Who is the manufacturer of LiverMultiScan?

Perspectum Diagnostics, Ltd. filed the 510(k) submission for LiverMultiScan (K172685).

What is the FDA product code for LiverMultiScan?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LiverMultiScan?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LiverMultiScan?

LiverMultiScan (LMSv1) (K143020).

Who can help prepare an FDA 510(k) submission like LiverMultiScan?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LiverMultiScan

K172685 · Perspectum Diagnostics, Ltd. · LNH · Nov 21, 2017 · Radiology

Device Facts

Record ID	K172685
Device Name	LiverMultiScan
Applicant	Perspectum Diagnostics, Ltd.
Product Code	LNH · Radiology
Decision Date	Nov 21, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

LiverMultiScan (LMSv2) 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 (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

Device Story

LiverMultiScan (LMSv2) is a standalone software application for general-purpose workstations; processes DICOM 3.0 compliant MR image datasets (GRE Echo and MOLLI protocols) of the abdomen. Transforms raw MR data into parametric maps (T1, iron-corrected T1/cT1, T2*, and triglyceride fat fraction/PDFF) using relaxometry algorithms. Provides quantification tools including circular Region of Interest (ROI) placements for tissue assessment. Used by trained operators; results interpreted by radiologists, gastroenterologists, or hepatologists to support clinical workflows. Output includes parametric maps, quantification statistics, and reports. Benefits include noninvasive quantification of liver tissue characteristics to aid in diagnosis.

Clinical Evidence

Bench testing included phantom scans and in-vivo volunteer data. Phantom testing confirmed accuracy for T1, T2*, and PDFF across physiological ranges. In-vivo testing demonstrated high repeatability and reproducibility across systems. Intra-operator and inter-operator variability were within acceptance criteria. Head-to-head comparison with predicate showed negligible differences in T1, T2*, and PDFF measurements (e.g., cT1 within 40ms, T2* within 1ms). No clinical diagnostic trials required.

Technological Characteristics

Standalone software application; runs on general-purpose workstations (Mac OS). Inputs: DICOM 3.0 compliant MR data (GRE Echo, MOLLI). Outputs: Parametric maps (T1, cT1, T2*, PDFF), ROI statistics, reports. Algorithms: Relaxometry-based quantification using three-point DIXON method for fat fraction. Standards: IEC 62304, DICOM 3.0, ISO 14971, ISO 13485.

Indications for Use

Indicated for noninvasive liver evaluation in patients suitable for MRI. Used by trained operators to generate, display, and review 2D MR image data and pixel maps for MR relaxation times to assist clinicians in diagnosis.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

LiverMultiScan (LMSv1) (K143020)

Related Devices

K202170 — LiverMultiScan · Perspectum, Ltd. · Oct 2, 2020
K253413 — LiverMultiScan (v6.0) · Perspectum, Ltd. · Mar 9, 2026
K143020 — LiverMultiScan · Mirada Medical, Ltd. · Jun 23, 2015
K190017 — LiverMultiScan (LMSv3) · Perspectum Diagnostics, Ltd. · Jun 27, 2019
K213960 — LiverMultiScan v5 (LMSv5) · Perspectum · Sep 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ November 21, 2017 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Perspectum Diagnostics Ltd. % Jaco Jacobs Chief Compliance Officer 23-38 Hythe Bridge Street Oxford. Oxfordshire OX1 2ET UNITED KINGDOM Re: K172685 Trade/Device Name: LiverMultiScan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 1, 2017 Received: September 6, 2017 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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Sincerely, Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172685 Device Name LiverMultiScan (LMSv2) #### Indications for Use (Describe) LiverMultiScan (LMSv2) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSy2) 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. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------------------------| | <div> ✖ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92. ## 1. Submitter | Name: | Perspectum Diagnostics Ltd | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Address: | Perspectum Diagnostics Ltd 23-38 Hythe Bridge Street Oxford OX1 2ET United Kingdom | | Contact Person: | Dr. Jaco Jacobs | | Date Prepared: | 1st September 2017 | | 2. Subject Device Name of Device: | LiverMultiScan (LMSv2) | | Classification Name: | Magnetic Resonance Diagnostic Device | | Regulation: | 21 CFR 892.1000 | | Regulatory Class: | Class II | | Product Classification Code: | LNH | | 3. Predicate Device Name of predicate device: | LiverMultiScan (LMSv1) | | Predicate Manufacturer: | Mirada Medical Ltd Oxford Centre for Innovation New Road Oxford OX1 1BY United Kingdom | | Predicate Trade Name: | LiverMultiScan | # 4. Reference Device No reference devices were used in this submission. # 5. Device Description LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font, with the word "Diagnostics" written in a lighter gray font underneath. To the right of the text is a circular graphic with four colored sections: blue, yellow, green, and pink. The pink section is split in half by a white line. LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets. LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements. LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow. LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat. LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists. LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows. LiverMultiScan (LMSv2) offers the following. - ു Advanced visualisation of MR data. - C Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage). - Circular region of interest statistics. - Snapshot of images to include in a report. - Report to include region statistics, snapshot images and user-entered text. - Export of snapshot images to report. ## 6. Indications for Use "LiverMultiScan (LMSv2) 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 (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis." {5}------------------------------------------------ Image /page/5/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 lighter gray font. To the right of the text is a circular logo with four colored sections: yellow, blue, green, and pink. #### 7. Comparison to Predicate The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence. #### Overview The subject device is substantially equivalent to the predicate device, both regulated under regulation 21 CFR 892.1000, Magnetic Resonance Diagnostic Device. - C 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. - C The subject and predicate devices are both standalone software applications to facilitate the import and visualization of MR data sets. - 3 Both the subject and predicate devices are designed to run on general-purpose computers. - G 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. - a 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 use the same algorithmic specifications to support quantitative analysis. - G The subject and predicate devices both support region of interest measurements derived from MR images and parametric maps of tissue characteristics. - The subject and predicate devices facilitate the creation of a medical report containing the images and analysis output derived from quantification of liver tissue parameters. - G The subject and predicate device reports all include tabular display of quantification statistics, parametric map images and include normal range references. - © Performance testing demonstrates that the subject device performs at least as safely and effectively as the proposed predicate. | Characteristic | LMSv2 (Subject) | LMSv1 (Predicate) | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | Not known | K143020 | | Regulation | 21 CFR 892.1000 | 21 CFR 892.1000 | | Regulatory Class | Class II | Class II | | Product Code | LNH | LNH | | Manufacturer | Perspectum Diagnostics Ltd | Mirada Medical Ltd | | Intended Use and Indications for Use | LiverMultiScan is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. | LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. | | | 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. | LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows. | | | These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | These images and the physical parameters derived from the images, when interpreted by a trained physician, 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 operator | Trained clinician | | Report User | Interpreting clinician | Interpreting clinician | | Anatomical Location | Abdomen, Liver | Abdomen, Liver | | Energy Considerations | Software only application. The device, a standalone software application, does not deliver or depend on energy delivered to or from patients. | Software only application. The device, a standalone software application, does not deliver 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 and/or across computer networks. | 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: 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 the 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. | | | | | | Design: Parametric Maps | Iron corrected T1 (cT1), T2* and triglyceride fat (also known as Proton Density Fat Fraction (PDFF)) parametric maps are supported. | Iron corrected T1 (cT1), T2* and triglyceride fat (also known as Proton Density Fat Fraction (PDFF)) parametric maps are supported. | | Design: Visualisation | Iron corrected T1 (cT1) displayed using LMS colourmap, designed to have maximum contrast on liver parenchymal tissue. | Iron corrected T1 (cT1) displayed using LMS grayscale colourmap. | | Design: Region 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. | Mean, median, standard deviation, interquartile range measurements created from a cross sectional slice of liver tissue. | | Design: Supported Modalities | DICOM 3.0 compliant MR data from GRE Echo and MOLLI acquisition protocols. | DICOM 3.0 compliant MR data from GRE Echo and MOLLI acquisition protocols. | | Design: Reporting | Liver quantification images and analysis collated in a report. | Liver quantification images and analysis collated in a report. | | Performance | Validated with phantom scans, synthetic raw data and volunteer scans covering a range of physiological values for cT1, T2* and PDFF. | Validated with volunteer and phantom scans. | | Supported Systems | Validated across all supported manufacturers and field strengths. | Validated on Siemens Skyra (3T). | | Standards | IEC 62304, DICOM 3.0, ISO 14971, ISO 13485 | IEC 62304, DICOM | | Operating System | Mac OS | Microsoft Windows | | 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. | #### Device Comparison Table {6}------------------------------------------------ Image /page/6/Picture/4 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 lighter gray font. To the right of the words is a colorful circular logo with yellow, blue, green, and pink colors. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is in bold, dark gray font, and the word "Diagnostics" is in a lighter gray font and is located underneath the word "Perspectum". To the right of the words is a colorful circular logo that is divided into four sections: yellow, green, blue, and pink. In conclusion, the subject device does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicate. ## 8. Performance Data #### Introduction Substantial equivalence performance testing will consist of a head-to-head evaluation of the subject and predicate devices' ability to measure (corrected) T1, T2* and PDFF using phantoms as well as in-vivo volunteer data. For in-vivo performance data please see For each of the comparisons, the following will be calculated: - ട Mean difference in T1/ T2* and PDFF (magnitude of the bias) - Standard deviation - ල Bland-Altman 95% limits of agreement {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in bold, dark gray letters. Below it, the word "Diagnostics" is written in a lighter shade of gray. To the right of the text is a circular graphic with four colored sections: yellow, green, blue, and pink. ි Slope of bias #### Phantom The performance of LMSv2, as summarised in the tables below demonstrates that: - o The MOLLI-based T1 measurement produced by LMSv2 is consistent with the literature-reported underestimation of ground truth T1 using MOLLI techniques 1,2. - LiverMultiScan (LMSv2) measurement of T2* is accurate over the expected physiological range of values. - o LiverMultiScan (LMSv2) measurement of PDFF is accurate over the expected physiological range of values. | Phantom metric | Accuracy 95% CI Limits of Agreement Performance metric | |-------------------|--------------------------------------------------------------| | T1 | 19-25% lower than ground truth | | T2* | +/- 2ms | | PDFF < 30% | +/- 3% | | PDFF ≥ 30% | +/- 21% | - LiverMultiScan (LMSv2) measurement of T1 is highly repeatable. - LiverMultiScan (LMSv2) measurement of T1 is both repeatable within the same system and reproducible between systems. - LiverMultiScan (LMSv2) measurement of T2* is highly repeatable. - o LiverMultiScan (LMSv2) measurement of T2* is both repeatable within the same system reproducible between systems at the same field strength. - LiverMultiScan (LMSv2) measurement of PDFF is highly repeatable. - o LiverMultiScan (LMSv2) measurement of PDFF is reproducible between systems. | Phantom | Repeatability 95% Cl Limits of Agreement | Reproducibility 95% Cl Limits of Agreement | |------------|---------------------------------------------|-----------------------------------------------| | metric | Performance metric | Performance metric | | T1 | +/- 10ms | -34 to 27ms | | T2* | +/- 1.7ms | +/- 4ms | | PDFF < 30% | -2.5 to 1 % | +/- 4% | | PDFF ≥ 30% | +/- 5% | +/-10 % | 1 Piechnik et al. (2010) Journal of Cardiovascular Magnetic Resonance 12:69 2 Puntmann et al. (2013) Journal of Cardiovascular Magnetic Resonance 15(Suppl 1):E18 {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for Perspectum Diagnostics. The word "Perspectum" is in bold, black font, and the word "Diagnostics" is in a smaller, gray font underneath. To the right of the words is a circular logo with four different colored sections: blue, yellow, green, and pink. There is a trademark symbol in the upper right corner of the logo. #### In Vivo The in vivo performance testing of LMSv2, as summarised in the table below demonstrates that: - LiverMultiScan (LMSv2) measurement of cT1 is highly repeatable. o - o LiverMultiScan (LMSv2) measurement of cT1 is reproducible between systems. - LiverMultiScan (LMSv2) measurement of T2* is highly repeatable. - o LiverMultiScan (LMSv2) measurement of T2* is reproducible between systems at the same field strength. - LiverMultiScan (LMSv2) measurement of PDFF is highly repeatable. - LiverMultiScan (LMSv2) measurement of PDFF is reproducible between systems. | Volunteer metric | Repeatability 95% Cl Limits of Agreement Performance metric | Reproducibility 95% CI Limits of Agreement Performance metric | |---------------------|-------------------------------------------------------------------|---------------------------------------------------------------------| | cT1 | +/- 60ms | +/- 120ms | | T2* | +/- 7ms | +/- 10ms | | PDFF | +/- 1% | +/- 2% | As demonstrated in the table below, the variation introduced by operator reading (use of LMSv2) is well within the proscribed acceptance criteria. There is only minor additional variation introduced by having two readers read the same study compared to the same reader performing a second analysis blinded. | Volunteer metric | Intra-operator 95% CI Limits of Agreement Performance metric | Inter-operator 95% CI Limits of Agreement Performance metric | |---------------------|--------------------------------------------------------------------|--------------------------------------------------------------------| | cT1 | +/- 18ms | +/- 25ms | | T2* | +/- 3ms | +/- 4ms | | PDFF | +/- 1% | +/- 1.1% | #### Substantial Equivalence The substantial equivalence testing of LMSv2 versus its predicate device, LMSv1, is summarised in the tables below. Phantom measurements show that LMSv2 produces T1 and T2* values within 1ms of the predicate (negligible difference). PDFF is within 1% of the predicate where PDFF < 30%, and within 2% at higher percentages. | Metric | Phantom Equivalence 95% CI Limits of Agreement | |--------|---------------------------------------------------| |--------|---------------------------------------------------| {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, sans-serif font in black. Below it, the word "Diagnostics" is written in a smaller, lighter gray font. To the right of the text is a circular graphic with four colored sections: yellow, green, blue, and pink. The graphic is divided horizontally, with the top half showing the yellow, green, and blue sections, and the bottom half showing the pink section. | | Performance metric | |------------|--------------------| | T1 | -0.5 to 0.4ms | | T2* | -0.4 to 0.2ms | | PDFF < 30% | -0.6 to 0.4% | | PDFF ≥ 30% | -1.6 to 2% | In vivo measurements show that cT1 values produced by LMSv2 lie within 40ms of the predicate device, with T2* values within 1ms. There is negligible difference in the measurement of PDFF between LMSv2 and the predicate. | Metric | In vivo Equivalence 95% CI Limits of Agreement | | |--------|---------------------------------------------------|--| | | Performance metric | | | cT1 | -14.8 to 40ms | | | T2* | -0.5 to 0.8ms | | | PDFF | -0.4 to 0.2% | | In summary, as all acceptance criteria were met, we conclude that LMSv2 is substantially equivalent to its predicate, LMSv1. #### Summarv In conclusion, performance testing demonstrates that LiverMultiScan (LMSv2) is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. In-vivo and phantom clinical performance criteria established were successfully met during the performance evaluation. LiverMultiScan (LMSv2) meets requirements for safety and effectiveness and does not introduce any new potential safety risks. #### 9. Biocompatibility Testing Not applicable as the LiverMultiScan (LMSv2) device is standalone software. ## 10. Electrical Safety and Electromagnetic Compatibility (EMC) Not applicable as the LiverMultiScan (LMSv2) device is standalone software. ## 11. Software Verification and Validation Testing LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned software verification and validation testing included in this submission. The results of verification and validation testing demonstrate that LiverMultiScan meets the user needs and requirements of the device, which are demonstrated to be substantially equivalent to those of the listed predicate device. {11}------------------------------------------------ Image /page/11/Picture/1 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 positioned below the first word. To the right of the words is a circular logo with four different colored sections: yellow, blue, green, and pink. Verification and Validation for LiverMultiScan has been carried out in compliance with the requirements of ISO 13485:2003, 21 CFR Part 820 and in adherence to the DICOM standard. In conclusion, software verification and validation testing demonstrates that LiverMultiScan is substantially equivalent to, and performs at least as safely and effectively as the listed predicate device. LiverMultiScan meets requirements for safety and effectiveness and does not introduce any new potential safety risks. #### 12. Mechanical and Acoustic Testing Not applicable as the LiverMultiScan (LMSv2) device is standalone software. #### 13. Animal Study Animal performance testing was not required to demonstrate safety and effectiveness of the device. #### 15. Benchtop Performance Data Please see Phantom and Substantial Equivalence sections under Performance Data. #### 14. Clinical Studies Please see In Vivo and Substantial Equivalence sections under Performance Data. #### 15. Conclusion In conclusion, Perspectum Diagnostics Ltd is of the opinion that: - 1 the subject device LiverMultiScan (LMSv2) performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicate, LiverMultiScan (LMSv1) - G the subject device LiverMultiScan (LMSv2) is as safe and effective as the predicate device LiverMultiScan (LMSv1); - C the subject device LiverMultiScan (LMSv2) does not raise new questions of safety and effectiveness; and - the subject device LiverMultiScan (LMSv2) is substantially equivalent to the currently marketed predicate device LiverMultiScan (LMSv1).