(246 days)
LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.
These images and the physical parameters derived from the images, when interpreted by a trained physician, yield information that may assist in diagnosis.
LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse.
LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
LMS 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.
LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.
LMS allows users 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 (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.
LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.
LiverMultiScan offers:
- . Advanced visualization of MR data
- . Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and 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 and report to storage
- . Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data
Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems.
- Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution
The provided documents (FDA 510(k) summary and letters for LiverMultiScan) describe the device and its intended use, and generally state that it has been validated and verified. They assert that LiverMultiScan is substantially equivalent to the predicate device, Siemens syngo MR E11A software, for both safety and effectiveness.
However, the provided text does not include specific acceptance criteria, detailed study results, or quantitative performance metrics that would allow for a comprehensive breakdown as requested. The document focuses on regulatory compliance and comparison to a predicate device, rather than providing the granular technical study details.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document generally states that "performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device," and "performs at least as safely and effectively as the listed predicate device." However, no specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error rates) or reported device performance values are provided.
2. Sample size used for the test set and the data provenance
- Missing. The documents mention "validated with volunteer and phantom scans" for performance but do not specify the sample size for any test set or the provenance (country of origin, retrospective/prospective nature) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing. The documents mention that images and parameters should be "interpreted by a trained physician" but do not specify the number or qualifications of experts used to establish ground truth for testing.
4. Adjudication method for the test set
- Missing. No adjudication method (e.g., 2+1, 3+1, none) for a test set is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size
- Missing. The document does not describe a multi-reader, multi-case comparative effectiveness study, nor does it quantify any effect size of AI assistance on human readers. The comparison is primarily at the device level, concluding substantial equivalence based on intended use and technical characteristics.
6. If a standalone (algorithm only without human-in-the-loop performance) was done
- Implied, but details are missing. LiverMultiScan is described as a "standalone software application." The validation mentions "algorithmic testing," suggesting standalone performance testing, but no specific results or study design for this are provided. The "intended use" explicitly states that the results, "when interpreted by a trained physician, yield information that may assist in diagnosis," indicating that the device is intended to be used with human-in-the-loop.
7. The type of ground truth used
- Partially available, but vague. The document mentions "validated with volunteer and phantom scans." This implies that physical phantoms with known properties were used for part of the validation, and "volunteer" scans suggest potentially healthy subjects or subjects with characterized conditions. However, the exact nature of the "ground truth" (e.g., expert consensus, pathology, outcome data) for the volunteer scans or for clinical validation is not specified.
8. The sample size for the training set
- Missing. The documents do not provide any information about the training set size, or even explicitly state that a machine learning model requiring a training set is part of the device (though "algorithmic testing" might imply this).
9. How the ground truth for the training set was established
- Missing. As the training set size and existence are not described, the method for establishing its ground truth is also not mentioned.
Summary of what is available from the document:
- Device Name: LiverMultiScan (LMS)
- Intended Use: Non-invasive liver evaluation by generating, displaying, and reviewing 2D MR medical image data and pixel maps for MR relaxation times from Siemens MAGNETOM Skyra MR Scanners. Provides quantification tools (rulers, ROI) and physical parameters (like triglyceride fat fraction, T1, cT1, T2* mapping) for interpretation by a trained physician to assist in diagnosis.
- Regulatory Class: Class II (892.1000) Product Code: LNH
- Predicate Device: Software syngo MR E11A for the MAGNETOM systems Aera/Skyra (Siemens AG, 510(k) K141977)
- Basis for Equivalence: Substantial equivalence based on similar intended use, technological characteristics (e.g., utilizing DICOM 3.0 compliant MR datasets, supporting multi-slice MR data, providing quantification tools like ROI measurements, generating reports), and performance validated with volunteer and phantom scans.
- Standards Met: IEC 62304, DICOM 3.0
- Compatibility: Compatible with data from Siemens Skyra 3T MR scanners and Microsoft Windows.
- Validation Statement: "LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission."
The provided document serves as a regulatory submission focused on demonstrating substantial equivalence rather than a detailed technical study report. Therefore, it lacks the specific quantitative data points typically found in clinical validation studies.
§ 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.