LiverMultiScan (LMSv4) 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 (LMSv4) 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 (LMSv4) 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 assessments of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may be optionally computed using the DIXON or LMS MOST methods.

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 is a standalone software device. The purpose of the LiverMultiScan 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 such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is subsequently sent to an interpreting clinician at the acquiring site.

LiverMultiScan is not intended to replace the established procedures for the assessment of a patient's liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.

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 liver disease diagnosis, 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.

Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics is to provide imaging information to assist in characterizing tissue in the liver, in addition to existing methods for obtaining information relating to the liver. LiverMultiScan metrics are not intended to replace any existing diagnostic source of information but can be used to identify patients who may benefit most from further evaluation, including biopsy.

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

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

In consequence, the product is considered to have no adverse effect on health since the results represent only a part of the information that the user will utilize for final interpretation. In this regard, LiverMultiScan presents a moderate level of concern with respect to patient safety.

AI/ML Overview

Here's a detailed breakdown 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 acceptance criteria are implicitly defined by the performance test results demonstrating acceptable levels of accuracy, repeatability, and reproducibility. The document states that the observed variations were "well within the prescribed acceptance criteria," but the numerical values for the criteria themselves are not explicitly listed. Instead, the reported performance values are provided.

Metric (Type)	Performance Aspect	Acceptance Criteria (Implicit)	Reported Device Performance (LMSv4)
cT1 (Bench)	Accuracy (1.5T)	Within acceptable range (not explicitly stated, but negative bias in line with literature is acceptable)	-189.5 to -35.11 ms (Consistent with literature-reported underestimation of ground truth T1 using MOLLI techniques)
cT1 (Bench)	Accuracy (3T)	Within acceptable range (not explicitly stated, but negative bias in line with literature is acceptable)	-187.0 to -19.12 ms (Consistent with literature-reported underestimation of ground truth T1 using MOLLI techniques)
T2* (Bench)	Accuracy (1.5T)	Accurate over expected physiological range of values (not explicitly stated numerically)	-0.68 to 0.64 ms (Accurate over the expected physiological range of values)
T2* (Bench)	Accuracy (3T)	Accurate over expected physiological range of values (not explicitly stated numerically)	-0.30 to 0.39 ms (Accurate over the expected physiological range of values)
IDEAL PDFF (Bench)	Accuracy (1.5T)	Accurate over expected physiological range of values (not explicitly stated numerically)	-3.80 to 6.08% (Accurate over the expected physiological range of values)
IDEAL PDFF (Bench)	Accuracy (3T)	Accurate over expected physiological range of values (not explicitly stated numerically)	-1.39 to 5.58% (Accurate over the expected physiological range of values)
cT1 (ROI) (Clinical)	Repeatability	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-43.25 to 26.77 ms (Highly repeatable)
cT1 (Segmentation) (Clinical)	Repeatability	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-40.75 to 25.02 ms (Highly repeatable)
T2* (DIXON) (Clinical)	Repeatability	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-5.21 to 6.01 ms (Highly repeatable)
T2* (MOST) (Clinical)	Repeatability	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-3.17 to 3.25 ms (Highly repeatable)
IDEAL PDFF (ROI) (Clinical)	Repeatability	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-1.48 to 1.42% (Highly repeatable)
IDEAL PDFF (Segmentation) (Clinical)	Repeatability	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-1.31 to 1.34% (Highly repeatable)
cT1 (ROI) (Clinical)	Reproducibility	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-103 to 91.8 ms (Reproducible between scanners and field strengths)
cT1 (Segmentation) (Clinical)	Reproducibility	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-102.3 to 93.69 ms (Reproducible between scanners and field strengths)
T2* (DIXON) (Clinical)	Reproducibility	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-1.74 to 0.35 ms (Reproducible between scanners and field strengths)
T2* (MOST) (Clinical)	Reproducibility	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-2.40 to 2.15 ms (Reproducible between scanners and field strengths)
IDEAL PDFF (ROI) (Clinical)	Reproducibility	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-2.88 to 2.53% (Reproducible between scanners and field strengths)
IDEAL PDFF (Segmentation) (Clinical)	Reproducibility	Well within prescribed acceptance criteria (Limits of Agreement - not numerically specified)	-2.94 to 2.53% (Reproducible between scanners and field strengths)
Operator Variability	Repeatability/Reproducibility	Well within prescribed acceptance criteria (not numerically specified)	Variation introduced by operator measurements (both ROI and segmentation) is well within the prescribed acceptance criteria.

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

Sample Size for Test Set: The document does not explicitly state the numerical sample size for the test set. For the bench testing, it mentions "purpose-built phantoms" and for clinical testing, "in-vivo acquired volunteer data." The number of phantoms or volunteers is not specified.
Data Provenance:
- Bench Testing: Data was acquired from "purpose-built phantoms." The country of origin is not specified, but the applicant (Perspectum Ltd) is based in the UK.
- Clinical Testing: "in-vivo acquired volunteer data" from "volunteers participating in the performance testing were representative of the intended patient population." The country of origin for these volunteers is not specified. The study appears to be prospective for the gathered "volunteer data" in the sense that data was acquired for the purpose of testing, but the details are sparse.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set.

Bench Testing: Ground truth for phantom accuracy was based on the "gold standard" to which the LMSv4 values were compared. This "gold standard" is implied to be the known physical properties or reference measurements of the phantoms.
Clinical Testing: The clinical performance relates to repeatability and reproducibility of the device's measurements themselves, not against a human-established ground truth. Operator variability was assessed, implying trained operators were involved, but their qualifications and number are not detailed beyond "trained internal Perspectum operators."

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned. The performance testing focuses on the device's intrinsic accuracy, repeatability, and reproducibility, rather than agreement with human interpretation that would typically require adjudication.

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

No MRMC comparative effectiveness study was done. The document states: "No clinical investigations or studies were conducted during performance testing of LMSv4." The device is positioned as an "aid to diagnosis" and "not intended to replace any existing diagnostic source of information," suggesting its role is as a tool rather than a standalone diagnostic.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was clearly done. The "Performance Testing - Bench" section directly assesses the "accuracy and precision of device measurements" using phantoms. The "Performance Testing - Clinical" section assesses the "precision of LMSv4 measurements" (repeatability and reproducibility) using volunteer data. While operator variability was assessed, the core measures are of the algorithm's output. The device itself is described as a "post-processing software device" where an "operator uses tools such as automatic liver segmentation and region of interest placement," implying the algorithm performs the quantification and the operator interfaces with it.

7. Type of Ground Truth Used

Bench Testing: The ground truth for accuracy was established using a "gold standard" derived from the "purpose-built phantoms" that contained vials with known relaxation times.
Clinical Testing: For repeatability and reproducibility, the "ground truth" is essentially the device's own consistent measurement across repeated scans, different scanners/field strengths, and different operators. It is not externally validated against pathology or clinical outcomes in this document.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. It focuses solely on the performance testing of the device.

9. How the Ground Truth for the Training Set Was Established

The document does not provide any information regarding the training set or how its ground truth was established, as it does not describe the development or training of the LMSv4 algorithm. The emphasis is on proving substantial equivalence to a predicate device through performance benchmarking.

Summary

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October 2, 2020

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Perspectum LTD % Jaco Jacobs Chief Compliance Officer Gemini One, 5520 John Smith Drive Oxford, Oxfordshire OX4 2LL UNITED KINGDOM

Re: K202170

Trade/Device Name: LiverMultiScan (LMSv4) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: March 13, 2020 Received: August 3, 2020

Dear Jaco Jacobs:

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 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

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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 (QS) 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.

Michael D. O'Hara

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K202170

Device Name LiverMultiScan (LMSv4)

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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Date Prepared:

21st of July 2020

1. Submitter Details

Owner Address:	Perspectum LtdGemini One,5520 John Smith Drive,Oxford Business Park,Oxford,OX4 2LL
Owner/Operator Number:	10056574
Establishment Registration Number:	3014232555
Contact Person:	Dr Jaco Jacobsjaco.jacobs@perspectum.com

+44 (0) 1865 655329

2. Subject and Predicate Device

	Subject Device	Predicate Device
510(k) number	Not known	K190017
Legal Manufacturer	Perspectum Ltd.	Perspectum Diagnostics Ltd.
Owner/Owner Operator	10056574	10056574
Device Name	LiverMultiScan (LMSv4)	LiverMultiScan (LMSv3)
Proprietary/Common	LiverMultiScan	LiverMultiScan
Panel	Radiology	Radiology
Regulation	892.1000	892.1000
Risk Class	Class II	Class II
Product Class code	LNH	LNH
Classification	System, Nuclear MagneticResonance Imaging	System, Nuclear MagneticResonance Imaging

3. Subject Device Description

3.1. General

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

3.2. Sterilization and Shelf Life

LMSv4 is a standalone software device thus it is non-contact, non-invasive and non-sterile. The shelf life of LMSv4 is indefinite as long as the manufacturer continues to support the device. Both sterilization and shelf life characteristics are equivalent of the predicate device.

3.3. Biocompatibility

LMSv4 is a standalone software device thus it is non-contact and non-invasive. No biocompatibility testing was deemed necessary to demonstrate the safety and effectiveness of LMSv4 does not consists of materials that differ from the predicate device.

3.4. Software

LMSv4 was successfully validated and verified against the requirements specification and its intended use. The results from the validation and verification activities, documented in this submission, corroborate that LMSv4 meets the product requirement specifications and intended use, which is deemed to be substantially equivalent to the predicate (see section below).

Validation and verification activities were conducted in a controlled environment and in compliance with IEC 62304:2006, ISO 13485:2016 and 21 CFR 820. LMSv4 is also in compliance with the DICOM standard.

3.5. Electromagnetic and Electrical Safety

LMSv4 is a standalone software device, there are no electrical safety risks associated with the direct use of the LMSv4 device. No electromagnetic or electrical safety testing was deemed necessary to demonstrate the safety and effectiveness of LMSv4.

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Perspectur

4. Subject and Predicate Comparison

Subject and Predicate Device Comparison 4.1.

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

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Perspectum 6

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Perspectum 6

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Perspectum t

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Table 1. Comparison of similar characteristics between the subject and predicate device.

In conclusion, the subject device does not result in any new potential safety risk when compared to the chosen predicate device and performs in accordance with its use characteristics and intended use.

5. Performance Testing

LMSv4 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that LMSv4 is at least as safe and effective as the predicate device and does not introduce any new risks.

Performance Testing - Bench 5.1.

The accuracy and precision of device measurements was assessed using purpose-built phantoms containing vials with different relaxation times corresponding to the physiological range of liver tissue values expected to be seen in-vivo. Accuracy was measured by the proximity of quantified LMSv4 values to the gold standard. The results of which are summarized below:

Metric	Accuracy
	1.5T	3T
cT1	-189.5 to -35.11 ms	-187.0 to -19.12 ms
T2*	-0.68 to 0.64 ms	-0.30 to 0.39 ms
IDEAL PDFF	-3.80 to 6.08%	-1.39 to 5.58%

Table 2. Pooled performance testing - bench

The MOLLI-based T1 measurement produced by LMSv4 is consistent with the literature-reported . underestimation of ground truth T1 using MOLLI techniques 34
. LMSv4 measurement of T2*is accurate over the expected physiological range of values
LMSv4 measurement of PDFF is accurate over the expected physiological range of values o

5.2. Performance Testing - Clinical

To assess the precision of LMSv4 measurements across supported scanners in-vivo acquired 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. The results of which are summarized below:

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Metric	Repeatability	Reproducibility
	Limits of Agreement	Limits of Agreement
cT1 (ROI)	-43.25 to 26.77 ms	-103 to 91.8 ms
cT1 (Segmentation)	-40.75 to 25.02 ms	-102.3 to 93.69 ms
T2* (DIXON)	-5.21 to 6.01 ms	-1.74 to 0.35 ms
T2* (MOST)	-3.17 to 3.25 ms	-2.40 to 2.15 ms
IDEAL PDFF (ROI)	-1.48 to 1.42%	-2.88 to 2.53%
IDEAL PDFF (Segmentation)	-1.31 to 1.34%	-2.94 to 2.53%

Table 3. Pooled performance testing - clinical

LMSv4 measurements of cT1, T2* and PDFF are highly repeatable .
LMSv4 measurements of cT1, T2* and PDFF are reproducible between scanners and field strengths .
The variation introduced by operator measurements with both ROI placement and segmentation method is well . within the prescribed acceptance criteria.

5.3. Clinical Investigation

No clinical investigations or studies were conducted during performance testing of LMSv4.

6. Conclusion

The subject device is substantially equivalent to the predicate device, both regulated under regulation 21 CFR 892.1000. Substantial equivalence is based on the following observations:

. The indications for use and intended uses of both the subject device and predicate device are substantially equivalent.
The subject and predicate devices are both software applications which facilitate the import and visualization of • MR data sets to visualise and enable quantification of physiological characteristics in the liver to provide measurements.
The subject and predicate devices both support tools and features to derive measurements from MR images . and parametric maps of tissue characteristics.
The subject and predicate device facilitate the creation of a medical report containing the images and analysis . output derived from quantification of liver tissue parameters intended to be interpreted by a trained clinician.
. Both the subject and predicate devices are designed to run on general-purpose computing hardware and intended to be used in the same environment.
Performance testing and risk management demonstrates that the subject device performs at least as safely and . effectively as the proposed predicate device and supports the determination of substantial equivalence.

In conclusion, the subject device does not result in any new potential safety risks when compared to the chosen predicate device and performs in accordance with its use characteristics and intended use.

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References

1. Reeder, S. B. et al. Iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL): Application with fast spin-echo imaging. Magn. Reson. Med. 54, 636–644 (2005).
1. Dixon, W. T. Simple proton spectroscopic imaging. Radiology 153, 189–194 (1984).
1. Piechnik, S. K. et al. Shortened Modified Look-Locker Inversion recovery (ShMOLLI) for clinical myocardial T1mapping at 1.5 and 3 T within a 9 heartbeat breathhold. J. Cardiovasc. Magn. Reson. 12, 69 (2010).
1. Puntmann, V. O. et al. Are T1 values to characterize myocardial tissue equivalent between various sequences: comparison of MOLLI, shMOLLI, 3'5-MOLLI and SASHA. J. Cardiovasc. Magn. Reson. 15, E18 (2013).

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.

Comparison of Subject and Predicate Device
Characteristic	LMSv4 (Subject device)	LMSv3 (Predicate device)
Intended Useand Indicationsfor Use	"LiverMultiScan (LMSv4) is indicated for use asa magnetic resonance diagnostic devicesoftware application for non-invasive liverevaluation that enables the generation, displayand review of 2D magnetic resonance medicalimage data and pixel maps for MR relaxationtimes.	"LiverMultiScan (LMSv3) is indicated for use asa magnetic resonance diagnostic devicesoftware application for non-invasive liverevaluation that enables the generation, displayand review of 2D magnetic resonance medicalimage data and pixel maps for MR relaxationtimes.
	LiverMultiScan (LMSv4) is designed to utilizeDICOM 3.0 compliant magnetic resonanceimage datasets, acquired from compatible MRsystems, to display the internal structure of theabdomen including the liver. Other physicalparameters derived from the images may alsobe produced.	LiverMultiScan (LMSv3) is designed to utilizeDICOM 3.0 compliant magnetic resonanceimage datasets, acquired from compatible MRsystems, to display the internal structure ofthe abdomen including the liver. Otherphysical parameters derived from the imagesmay also be produced.
	LiverMultiScan (LMSv4) provides a number oftools, such as automated liver segmentationand region of interest (ROI) placements, to beused for the assessment of selected regions ofan image. Quantitative assessments ofselected regions include the determination oftriglyceride fat fraction in the liver (PDFF), T2*and iron-corrected T1 (cT1) measurements.	LiverMultiScan (LMSv3) provides a number oftools, such as automated liver segmentationand region of interest (ROI) placements, to beused for the assessment of selected regions ofan image. Quantitative assessments ofselected regions include the determination oftriglyceride fat fraction in the liver (PDFF), T2*and iron-corrected T1 (cT1) measurements.
	T2* may be optionally computed using theDIXON or LMS MOST methods.	PDFF may optionally be computed using theLMS IDEAL or three-point DIXONmethodology.
	These images and the physical parametersderived from the images, when interpreted bya trained clinician, yield information that mayassist in diagnosis."	These images and the physical parametersderived from the images, when interpreted bya trained clinician, yield information that mayassist in diagnosis."
Target	Patients suitable to undergo an MRI scan and	Patients suitable to undergo an MRI scan and
PopulationDevice User	not contra-indicated for MRI.Trained Perspectum operator	not contra-indicated for MRI.Trained Perspectum operator
Report User	An interpreting clinician or healthcarepractitioner.	An interpreting clinician or healthcarepractitioner.
Device UseEnvironment	Installation of LMSv4 is controlled and installedon general purpose workstations atPerspectum's image analysis centre, byspecialist members of staff.	Installation of LMSv3 is controlled andinstalled on general purpose workstations atPerspectum's image analysis centre byspecialist members of staff.
Comparison of Subject and Predicate Device
Characteristic	LMSv4 (Subject device)	LMSv3 (Predicate device)
Clinical Setting	LMSv4 is a standalone software device that isintended to be installed on general useworkstations at Perspectum's image analysiscentre. The intended device users will log on tothe workstations, access the device, and usethe device on general-use HD monitors.	LMSv3 is a standalone software device that isintended to be installed on general useworkstations at Perspectum's image analysiscentre. The intended device users will log onto the workstations, access the device, anduse the device on general-use HD monitors.
	LMSv4 is a post-processing software, theintended device users are trained internalPerspectum operators. Operators use LMS toconduct quantitative analysis of liver tissuecharacteristics to produce a report.	LMSv3 is a post-processing software, theintended device users are trained internalPerspectum operators. Operators use LMS toconduct quantitative analysis of liver tissuecharacteristics to produce a report.
	The end-users for the output from the device,the pdf report, are clinicians who receive andinterpret LMSv4 reports through the QAS.	The end-users for the output from the device,the pdf report, are clinicians who receive andinterpret LMSv3 reports through the QAS.
AnatomicalLocation	Abdomen, Liver	Abdomen, Liver
EnergyConsiderations	Software only application. The device, astandalone software application, does notdeliver, monitor or depend on energydelivered to or from patients.	Software only application. The device, astandalone software application, does notdeliver, monitor or depend on energydelivered to or from patients.
Design: Purpose	LMS is a standalone software application that	LMS is a standalone software application that
	imports MR data sets encompassing theabdomen, including the liver. Visualisation anddisplay of 2D multi-slice, spin-echo MR datacan be analysed, and quantitative metrics oftissue characteristics are then reported.Datasets imported into LMS are DICOM 3.0compliant, reported metrics are independentof the MRI equipment vendor.	imports MR data sets encompassing theabdomen, including the liver. Visualisationand display of 2D multi-slice, spin-echo MRdata can be analysed, and quantitativemetrics of tissue characteristics are thenreported.Datasets imported into LMS are DICOM 3.0compliant, reported metrics are independent
Design: Tools	Allows for the visualisation via parametricmaps and quantification of metrics (cT1, T2*and PDFF) from liver tissue and exportation ofresults & images to a deliverable report.LMSv4 allows for:	of the MRI equipment vendor.Allows for the visualisation via parametricmaps and quantification of metrics (cT1, T2*and PDFF) from liver tissue and exportation ofresults & images to a deliverable report.LMSv3 allows for:
	cT1Full segmentation of the outer livercontour and liver vasculature of the cT1parametric map. Interquartile Range (IQR)and median metrics are reported from thesegmentation.	cT1Full segmentation of the outer livercontour and liver vasculature of the cT1parametric map.Interquartile Range (IQR) and medianmetrics are reported from thesegmentation.
Comparison of Subject and Predicate Device
Characteristic	LMSv4 (Subject device)	LMSv3 (Predicate device)
	ROI placed method on the cT1 map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices.	ROI placed method on the cT1 map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices.
	T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. T2* parametric maps are calculated from the MOST method or the three-point DIXON method.	T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. T2* parametric maps are calculated from the three-point DIXON method.
	PDFF Full liver segmentation of the PDFF parametric map where IQR and median metrics are reported from the segmentation. ROI placed method on the PDFF map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. PDFF parametric maps are calculated using the LMS IDEAL method 1	PDFF Full liver segmentation of the PDFF parametric map where IQR and median metrics are reported from the segmentation. ROI placed method on the PDFF map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. PDFF parametric maps can be calculated using either the LMS IDEAL method 1 or the three-point DIXON method 2
Design: MRRelaxometry	T1, iron-corrected T1 (cT1) and T2* mapping.	T1, iron-corrected T1 (cT1) and T2* mapping.
Design: Liver FatQuantification	Utilizes MR images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat using the LMS IDEAL method.	Utilizes MR images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat using either the LMS IDEAL method or three-point DIXON method.
Design: LiverSegmentation	LMSv4 supports automatic multi-slice full liver segmentation of the cT1 and PDFF parametric map, use of this functionality is at the discretion of the operator instead or in combination with the ROI based method.The cT1 segmented liver is presented in colour level window, while the rest of the cT1 image is presented in greyscale level window with ducts and liver vasculature excluded from the segmented volume.	LMSv3 supports automatic multi-slice full liver segmentation of the cT1 and PDFF parametric map, use of this functionality is at the discretion of the operator instead or in combination with the ROI based method.The cT1 segmented liver is presented in colour level window, while the rest of the cT1 image is presented in greyscale level window with ducts and liver vasculature excluded from the segmented volume.
	Comparison of Subject and Predicate Device
Characteristic	LMSv4 (Subject device)	LMSv3 (Predicate device)
Design: Regionsof Interest (ROI)	Median and interquartile range measurementscreated from a cross sectional slice of livertissue. For each parametric map, statisticsfrom multiple Regions of Interest (ROIs) –potentially placed across multiple slices - aresummarised.	Median and interquartile range measurementscreated from a cross sectional slice of livertissue. For each parametric map, statisticsfrom multiple Regions of Interest (ROIs) –potentially placed across multiple slices – aresummarised.
Design:ParametricMaps	Iron corrected T1 (cT1), T2* and ProtonDensity Fat Fraction (PDFF) parametric mapscan be created from all supported scanners.PDFF is quantified using the LMS IDEALmethod. Parametric maps of T2* may beoptionally be computed using either thethree-point DIXON method or the LMS MOSTmethod.	Iron corrected T1 (cT1), T2* and ProtonDensity Fat Fraction (PDFF) parametric mapscan be created from all supported scanners.PDFF is quantified using the LMS IDEALmethod or the three-point DIXON method.
Design:Visualisation	Numerous views within the LMSv4 interfacecan be used to assist in analysis, Iron-corrected T1 (cT1), T2* and triglyceride fat(also known as Proton Density Fat Fraction(PDFF)) parametric maps can be created fromall supported scanners. R² maps can also beutilised to assess the quality of the map fitting.Iron- corrected T1 (cT1) displayed using LMSv4colourmap, designed to have maximumcontrast on liver parenchymal tissue.	Numerous views within the LMSv4 interfacecan be used to assist in analysis, ironcorrected T1 (cT1), T2* and triglyceride fat(also known as Proton Density Fat Fraction(PDFF)) parametric maps can be created fromall supported scanners.Iron corrected T1 (cT1) displayed using theLMSv3 colourmap, designed to have maximumcontrast on liver parenchymal tissue.
Design:SupportedModalities	DICOM 3.0 compliant MR data from supportedMRI scanners.	DICOM 3.0 compliant MR data from supportedMRI scanners.
Design: Report	Quantified metrics and images derived fromthe analysis conducted of liver tissuecharacteristic on parametric maps are collatedinto a report for evaluation and interpretationby a clinician.	Quantified metrics and images derived fromthe analysis conducted of liver tissuecharacteristic on parametric maps arecollated into a report for evaluation andinterpretation by a clinician.
Compatibilitywith theenvironment	Installation of LMSv4 is controlled and isinstalled on general purpose workstations thatmeet the minimum technical requirements atPerspectum's image analysis centre byspecialist members of staff.	Installation of LMSv3 is controlled and isinstalled on general purpose workstationsthat meet the minimum technicalrequirements at PD's image analysis centre byspecialist members of staff.
Performance	Device performance was assessed withpurpose-built phantoms and in-vivo acquireddata from volunteers covering a range ofphysiological values for cT1, T2* and PDFF.	Device performance was assessed withpurpose-built phantoms and in-vivo acquireddata from volunteers covering a range ofphysiological values for cT1, T2* and PDFF.
Supported MRISystems	Validated across all listed supportedmanufacturers and field strengths.	Validated across all listed supportedmanufacturers and field strengths.
Standards	IEC 62304, IEC 62366, DICOM 3.0, ISO 14971,ISO 13485	IEC 62304, IEC 62366, DICOM 3.0, ISO 14971,ISO 13485
Comparison of Subject and Predicate Device
Characteristic	LMSv4 (Subject device)	LMSv3 (Predicate device)
System/Operating System	Mac OS	Mac OS
Materials	Not applicable, standalone software.	Not applicable, standalone software.
Biocompatibility	Not applicable, standalone software.	Not applicable, standalone software.
Sterility	Not applicable, standalone software.	Not applicable, standalone software.
Electrical Safety	Not applicable, standalone software.	Not applicable, standalone software.
MechanicalSafety	Not applicable, standalone software.	Not applicable, standalone software.
Chemical Safety	Not applicable, standalone software.	Not applicable, standalone software.
Thermal Safety	Not applicable, standalone software.	Not applicable, standalone software.
Radiation Safety	Not applicable, standalone software.	Not applicable, standalone software.