details for LiverMultiScan (LMSv2) based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are framed in terms of accuracy, repeatability, reproducibility, and equivalence to the predicate device (LMSv1) for the measurements of T1 (corrected T1 or cT1 for in vivo), T2*, and Proton Density Fat Fraction (PDFF, also referred to as triglyceride fat fraction).

Phantom Study Performance:

In Vivo Study Performance:

Conclusion: The document states that "all acceptance criteria were met," and LMSv2 is concluded to be substantially equivalent to LMSv1.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • In Vivo: The document mentions "in vivo volunteer data" but does not explicitly state the number of volunteers used for the test set.
  • Phantom: The document mentions "phantom scans" but does not explicitly state the number of phantoms or scans.
  • Substantial Equivalence (In Vivo): The document mentions "in vivo measurements" show specific equivalence values, implying a test set was used, but the size is not specified.
  • Substantial Equivalence (Phantom): Similarly, "phantom measurements" are cited for equivalence, but the sample size is not specified.
• Data Provenance: The document does not specify the country of origin of the data nor whether the studies were retrospective or prospective. It only mentions "volunteer scans" and "phantom scans."

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts, their specific qualifications, or their role in establishing ground truth for the test set. The device is intended to be used by trained operators, and reports interpreted by trained clinicians (radiologists, gastroenterologists, hepatologists).

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set. It does mention "intra-operator" and "inter-operator" variation, indicating that multiple readings by the same operator and different operators were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No explicit MRMC comparative effectiveness study is described where human readers' improvement with AI vs. without AI assistance is quantified. The evaluation focuses on the performance of the software itself and the variability introduced by operators using the software.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm (LiverMultiScan v2). The entire performance data presented in the tables (accuracy, repeatability, reproducibility, equivalence) represents the algorithm's performance. The "intra-operator" and "inter-operator" studies also demonstrate the variability introduced by the human-in-the-loop when using the standalone software.

7. Type of Ground Truth Used

• Phantom Studies: For phantom studies, the ground truth for T1 was based on "literature-reported underestimation of ground truth T1 using MOLLI techniques." For T2* and PDFF, the phantoms likely had known, controlled values for these parameters, which is implied by the term "ground truth" and the quantitative comparisons.
• In Vivo Studies: The document does not explicitly state how ground truth was established for "in vivo volunteer data." Given the measurements are for MRI parameters (cT1, T2*, PDFF), the "ground truth" for repeatability and reproducibility would likely be the measurements themselves when repeated under identical or varied conditions, rather than an external gold standard like pathology, unless otherwise specified. For accuracy, a reference standard might be implied, but it's not detailed.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

9. How Ground Truth for the Training Set was Established

The document does not describe how ground truth was established for the training set. It focuses on the validation and verification against user needs and intended use, and comparison to a predicate device, rather than the development or training of the algorithm itself.

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