LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic 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.

LMSv5 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.

LMSv5 provides several 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 includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.

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

Device Description

LiverMultiScan v5 (LMSv5) is a standalone software device. The LiverMultiScan v5 device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit).

LiverMultiScan is a post-processing software device, a trained operator uses tools within the device interface to quantify liver tissue characteristics from parametric maps. LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver. A summary report from the analysis conducted is generated for interpretation by a clinician.

LiverMultiScan v5 is not intended to replace the established procedures for the assessment of a patient's liver health by a clinician, providing many opportunities for competent human intervention in the clinical care of patients.

The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of clinical care, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation.

Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision.

LiverMultiScan v5 is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan v5 is an aid to diagnosis and treatment decisions remain the responsibility of the clinician.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for LiverMultiScan v5 (LMSv5) based on the provided text, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary document does not explicitly list quantitative acceptance criteria in a dedicated table format. Instead, it states that "All product specifications were verified and the overall ability of the product to meet user needs was validated." and "The accuracy and precision of device measurements was assessed using purpose-built phantoms...". It also mentions "The performance testing conducted demonstrates that LiverMultiScan v5 is at least as safe and effective as the predicate devices."

While specific numerical acceptance criteria (e.g., "PDFF accuracy must be within X%", "LIC precision must be within Y%") are not detailed in this public document, the general acceptance can be inferred from the statement that the device meets safety and effectiveness standards comparable to its predicates. The performance claims are therefore that the device provides accurate and precise measurements of liver triglyceride fat fraction (PDFF), T2*, Liver Iron Concentration (LIC), and iron-corrected T1 (cT1), comparable to or exceeding its predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Accuracy and precision of PDFF measurements	Assessed using purpose-built phantoms, revealing accuracy and precision corresponding to physiological ranges. In-vivo volunteer data also used to assess precision across supported scanners.
Accuracy and precision of T2* measurements	Assessed using purpose-built phantoms, revealing accuracy and precision corresponding to physiological ranges. In-vivo volunteer data also used to assess precision across supported scanners.
Accuracy and precision of LIC measurements	Assessed using purpose-built phantoms, revealing accuracy and precision corresponding to physiological ranges. In-vivo volunteer data also used to assess precision across supported scanners. (Note: LMSv5 introduces LIC quantification, which was not available in the primary predicate LMSv4, but was available in the secondary predicate FerriScan. The performance is assessed to be at least as safe and effective as the predicates.)
Accuracy and precision of cT1 measurements	Assessed using purpose-built phantoms, revealing accuracy and precision corresponding to physiological ranges. In-vivo volunteer data also used to assess precision across supported scanners.
Inter and Intra-operator variability	Assessed. (Specific metrics not provided in this document).
Functionality (installation, licensing, labeling, features)	Met design requirements.
Overall safety and effectiveness	Demonstrated to be at least as safe and effective as the predicate devices. Differences from predicates do not result in a new intended use or raise new questions of safety and effectiveness.
Artifact detection and delineation (new feature in LMSv5)	Automatically detects artifacts and delineates them on parametric maps, recommending slices for quantitative output. (Functionality and impact on quantification/interpretation assessed).
Compatibility with DICOM 3.0 compliant MR image datasets	Designed to utilize them.
Independence of reported metrics from MRI equipment vendor	Datasets imported into LiverMultiScan (LMSv5) are DICOM 3.0 compliant, reported metrics are independent of the MRI equipment vendor.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document mentions "in-vivo volunteer data was used" for assessing precision across supported scanners and for inter/intra-operator variability. It also refers to "purpose-built phantoms" for accuracy and precision of device measurements. Specific numerical sample sizes for either phantom or in-vivo data are not provided in this summary document.
Data Provenance: Not explicitly stated from which country the "in-vivo volunteer data" originated. It is generally understood that studies supporting medical device submissions to the FDA can involve multinational data, but this document does not specify. The data would be prospective if volunteers were recruited and scanned specifically for this validation, or retrospective if existing de-identified patient data was used. The document does not clarify this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. For quantitative MRI biomarkers like PDFF, T2*, cT1, and LIC, ground truth is typically established through direct physical measurements (e.g., chemical extraction for fat, histology/biopsy for iron/fibrosis, though biopsy has limitations) or well-validated reference standards (phantoms or highly accurate established MRI methods). The document mentions "purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values" were used for accuracy and precision, implying these phantoms served as a form of ground truth for those measurements.

4. Adjudication method for the test set

The document does not describe any expert adjudication methods (e.g., 2+1, 3+1) for the test set within this summary. For this type of quantitative imaging device, the focus is more on technical accuracy and precision against established physical or biological references rather than subjective expert consensus on image interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not report an MRMC comparative effectiveness study where human readers' performance with and without AI assistance (LMSv5) was evaluated. The device is described as "post-processing software" that provides "additional diagnostic input" and is "an aid to diagnosis." It includes "automatic processing functionality based on machine-learning to assist in the quantification of metrics... such as automatic artefact detection and automatic segmentation of the liver." However, the study described focuses on the device's standalone performance (accuracy, precision, variability) and not on its impact on human reader performance in a controlled comparative setting.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The testing described focuses on the device's intrinsic capabilities:

"The accuracy and precision of device measurements was assessed using purpose-built phantoms..."
"To assess the precision of LiverMultiScan v5 measurements across supported scanners, in-vivo volunteer data was used."
"Inter and intra operator variability was also assessed." (While this involves human operators, it assesses the device's consistency under different human interactions, not the human's diagnostic performance).
The device is a "standalone software device" and "All operations are directly controlled by the LiverMultiScan device."

This indicates that the technical performance of the algorithm itself, in generating the quantitative metrics (PDFF, T2*, LIC, cT1), was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth described in this summary are:

Physical Phantoms: "purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values expected to be seen in-vivo" were used to assess the accuracy and precision of measurements. This provides a quantifiable, objective ground truth for the relaxation times and component fractions (like fat).
For LIC, the device "uses the measured T2* value and uses them to characterise iron loading in the liver which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentration in vivo." This implies the ground truth for establishing that calibration curve would likely have been against biopsy-derived liver iron concentration data or other highly validated reference methods in earlier studies (though not explicitly stated for this particular submission's testing itself, it's the basis for LIC quantification).

8. The sample size for the training set

The document does not specify the sample size used for the training set. It mentions that LMSv5 includes "automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver." This clearly indicates machine learning was used, and thus a training set was necessary. However, the size and characteristics of that training set are not included in this 510(k) summary.

9. How the ground truth for the training set was established

The document does not detail how the ground truth for the training set (used for machine learning components like automated segmentation and artifact detection) was established. Typically, for such features, ground truth would be established through:

Expert manual segmentation/annotation: Radiologists or trained medical image analysts would manually delineate liver boundaries and artifacts on a large dataset of MR images.
Consensus from multiple experts: To reduce individual bias, several experts might review and agree upon segmentations or artifact labeling.

However, these specifics are omitted from this summary.

Summary

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September 6, 2022

Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs Gemini One 5520 John Smith Drive Oxford, Oxfordshire OX 2LL UNITED KINGDOM

Re: K213960

Trade/Device Name: LiverMultiScan v5 (LMSv5) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: July 26, 2022 Received: July 26, 2022

Dear Ioan Wigley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213960

Device Name LiverMultiScan v5

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Dect

Date Prepared:

01 September 2022

K213960

Submitter Details

Owner Address:

Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL +44 (0) 1865 655329

Owner/Operator Number:	10056574
Establishment Registration Number:	3014232555
Contact Person:	loan Wigleyloan.Wigley@perspectum.com+44 (0) 1865 655329

Subject and Predicate Devices

	Subject Device	Primary Predicate Device	Secondary Predicate Device
510(k) number	Not known	K202170	K043271
Legal Manufacturer	Perspectum Ltd.	Perspectum Ltd.	Inner Vision Biometrics Pty
Owner/Owner Operator	10056574	10056574	/
Device Name	LiverMultiScan v5.0.0	LiverMultiScan v4.0.0	R2-MRI Analysis System(FerriScan)
Proprietary/Common	LiverMultiScan, LMSv5, LMS	LiverMultiScan, LMSv4, LMS	FerriScan
Panel	Radiology	Radiology	Radiology
Regulation	892.1000	892.1000	892.1000
Risk Class	Class II	Class II	Class II
Product Class code	LNH	LNH	LNH
Classification	System, Nuclear MagneticResonance Imaging	System, Nuclear MagneticResonance Imaging	System, Nuclear MagneticResonance Imaging

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Subject Device

General Description

Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision.

Intended Use and Indications for Use

LiverMultiScan v5 (LMSv5) 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.

LMSv5 provides several 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 includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LlC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.

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

Indications and contraindications

LiverMultiScan is indicated for use where MRI is not contraindicated.

Contraindications

LiverMultiScan is indicated for use where MRI is not contraindicated.

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Intended Conditions

LiverMultiScan is not intended to be used for use on any specific disease or condition, but the information provided in the report, when interpreted by a licensed physician, may benefit the clinical management, including diagnosis and monitoring of patients.

Standalone Software

LiverMultiScan is a post-processing software device. All operations are directly controlled by the LiverMultiScan device. LiverMultiScan does not control other firmware or software outside of the device

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Subject and Predicate Comparison

The following characteristics were compared between the predicate device in order to demonstrate substantial equivalence.

Characteristic	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System(FerriScan) (SecondaryPredicate)
IntendedUse	LiverMultiScan v5 (LMSv5) isindicated for use as a magneticresonance diagnostic device softwareapplication for non-invasive liverevaluation that enables thegeneration, display and review of 2Dmagnetic resonance medical imagedata and pixel maps for MR relaxationtimes.LMSv5 is designed to utilize DICOM3.0 compliant magnetic resonanceimage datasets, acquired fromcompatible MR Systems, to displaythe internal structure of the abdomenincluding the liver. Other physicalparameters derived from the imagesmay also be produced.	LiverMultiScan (LMSv4) is indicatedfor use as a magnetic resonancediagnostic device softwareapplication for non-invasive liverevaluation that enables thegeneration, display and review of 2Dmagnetic resonance medical imagedata and pixel maps for MR relaxationtimes.LiverMultiScan (LMSv4) is designed toutilize DICOM 3.0 compliant magneticresonance image datasets, acquiredfrom compatible MR systems, todisplay the internal structure of theabdomen including the liver. Otherphysical parameters derived from theimages may also be produced.	For the analysis of multi-slice, spin-echo MRI datasets of the liver for themeasurement of liver R2and liver iron concentration.
Characteristic	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System(FerriScan) (SecondaryPredicate)
	LMSv5 provides several tools, such asautomated liver segmentation andregion of interest (ROI) placements,to be used for the assessment ofselected regions of an image.Quantitative assessment of selectedregions includes the determination oftriglyceride fat fraction in the liver(PDFF), T2*, LIC (Liver IronConcentration) and iron corrected T1(cT1) measurements.	LiverMultiScan (LMSv4) provides anumber of tools, such as automatedliver segmentation and region ofinterest (ROI) placements, to be usedfor the assessment of selectedregions of an image. Quantitativeassessments of selected regionsinclude the determination oftriglyceride fat fraction in the liver(PDFF), T2* and iron-corrected T1(cT1) measurements. T2* may beoptionally computed using the DIXONor LMS MOST methods.
	These images and the physicalparameters derived from the images,when interpreted by a trainedclinician, yield information that mayassist in diagnosis.	These images and the physicalparameters derived from the images,when interpreted by a trainedclinician, yield information that mayassist in diagnosis.
Indicationsfor Use	Same as intended use	Same as intended use	The R2-MRI Analysis Systemis an accessory diagnosticdevice to MRI scanners andis intended for diagnosticuse to present images thatreflect the magneticresonance spectra for thedetermination of iron on theliver.
Characteristic	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System(FerriScan) (SecondaryPredicate)
TargetPopulation	Patients suitable to undergo an MRIscan and not contra-indicated for MRI	Patients suitable to undergo an MRIscan and not contra-indicated for MRI	Patients suitable to undergoan MRI scan and not contra-indicated for MRI
Device User	Trained Perspectum internal operator	Trained Perspectum internal operator	Resonance Health's trainedanalyst
Report User	An interpreting clinician or healthcarepractitioner	An interpreting clinician or healthcarepractitioner	An interpreting clinician orhealthcare practitioner
Device UseEnvironment	Installation of LiverMultiScan v5 iscontrolled and is installed on generalpurpose workstations that meet theminimum technical requirements atPerspectum's image analysis centreby specialist members of staff.	Installation of LMSv4 is controlled andis installed on general purposeworkstations that meet the minimumtechnical requirements atPerspectum's image analysis centreby specialist members of staff.	Image analysis and LICreporting is performed at acentral ISO 13485 certifiedService Centre. Hostingplatform is resonancehealth's internal server.
ClinicalSetting	LiverMultiScan v5 is a standalonepost-processing software device thatis intended to be installed on generaluse workstations at Perspectum'simage analysis centre.Operators use LMSv5 to conductquantitative analysis of liver tissuecharacteristics to produce a report.The end-users for the output fromthe device, the report, are clinicianswho receive and interpretLiverMultiScan (LMSv5) reports.	LMSv4 is a standalone post-processing software device that isintended to be installed on generaluse workstations at Perspectum'simage analysis centre.Operators use LMS to conductquantitative analysis of liver tissuecharacteristics to produce a report.The end-users for the output fromthe device, the report, are clinicianswho receive and interpret LMSv4reports.	FerriScan is a standalonesoftware tool that isintended to be used byResonance Health's trainedanalyst, FerriScan is installedand runs on the ResonanceHealth's internal server.The report result is overseenby the radiologist and thefinal decision for clinicalmanagement of the patientis made by their treatingclinician.
AnatomicalLocation	Abdomen, including the liver	Abdomen, including the Liver	Abdomen, including theLiver.
Characteristic	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System(FerriScan) (SecondaryPredicate)
Energy	LiverMultiScan v5 is a standalonesoftware application, it does notdeliver, monitor or depend on energydelivered to or from patients.	LMS is a standalone softwareapplication, it does not deliver,monitor or depend on energydelivered to or from patients.	FerriScan is a standalonesoftware application. It doesnot deliver, monitor ordepend on energy deliveredto or from patients.
Design:Purpose	LiverMultiScan v5 is a standalonesoftware application that imports MRdata sets encompassing theabdomen, including the liver.Visualisation and display of 2D multi-slice, spin-echo MR data can beanalysed and quantitative metrics oftissue characteristics are thenreported.Datasets imported intoLiverMultiScan (LMSv5) are DICOM3.0 compliant, reported metrics areindependent of the MRI equipmentvendor.	LMS is a standalone softwareapplication that imports MR data setsencompassing the abdomen,including the liver. Visualisation anddisplay of 2D multi-slice, spin-echoMR data can be analysed andquantitative metrics of tissuecharacteristics are then reported.Datasets imported into LMS areDICOM 3.0 compliant, reportedmetrics are independent of the MRIequipment vendor.	FerriScan is intended for:• Supporting clinicaldiagnoses about thestatus of liver ironconcentration.• Supporting thesubsequent clinicaldecision-makingprocesses.• Supporting the use inclinical research trials,directed at studyingchanges in liver ironconcentration as aresult of interventions.• It contains an imageviewer for importingDICOM images,browsing throughpatient datasets,viewing images andperforming region ofinterest analysis
Characteristi	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System
c			(FerriScan) (SecondaryPredicate)
Design: Tools	Allows for the visualisation viaparametric maps and quantificationof metrics (cT1, LIC and PDFF) fromliver tissue and exportation of results& images to a deliverable report.	Allows for the visualisation viaparametric maps and quantificationof metrics (cT1, T2* and PDFF) fromliver tissue and exportation of results& images to a deliverable report.	Allows for the visualisationof images that reflect themagnetic resonance spectrafor the determination ofiron on the liver. It contains
	Quantification is through either fullsegmentation of the outer livercontour and liver vasculature ormanual placement of ROI's on theparametric maps. IQR and medianmetrics are reported from thesegmentation/ROI quantification.automatically detects artefacts on theand are delineated on the parametricmap computed images as well asrecommends slices to be used as the	Quantification is through either fullsegmentation of the outer livercontour and liver vasculature ormanual placement of ROI's on theparametric maps. IQR and medianmetrics are reported from thesegmentation/ROI quantification.	an image viewer for• importing DICOMimages,• browsing throughpatient datasets,• viewing images andperforming ROI analysis.
Design: MRRelaxometry	quantitative output of the device.T1, iron corrected T1 (cT1) mappingand LIC	T1, iron corrected T1 (cT1) and T2*mapping	R2 (Signal Decay Rate)mapping
Design: LiverFatQuantification	Utilizes MR images that exploit thedifference in resonance frequenciesbetween hydrogen nuclei in waterand triglyceride fat using theLiverMultiScan v5 IDEAL method.	Utilizes MR images that exploit thedifference in resonance frequenciesbetween hydrogen nuclei in waterand triglyceride fat using the LMSIDEAL method.	N/A
Design:ParametricMaps	Iron corrected T1 (cT1), ProtonDensity Fat Fraction (PDFF) and LICparametric maps can be created fromall supported scanners.	Iron corrected T1 (cT1), T2* andProton Density Fat Fraction (PDFF)parametric maps can be created fromall supported scanners.	FerriScan calculates thesignal decay rate (R2) that isused to characterise ironloading in the liver. Itproduces an output report
Characteristic	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System(FerriScan) (SecondaryPredicate)
	It is possible to use the LIC maps andknowledge of the measurements andthe scanner field strength to correctfor signal changes related to irondeposits, producing a cT1 map. ThecT1 map eliminates the effects ofelevated iron from the T1measurement (3) and standardizesfor the fat signal across scannermanufacturers.PDFF is quantified using the LMSIDEAL method. Parametric maps ofLIC are quantified using the LMSMOST method.LMSv5 uses the measured T2* valueand uses them to characterise ironloading in the liver which is thentransformed by a defined calibrationcurve to provide a quantitativemeasure of liver iron concentration invivo. LMSv5 presents images thatreflect the magnetic resonancespectra for iron determination on theliver.	It is possible to use the T2* and PDFFmaps and knowledge of the T2* andPDFF measurements and the scannerfield strength to correct for signalchanges related to iron deposits,producing a cT1 map. The cT1 mapeliminates the effects of elevated ironfrom the T1 measurement (3) andstandardizes for the fat signal acrossscanner manufacturers.PDFF is quantified using the LMSIDEAL method. Parametric maps ofT2* may optionally be computedusing either the three-point DIXONmethod or the LMS MOST method.	comprising R2 which istransformed by a definedcalibration curve into aquantitative measure of liveriron concentration in vivo.FerriScan presents imagesthat reflect the magneticresonance spectra for irondetermination on the liver.
Design:Visualisation	Numerous views within theLiverMultiScan v5 interface can beused to assist in analysis of Ironcorrected T1 (cT1), triglyceride fat(also known as Proton Density FatFraction (PDFF)) and LIC parametric	Numerous views within the LMSv4interface can be used to assist inanalysis, Iron-corrected T1 (cT1), T2*and triglyceride fat (also known asProton Density Fat Fraction (PDFF))parametric maps can be created from	Visualisation of multi-slice,spin-echo MRI data setsencompassing theabdomen.Software tool calculates thesignal decay rate (R2) that is
Characteristic	LMSv5 (Subject device)	LMSv4 (Primary Predicate Device)	R2-MRI Analysis System(FerriScan) (SecondaryPredicate)
	maps can be created from allsupported scanners.Parametric maps displayed using theLMSv5 colourmap, designed to havemaximum contrast on liverparenchymal tissue.	all supported scanners. R2 maps canalso be utilised to assess the qualityof the map fitting.Iron- corrected T1 (cT1) displayedusing LMSv4 colourmap, designed tohave maximum contrast on liverparenchymal tissue.	used to characterise ironloading in the liver, which isthen transformed by adefined calibration curve toprovide a quantitativemeasure of liver ironconcentration in vivo.LIC is displayed on a mapand histogram within theFerriScan LIC report.
Design:SupportedModalities	DICOM 3.0 compliant MR data from	DICOM 3.0 compliant MR data from	DICOM Image Format.Functionality independentof MRI equipment vendor.
	supported MRI scanners.	supported MRI scanners.

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Differences between subject and predicate devices

The LMSv5 device offers additional quantification tools in its interface that are not available in the primary . predicate device, LMSv4. LMSv5 automatically detects artefacts on the and are delineated on the parametric map computed images as well as recommends slices to be used as the quantitative output of the device. Artefact areas are overlayed on the parametric maps to assist in quantification and interpretation.
. LMSv5 uses the measured T2* values to characterise iron loading in the liver which is transformed by a defined calibration curve to provide a quantitative measure of liver iron concentration (LIC) in vivo. LMSv5 presents images that reflect the magnetic resonance spectra for iron determination on the liver. The primary predicate device does not offer quantification of LIC. However, the secondary predicate, R2-MRI Analysis System (FerriScan) also produces an outputted report comprising measured R2 values that are transformed by a defined calibration curve into a quantitative measure of liver iron concentration.

Software and Performance Testing

All product specifications were verified and the overall ability of the product to meet user needs was validated. Testing was performed according to internal company procedures. Software testing and validation were conducted according to written test protocols established before testing was conducted. Software verification and validation testing were conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for LiverMultiScan v5 is Moderate, as per FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This device does not control a life supporting or life-sustaining device, nor does it control the delivery of a potentially harmful energy. This device does not control the delivery of treatment, and it does not provide diagnostic information, nor does it provide any vital signs monitoring. The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented.

Bench testing included functional verification to ensure software installation, licensing, labeling, and feature functionality all met design requirements. The accuracy and precision of device measurements was assessed using purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values expected to be seen in-vivo. To assess the precision of LiverMultiScan v5 measurements across supported scanners, in-vivo volunteer data was used. Volunteers participating in the performance testing were representative of the intended patient population. Inter and intra operator variability was also assessed.

LiverMultiScan v5 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that LiverMultiScan v5 is at least as safe and effective as the predicate devices.

Conclusion

LiverMultiScan v5 has the same intended use and similar technological characteristics as the predicate devices, LiverMultiScan v4 and Ferriscan. Software and Performance testing corroborate the differences between the subject device and the predicates do not result in a new intended use and do not raise any questions of safety and effectiveness. It can be concluded that LiverMultiScan v5 is substantially equivalent to the listed predicate devices.

Regulation Number and Section

§ 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.