Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The summary mentions "automated liver segmentation and region of interest (ROI) placements," which could potentially utilize AI/ML, but the description does not explicitly state that AI/ML is used for this or any other function. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".

Therapeutic

No.
The device is a software application for noninvasive liver evaluation that assists in diagnosis by processing and displaying MR image data, not for treating or rehabilitating patients.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the device yields information that may assist in diagnosis when interpreted by a trained clinician.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that LiverMultiScan (LMSv3) is a "standalone software application" that runs on "general-purpose workstations." It processes existing MR image data and does not include or require any specific hardware components beyond the standard computer setup.

IVD (In Vitro Diagnostic)

Based on the provided information, LiverMultiScan (LMSv3) is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body (like blood, urine, tissue). LiverMultiScan analyzes medical image data acquired from an MRI scanner, which is a non-invasive imaging technique.
The intended use is for noninvasive liver evaluation using magnetic resonance imaging. This is clearly stated in the "Intended Use / Indications for Use" section.
The device description focuses on software processing of image data. It describes reading DICOM data, generating parametric maps from MRI data, and quantifying metrics from these images.
There is no mention of analyzing biological samples.

Therefore, LiverMultiScan (LMSv3) falls under the category of a medical image processing software or a radiology device software, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.

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

Product codes

LNH

Device Description

LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse.

The main functionality of LiverMultiScan (LMSv3) includes:

Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information
Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction (PDFF), T2*, T1 and iron-corrected T1 (cT1) of the liver.
Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement.
Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1).
LiverMultiScan (LMSv3) 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 (LMSv3) is intended to be used as an aid to diagnosis. The results demonstrated by LMSv3 shall only be used as an additional input to existing procedures and diagnostic workflows. The responsibility for diagnosis and treatment decisions remains with the clinicians.

LiverMultiScan (LMSv3) is a post-processing, standalone software device which has no direct contact with the human body.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance (MR)

Anatomical Site

Abdomen, Liver

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended User: Trained PD operator (internal Perspectum Diagnostics operators).
Report User: An interpreting clinician or healthcare practitioner.
Care Setting: Installation of LMSv3 is controlled and installed on general purpose workstations at PD's image analysis centre. The intended device users will log on to the workstations, access the device, and use the device on general-use HD monitors.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Phantom Testing
Sample Size: Not specified (multiple phantom scans).
Data Source: Phantom scans designed to mimic human data but provide a wider range.
Annotation Protocol: Not specified, but involved accuracy, repeatability, and reproducibility measurements on T1, T2*, and PDFF.

Clinical Performance Testing (in-vivo)
Sample Size: Not specified (volunteer data).
Data Source: In-vivo volunteer data.
Annotation Protocol: Not specified, but involved assessing precision, inter- and intra-operator variability, and worst-case variability for cT1, T2*, and PDFF measurements.

Substantial Equivalence Testing
Sample Size: Not specified (phantom and in-vivo measurements).
Data Source: Phantom measurements and in-vivo measurements comparing LMSv3 against predicate device LMSv2.1.
Annotation Protocol: Not specified, but involved comparing T1, T2*, and PDFF results between LMSv3 and LMSv2.1.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Bench Performance Testing (Phantom Testing) and Clinical Performance Testing (In-vivo).
Sample Size: Not explicitly stated for either phantom or in-vivo testing, but multiple phantom scans and volunteer data were used.
AUC: Not Found
MRMC: Not Found
Standalone Performance:

Phantom Testing:
- Accuracy: MOLLI-based T1 measurement produced by LMSv3 is consistent with literature-reported underestimation of ground truth T1. LMSv3 measurements of T2* and IDEAL PDFF are accurate over the expected physiological range. LMSv3 measurements of DIXON PDFF are relatively accurate with minor deviations due to known fat bias.
  - T1: Up to 18.89% lower to the ground truth.
  - T2*: -9.31% to 7.53% of the ground truth.
  - DIXON PDFF 30%: -28.93% to 6.83%.
  - IDEAL PDFF 30%: -5.05% to 10.70%.
- Repeatability: LMSv3 measurements of T1, T2* and PDFF are highly repeatable within the same scanner.
  - T1: -13.88 to 14.47 ms.
  - T2*: -0.89 to 1.43 ms.
  - DIXON PDFF 30%: -2.11 to 1.96%.
  - IDEAL PDFF 30%: -3.80 to 1.93 %.
- Reproducibility: LMSv3 measurements of T1, T2* and PDFF are reproducible between different scanners.
  - T1: -2.66 to 10.78%.
  - T2*: -3.43 to 2.42 ms.
  - DIXON PDFF 30%: -8.64 to 23.52%.
  - IDEAL PDFF 30%: -13.46 to 6.98%.
Clinical Performance Testing (in-vivo):
- Repeatability: LMSv3 measurements of cT1, T2* and PDFF are highly repeatable.
  - cT1 (ROI): -94.38 to 63.38 ms.
  - cT1 (Segmentation): -76.93 to 59.39 ms.
  - T2* (ROI): -6.07 to 5.70 ms.
  - DIXON PDFF (ROI): -1.77 to 3.64 %.
  - DIXON PDFF (Segmentation): -1.20 to 1.06%.
  - IDEAL PDFF (ROI): -1.92 to 1.54%.
  - IDEAL PDFF (Segmentation): -1.83 to 1.28 %.
- Reproducibility: LMSv3 measurements of cT1, T2* and PDFF are reproducible between the scanners.
  - cT1 (ROI): -89.70 to 120.58 ms.
  - cT1 (Segmentation): -84.91 to 121.79 ms.
  - T2* (ROI): -3.68 to 6.35 ms.
  - DIXON PDFF (ROI): -6.21 to 2.63%.
  - DIXON PDFF (Segmentation): -3.14 to 0.88%.
  - IDEAL PDFF (ROI): -2.66 to 2.77%.
  - IDEAL PDFF (Segmentation): -1.74 to 1.21%.
- Intra-Operator Variability: The variation introduced by operator measuring with the segmentation method is well within the prescribed acceptance criteria.
  - cT1 (ROI): -27.38 to 28.33ms.
  - cT1 (Segmentation): -20.81 to 13.06ms.
  - T2* (ROI): -2.29 to 2.91 ms.
  - DIXON PDFF (ROI): -0.78 to 1.90 %.
  - DIXON PDFF (Segmentation): -0.29 to 0.45%.
  - IDEAL PDFF (ROI): -1.26 to 1.05%.
  - IDEAL PDFF (Segmentation): -0.16 to 0.14%.
- Inter-Operator Variability: Minor additional variation introduced by having two operators examining the same metrics using ROI method.
  - cT1 (ROI): -48.05 to 39.89ms.
  - cT1 (Segmentation): -37.84 to 26.51ms.
  - T2* (ROI): -2.64 to 4.90 ms.
  - DIXON PDFF (ROI): -2.27 to 4.57%.
  - DIXON PDFF (Segmentation): -0.55 to 1.22%.
  - IDEAL PDFF (ROI): -2.09 to 1.82 %.
  - IDEAL PDFF (Segmentation): -0.37 to 0.26%.
- Worst-Case Variability: LMSv3 measurements of cT1, T2* and PDFF under the 'worst case' variability conditions are highly reproducible.
  - cT1 (ROI): -126.52 to 104.19 ms.
  - cT1 (Segmentation): -65.27 to 120.27 ms.
  - T2* (ROI): -3.68 to 6.35 ms.
  - DIXON PDFF (ROI): -2.04 to 0.76 %.
  - DIXON PDFF (Segmentation): -2.72 to 1.24%.
  - IDEAL PDFF (ROI): -3.75 to 2.83%.
  - IDEAL PDFF (Segmentation): -1.92 to 1.35%.
Substantial Equivalence Testing (against LMSv2.1):
- Phantom measurements: Negligible difference between LMSv3 and LMSv2.1 results.
  - T1: Within 3ms of the predicate device (-1.96 to 2.09ms).
  - T2*: Within 0.1ms of the predicate device (-0.08 to 0.08ms).
  - DIXON PDFF (= 30%): Within 2% of the predicate device (-1.62 to 1.02 %).
- In-vivo measurements:
  - cT1: Within 30ms of the predicate device (-28.08 to 28.73ms).
  - T2*: Within 2ms of the predicate device (-0.43 to 1.69ms).
  - DIXON PDFF: Negligible difference (-0.18 to 0.10 %).
    Key Results: All testing results were well within the acceptance criteria, concluding that LMSv3 performs as well as its predicate when used as intended. The subject device does not raise any new potential safety risks compared to the predicate and performs in accordance with its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy (95% CI Limits of Agreement), Repeatability (95% CI Limits of Agreement), Reproducibility (95% CI Limits of Agreement), Intra-Operator (95% CI Limits of Agreement (Range)), Inter-Operator (95% CI Limits of Agreement (Range)), Worst-Case Variability (95% CI Limits of Agreement (Range)).

Predicate Device(s)

K172685

Reference Device(s)

K141977, K103411

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission.

Perspectum Diagnostics Ltd Jaco Jacobs Chief Quality and Regulatory Compliance Officer 23-38 Hythe Bridge Street Oxford, Oxfordshire OX1 2ET UNITED KINGDOM

Re: K190017

Trade/Device Name: LiverMultiScan (LMSv3) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 31, 2019 Received: June 3, 2019

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.

June 27, 2019

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

1

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,

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

2

Indications for Use

510(k) Number (if known) K190017

Device Name LiverMultiScan (LMSv3)

Indications for Use (Describe)

LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.

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

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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Image /page/3/Picture/2 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font on the top line. Below that, the word "Diagnostics" is written in a lighter gray font. To the right of the words is a colorful circular logo with yellow, green, blue, and pink sections.

Date Prepared: 26th June 2019

1. Submitter Details

| Owner Address: | Perspectum Diagnostics Ltd
23-38 Hythe Bridge Street
Oxford,
Oxfordshire,
OX1 2ET
United Kingdom |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Owner/Operator Number: | 10056574 |
| Establishment Registration Number: | 3014232555 |
| Contact Person: | Dr Jaco Jacobs
jaco.jacobs@perspectum-diagnostics.com
+44 (0) 1865 655329 |

2. Subject and Predicate Device

	Subject Device	Predicate Device
510(k) number	K190017	K172685
Legal Manufacturer	Perspectum Diagnostics Ltd	Perspectum Diagnostics Ltd
Owner/Owner Operator	Perspectum Diagnostics Ltd	Perspectum Diagnostics Ltd
Device Name	LMSv3	LMSv2
Proprietary/Common	LiverMultiScan	LiverMultiScan
Panel	Radiology	Radiology
Regulation	21 CFR 892.1000	21 CFR 892.1000
Risk Class	Class II	Class II
Product Class code	LNH	LNH
Classification	Magnetic Resonance Diagnostic Device	Magnetic Resonance Diagnostic Device

3. Subject Device Description

LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse.

The main functionality of LiverMultiScan (LMSv3) includes:

. Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information
Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction PDFF), T2*, T1 and ironcorrected T1 (cT1) of the liver.
Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement.

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Image /page/4/Picture/1 description: The image is a logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black font, and the word "Diagnostics" is in a smaller, gray font. To the right of the words is a colorful circle with four different colors: yellow, blue, green, and pink.

Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver ● (PDFF), T2* and iron-corrected T1 (cT1).
LiverMultiScan (LMSv3) 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 (LMSv3) is intended to be used as an aid to diagnosis. The results demonstrated by LMSv3 shall only be used as an additional input to existing procedures and diagnostic workflows. The responsibility for diagnosis and treatment decisions remains with the clinicians.

LiverMultiScan (LMSv3) is a post-processing, standalone software device which has no direct contact with the human body.

LiverMultiScan (LMSv3) presents a moderate level of concern.

Intended Use

Subject Device, LMSv3

"LiverMultiScan (LMSv3) 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.

LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.

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

4. Subject and Predicate Comparison

4.1. Intended Use Comparison

The subject device and the predicate device are both indicated for use in the non-invasive evaluation of the liver, which enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. Both devices are designed to utilize DIXCOM 3.0 data as input and provide a range of tools to display and process data to determine triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.

4.2. Subject and Predicate Device Comparison

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

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Image /page/5/Picture/1 description: The image is a logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black font, and the word "Diagnostics" is in a smaller, gray font. To the right of the words is a circular logo with four different colored sections: yellow, green, blue, and pink. The logo is a ring with a gap in the middle, and the pink section is a half-circle.

Comparison of subject and Predicate Device
Characteristic	LMSv3 (Subject device)	LMSv2 (Predicate device)
Intended Use
and Indications
for Use	"LiverMultiScan (LMSv3) is indicated for use as a
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.

LiverMultiScan (LMSv3) is designed to utilize
DICOM 3.0 compliant magnetic resonance image
datasets, acquired from compatible MR Systems,
to display the internal structure of the abdomen
including the liver. Other physical parameters
derived from the images may also be produced.

LiverMultiScan (LMSv3) provides a number of
tools, such as automated liver segmentation and
region of interest (ROI) placements, to be used
for the assessment of selected regions of an
image. Quantitative assessment of selected
regions includes the determination of
triglyceride fat fraction in the liver (PDFF), T2*
and iron-corrected T1 (cT1) measurements. PDFF
may optionally be computed using the LMS
IDEAL or three-point Dixon methodology.

These images and the physical parameters
derived from the images, when interpreted by a
trained clinician, yield information that may
assist in diagnosis." | "LiverMultiScan is indicated for use
as a 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.

LiverMultiScan 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 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." |
| Target
Population | Patients suitable to undergo an MRI scan and not
contra-indicated for MRI. | Patients suitable to undergo an MRI scan and not
contra-indicated for MRI. |
| Device User | Trained PD operator | Trained PD operator |
| Report User | An interpreting clinician or healthcare
practitioner | An interpreting clinician or healthcare
practitioner |
| Device Use
Environment | Installation of LMSv3 is controlled and installed
on general purpose workstations at PD's image
analysis centre | Installation of LMSv2 is controlled and installed
on general purpose workstations at PD's image
analysis centre |
| Clinical Setting | LMSv3 is a standalone software device that's
intended to be installed on general use
workstations at PD's image analysis centre. The
intended device users will log on to the | LMSv2 is a standalone software device that's
intended to be installed on general use
workstations at PD's image analysis centre. The
intended device users will log on to the |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| | workstations, access the device, and use the
device on general-use HD monitors. | workstations, access the device, and use the
device on general-use HD monitors. |
| | LMSv3 is a post-processing software, the
intended device users are trained internal PD
operators. | LMSv2 is a post-processing software, the
intended device users are trained internal PD
operators. |
| | The end-users for the output from the device,
the pdf report, are clinicians who receive and
interpret LMSv3 reports. | The end-users for the output, the pdf report, are
clinicians who receive and interpret LMSv2
reports. |
| Anatomical
Location | Abdomen, Liver | Abdomen, Liver |
| Energy
Considerations | Software only application. The device, a
standalone software application, does not
deliver, monitor or depend on energy delivered
to or from patients. | Software only application. The device, a
standalone software application, does not
deliver, monitor or depend on energy delivered
to or from patients. |
| Design:
Purpose | Standalone software application to facilitate the
import and visualization of MR data sets
encompassing the abdomen, including the liver
with functionality independent of the MRI
equipment vendor.

Software application intended to display and
visualize 2D multi-slice, spin-echo MR data sets
encompassing the abdomen. The user may
process, and review DICOM 3.0 compliant
datasets within the system. | Standalone software application to facilitate the
import and visualization of MR data sets
encompassing the abdomen, including the liver
with functionality independent of the MRI
equipment vendor.

Software application intended to display and
visualize 2D multi-slice, spin-echo MR data sets
encompassing the abdomen. The user may
process, and review DICOM 3.0 compliant
datasets within the system and/or across
computer networks. |
| Design: Tools | Allows for the visualisation via parametric maps
and quantification of metrics (cT1, T2* and PDFF)
from liver tissue and exportation of results &
images to a deliverable pdf report*.

LMSv3 allows for:
cT1 ROI placed method on the cT1 map with IQR
and median metrics from the placed ROI's
potentially across multiple acquired slices. Full segmentation of the outer liver contour
and liver vasculature of the cT1 parametric
map. IQR and median metrics are reported
from the segmentation. T2* ROI placed method on the T2* map with
IQR and median metrics from the placed
ROI's potentially across multiple acquired | Allows for the visualisation via parametric maps
and quantification of metrics (cT1, T2* and PDFF)
from liver tissue and exportation of results &
images to a deliverable pdf report.

LMSv2 allows for:
cT1 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 |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| | slices T2* parametric maps are calculated
from the Gradient Multi-Echo method.

PDFF ROI placed method on the PDFF map with
IQR and median metrics from the placed
ROI's potentially across multiple acquired
slices potentially across multiple acquired
slices. PDFF parametric maps can be calculated
using either the LMS IDEAL method [2] or
the three-point DIXON method. [1] Full liver segmentation of the PDFF
parametric map where IQR and median
metrics are reported from the
segmentation. | ROI's potentially across multiple acquired
slices T2* parametric maps are calculated
from the Gradient Multi-Echo method.

PDFF ROI placed method on the PDFF map with
IQR and median metrics from the placed
ROI's potentially across multiple acquired
slices potentially across multiple acquired
slices. PDFF parametric maps are calculated from
the three-point DIXON method. [1] |
| Design:
Algorithms | Previously cleared algorithms:
Noise Determination Algorithms T1 mapping Algorithms T2* mapping Algorithms Unwrapping Phase Image Algorithms Creation of cT1 image Algorithms Water and Fat Mapping Algorithms New algorithms: IDEAL Processing Algorithms MAGO Processing Algorithms Quality Check for Shimming Automatic Liver Segmentation Algorithms Segmentation Mapping to T2*/PDFF
algorithms LMSv3 uses identical algorithms cleared in LMSv2
to quantify cT1, T2* and DIXON PDFF using ROI's. | Noise Determination Algorithms T1 mapping Algorithms T2* mapping Algorithms Unwrapping Phase Image Algorithms Creation of cT1 image Algorithms Water and Fat Mapping Algorithms |
| Design: MR
Relaxometry | T1, iron-corrected T1 (cT1) and T2* mapping. | T1, iron-corrected T1 (cT1) and T2* mapping. |
| Design: Liver
Fat
Quantification | Utilizes MR images that exploit the difference in
resonance frequencies between hydrogen nuclei
in water and triglyceride fat using either LMS
IDEAL method or three-point DIXON method. | Utilizes MR images that exploit the difference in
resonance frequencies between hydrogen nuclei
in water and triglyceride fat using the three-
point DIXON method. |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| Design: Liver
Segmentation | 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. | Does not support whole liver segmentation. See
first reference device below, LiverLab. |
| Design: Regions
of Interest
(ROI) | Median and interquartile range measurements
created from a cross sectional slice of liver
tissue. For each parametric map, statistics from
multiple Regions of Interest (ROIs) — potentially
placed across multiple slices – are summarised.

Also supports the display of 'Live' ROI statistics
when moving the ROI across the parametric
map. | Median and interquartile range measurements
created from a cross sectional slice of liver
tissue. For each parametric map, statistics from
multiple Regions of Interest (ROIs) — potentially
placed across multiple slices - are summarised.

Also supports the display of 'Live' ROI statistics
when moving the ROI across the parametric
map. |
| Design:
Parametric
Maps | Iron corrected T1 (cT1), T2* and triglyceride fat
(i.e. DIXON or IDEAL Proton Density Fat Fraction
(PDFF)) parametric maps are supported.

PDFF parametric maps are calculated with either
MAGNITUDE ONLY-IDEAL, when the data is
received from GE and Phillips scanners, and
COMPLEX-IDEAL for Siemens. When analysing
COPLEX-IDEAL data a field map is also available
during analysis. PDFF may also be calculated
using the three-point DIXON method. | Iron corrected T1 (cT1), T2* and triglyceride fat
(i.e. DIXON Proton Density Fat Fraction (PDFF))
parametric maps are supported. |
| Design:
Visualisation | Iron corrected T1 (cT1), T2* and triglyceride fat
(also known as Proton Density Fat Fraction
(PDFF)) parametric maps are supported.

Iron corrected T1 (cT1) displayed using LMSv3
colourmap, designed to have maximum contrast
on liver parenchymal tissue. | Iron corrected T1 (cT1), T2* and triglyceride fat
(also known as Proton Density Fat Fraction
(PDFF)) parametric maps are supported.

Iron corrected T1 (cT1) displayed using LMSv2
colourmap, designed to have maximum contrast
on liver parenchymal tissue. |
| Design:
Supported
Modalities | DICOM 3.0 compliant MR data from supported
MRI scanners. | DICOM 3.0 compliant MR data from supported
MRI scanners. |
| Design: Report | Quantified metrics from liver tissue and image
analysis collated in a deliverable pdf report.

Histogram of segmented area and proportion of
PDFF intensities are included in the final report
to give a better understanding on the
distribution of PDFF intensities. | Quantified metrics from liver tissue and images
analysis collated in a deliverable pdf report. |
| Comparison of subject and Predicate Device | | |
| Characteristic | LMSv3 (Subject device) | LMSv2 (Predicate device) |
| Compatibility
with the
environment | Installation of LMSv3 is controlled and is installed
on general purpose workstations at PD's image
analysis centre.
LMSv3 reads in local files compliant with DICOM
3.0. | Installation of LMSv2 is controlled and is installed
on general purpose workstations at PD's image
analysis centre.
LMSv2 reads in local files compliant with DICOM
3.0. |
| Performance | Validated with phantom scans, synthetic raw
data and volunteer scans covering a range of
physiological values for cT1, T2* and PDFF. | Validated with phantom scans, synthetic raw
data and volunteer scans covering a range of
physiological values for cT1, T2* and PDFF. |
| Supported MRI
Systems | Validated across all listed supported
manufacturers and field strengths. | Validated across all listed supported
manufacturers and field strengths. |
| Standards | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO
13485 | IEC 62304, DICOM 3.0, ISO 14971, ISO 13485 |
| System/Operati
ng 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. |
| Mechanical
Safety | 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. |

6

Image /page/6/Picture/0 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, black font, while the word "Diagnostics" is written in a smaller, gray font. To the right of the words is a colorful, circular logo with yellow, blue, green, and pink sections.

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Image /page/7/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font. Below it and slightly to the right, the word "Diagnostics" is written in a lighter gray font. To the right of the words is a circular logo with four different colored sections: yellow, green, blue, and pink.

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Image /page/8/Picture/0 description: The image is the logo for Perspectum Diagnostics. The logo has the word "Perspectum" in bold black font, with the word "Diagnostics" in gray font to the right and slightly below the first word. To the right of the words is a circular logo with four different colored sections: yellow, green, blue, and pink.

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Image /page/9/Picture/0 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font, while the word "Diagnostics" is written in a lighter gray font and is slightly smaller in size. To the right of the text is a circular logo with four different colored sections: yellow, blue, green, and pink.

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

4.3. Sterilization and Shelf Life

LMSv3 is a post-processing standalone software device thus is non-invasive and non-sterile. The shelf life of LMSv3 is indefinite as long as the manufacturer continues to support the device. Both sterilization and shelf life characteristics are equivalent to the predicate device.

4.4. Biocompatibility

LMSv3 is a post-processing standalone software device thus it is non-contact and non-invasive. Biocompatibility testing was not deemed necessary to demonstrate the safety and effectiveness of LMSv3 does not consists of materials that differ from the predicate device.

4.5. Software

LMSv3 was successfully validated and verified against the requirements specification and it's intended use. The results from the validation and verification activities, documented in this submission, corroborate that LMSv3 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. LMSv3 is also in compliance with the DICOM standard.

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Image /page/10/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font. Below it, the word "Diagnostics" is written in a smaller, light gray font. To the right of the words is a circular graphic with four colored sections: yellow, light blue, light green, and pink.

The verification and validation activities conducted demonstrates that LMSv3 is at least as safe and effective as the predicate device and does not introduce any new risks.

4.6. Electromagnetic and Electrical Safety

LMSv3 is a standalone software device. There are no electrical safety risks associated with the direct use of the LMsv3 device. Electromagnetic or electrical safety testing was not deemed necessary to demonstrate the safety and effectiveness of LMSv3.

4.7. Discussion

According to the comparisons between the subject device, we can conclude that the subject device does not raise any new potential safety risks when compared to the chosen predicate device and performs in accordance with its intended use.

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 equivalent .
. The subject device and predicate device both support multi-slice MR data acquired using the specific acquisition protocols, from supported MR Systems, to acquire the input data
. The subject and predicate devices include software applications which utilise MR data to visualise and enable quantification of physiological characteristics in the liver to provide measurements which may be used to aid diagnosis
. Both the subject device and the predicate device include applications to facilitate the import and visualization of MR data sets and include tools to enable the manipulation of the views and to enable the quantification and analysis of tissue characteristics in the liver from the MR data
The subject and predicate device are both standalone software applications to facilitate the import and . visualization of MR data sets
The subject and predicate devices enable the quantification of analysis of tissue characteristics in the liver from . the MR data
The subject and predicate devices both support the region of interest (ROI) measurements derived from MR . images and parametric maps of tissue characteristics
The subject and predicate device use the same algorithms for the ROI measurements on cT1, T2* and DIXON . PDFF
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
The reports produced from both the subject and predicate device include tabular display of quantification . statistics, parametric map images and include normal range references
. Both the subject and predicate devices are designed to run on general-purpose computing hardware
Both the subject and predicate device are intended to be used in the same use environment and by trained PD . operators
Performance testing demonstrates that the subject device performs at least as safely and effectively as the . proposed predicate device

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5. Reference Devices

5.1. First Reference Device

Legal manufacturer:	Siemens AG
Common name:	Software syngo MR E11A for the MAGNETOM systems Aera/Skyra
Device name/Trade name:	MAGNETOM Aera
MAGNETOM Skyra
Classification Regulation:	21 CFR 892.1000
510(k) Number:	K141977
Regulation Name:	Magnetic Resonance Diagnostic Device
Device Classification:	Class II
Device Panel:	Radiology
Device Product Code:	LNH

5.2.	Second Reference Device
Legal manufacturer:	GE Medical Systems
Common name:	IDEAL IQ Software Option
Device name/Trade name:	IDEAL IQ Software Option
Classification Regulation:	21 CFR 892.1000
510(k) Number:	K103411
Regulation Name:	Magnetic Resonance Diagnostic Device
Device Classification:	Class II
Device Panel:	Radiology
Device Product Code:	LNH

We make use of other legally marketed devices as reference devices to abridge differences in technological characteristics between the predicate and subject device and to substantiate claims that no different questions of safety and effectiveness are raised using a reference device that is already 510(k) cleared and legal marketed.

6. Performance Testing

General

LMSv3 underwent full performance testing under controlled conditions to corroborate that it is safe and effective to use. The performance testing conducted demonstrates that LMSv3 is at least as safe and effective as the predicate device and does not introduce any new risks.

6.1. Performance Testing – Bench

Phantom Testing

The phantom performance testing was conducted to verify the accuracy, repeatability of the device measurements on the phantoms which were designed to mimic the human data but provide a wider range.

The results of worst-case scenarios are summarized in the tables below, demonstrating:

The MOLLI-based T1 measurement produced by LMSv3 is consistent with the literature-reported . underestimation of ground truth T1 using MOLLI techniques [3][4].
LMSv3 measurements of T2* and IDEAL PDFF are accurate over the expected physiological range of values. .
LMSv3 measurements of DIXON PDFF are relatively accurate over the expected physiological range of values. • There are only minor deviations due to the known fat bias associated with the DIXON method.

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Phantom Metrics	Accuracy
	95% CI Limits of Agreement
T1	Up to 18.89% lower to the ground truth
T2*	- 9.31% to 7.53% of the ground truth
DIXON PDFF 30%	-28.93% to 6.83%
IDEAL PDFF 30%	-5.05% to 10.70%

LMSv3 measurements of T1, T2* and PDFF are highly repeatable within the same scanner •

LMSv3 measurements of T1, T2* and PDFF are reproducible between different scanners .

| Phantom Metrics | Repeatability
95% CI Limits of Agreement | Reproducibility
95% CI Limits of Agreement |
|------------------|---------------------------------------------|-----------------------------------------------|
| T1 | - 13.88 to 14.47 ms | - 2.66 to 10.78% |
| T2* | - 0.89 to 1.43 ms | - 3.43 to 2.42 ms |
| DIXON PDFF 30% | - 2.11 to 1.96% | - 8.64 to 23.52% |
| IDEAL PDFF 30% | - 3.80 to 1.93 % | - 13.46 to 6.98% |

Performance Testing – Clinical 6.2.

ln-vivo

The performance testing using in-vivo volunteer data was conducted to assess the precision of LMSv3, inter- and intra- operator variability and the worst-case variability.

The results of worst-case scenarios are summarized in the tables below and demonstrate the following:

LMSv3 measurements of cT1, T2* and PDFF are highly repeatable ●
LMSv3 measurements of cT1, T2* and PDFF are reproducible between the scanners ●
. The variation introduced by operator measuring with the segmentation method is well within the prescribed acceptance criteria. There is only minor additional variation introduced by having two operators examining the same metrics using ROI method.
LMSv3 measurements of cT1, T2* and PDFF under the 'worst case' variability conditions are highly reproducible

| Volunteer Metrics | Repeatability
95% CI Limits of Agreement | Reproducibility
95% CI Limits of Agreement |
|---------------------------|---------------------------------------------|-----------------------------------------------|
| cT1 (ROI) | - 94.38 to 63.38 ms | -89.70 to 120.58 ms |
| cT1 (Segmentation) | -76.93 to 59.39 ms | -84.91 to 121.79 ms |
| T2* (ROI) | - 6.07 to 5.70 ms | -3.68 to 6.35 ms |
| DIXON PDFF (ROI) | -1.77 to 3.64 % | -6.21 to 2.63% |
| DIXON PDFF (Segmentation) | -1.20 to 1.06% | -3.14 to 0.88% |
| IDEAL PDFF (ROI) | -1.92 to 1.54% | -2.66 to 2.77% |
| IDEAL PDFF (Segmentation) | -1.83 to 1.28 % | -1.74 to 1.21% |

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| Volunteer Metrics | Intra-Operator
95% CI Limits of Agreement
(Range) | Inter-Operator
95% CI Limits of Agreement
(Range) |
|---------------------------|---------------------------------------------------------|---------------------------------------------------------|
| cT1 (ROI) | -27.38 to 28.33ms | -48.05 to 39.89ms |
| cT1 (Segmentation) | -20.81 to 13.06ms | -37.84 to 26.51ms |
| T2* (ROI) | -2.29 to 2.91 ms | -2.64 to 4.90 ms |
| DIXON PDFF (ROI) | -0.78 to 1.90 % | -2.27 to 4.57% |
| DIXON PDFF (Segmentation) | -0.29 to 0.45% | -0.55 to 1.22% |
| IDEAL PDFF (ROI) | -1.26 to 1.05% | -2.09 to 1.82 % |
| IDEAL PDFF (Segmentation) | -0.16 to 0.14% | -0.37 to 0.26% |

| Volunteer Metrics | Worst-Case Variability
95% CI Limits of Agreement (Range) |
|---------------------------|--------------------------------------------------------------|
| cT1 (ROI) | -126.52 to 104.19 ms |
| cT1 (Segmentation) | - 65.27 to 120.27 ms |
| T2* (ROI) | -3.68 to 6.35 ms |
| DIXON PDFF (ROI) | -2.04 to 0.76 % |
| DIXON PDFF (Segmentation) | -2.72 to 1.24% |
| IDEAL PDFF (ROI) | -3.75 to 2.83% |
| IDEAL PDFF (Segmentation) | -1.92 to 1.35% |

6.3. Performance Testing - Substantial Equivalence

The substantial equivalence testing conducted on LMSv3 against its predicate device, LMSv2, is summarized in the tables below. The latest version of predicate, LMSv2.1 was used in this testing.

Phantom measurements show the negligible difference between the results of LMSv3 and LMSv2.1. LMSv3 produces T1 value within in 3ms and T2* value within in 0.1ms of the predicate device. PDFF is within 1% of the predicate device when measuring PDFF30%.

Phantom Metric	Results (Range)
	95% CI Limits of Agreement
T1	-1.96 to 2.09ms
T2*	-0.08 to 0.08ms
DIXON PDFF (