(279 days)
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.
Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs.
The provided documentation describes the CoverScan v1 device, which is a medical image management and processing software. While it mentions internal verification and validation testing, and that product specifications were met, it does not explicitly state specific quantitative acceptance criteria or detailed results of a study proving the device meets those criteria, especially in a comparative effectiveness context (MRMC).
The document primarily focuses on establishing substantial equivalence to predicate devices through a qualitative comparison of intended use, technological characteristics, and performance features. It indicates that "bench testing included functional verification to ensure software installation, licensing, labeling, and feature functionality all met design requirements" and that "The accuracy and precision of device measurements was assessed using purpose-built phantoms and in-vivo acquired data from volunteers." However, it does not provide the specific quantitative results of these assessments against defined acceptance criteria.
Therefore, much of the requested information cannot be directly extracted from the provided text. I will explain what information is available and highlight what is missing.
Here's an attempt to structure the information based on the provided text, with clear indications where the information is not present:
Acceptance Criteria and Device Performance Study (CoverScan v1)
The provided document indicates that CoverScan v1 underwent internal verification and validation testing to confirm it met product specifications and its overall ability to meet user needs was validated. However, specific, quantitative acceptance criteria for metrics like accuracy, sensitivity, specificity, etc., are not explicitly defined in the provided text. Similarly, the reported numerical device performance against such criteria is not detailed. The document broadly states that "The accuracy and precision of device measurements was assessed using purpose-built phantoms and in-vivo acquired data from volunteers."
Missing Information: A detailed table of acceptance criteria with numerical targets and the corresponding reported device performance values.
1. A table of acceptance criteria and the reported device performance
| Metric / Category | Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) | Source/Test Type |
|---|---|---|---|
| Accuracy of measurements (cT1, T1, PDFF, T2) | Not explicitly defined in the document | "Assessed using purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for cT1, T1 and PDFF." "Inter and intra operator variability was also assessed." | Bench testing, Phantom studies, In-vivo volunteer data |
| Precision of measurements | Not explicitly defined in the document | "Assessed using purpose-built phantoms... To assess the precision of CoverScan v1 measurements across supported scanners, in-vivo volunteer data was used." | Bench testing, Phantom studies, In-vivo volunteer data |
| Functional Verification | "Software installation, licensing, labeling, and feature functionality all met design requirements." | "Bench testing included functional verification to ensure software installation, licensing, labeling, and feature functionality all met design requirements." | Bench testing |
| Stress Testing | "System as a whole provides all the capabilities necessary to operate according to its intended use." | "All of the different components of the CoverScan software have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use." | Stress testing |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: The document mentions "in-vivo acquired data from volunteers" and that "Volunteers participating in the performance testing were representative of the intended patient population." However, the specific number of cases or volunteers used in the test set is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only mentions "in-vivo acquired data from volunteers," implying prospectively collected data for assessment, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The text indicates that the device produces quantitative metrics that are "interpreted by a licensed physician" to "assist in diagnosis, clinical management and monitoring of patients." However, it does not describe how ground truth was established for the performance testing, nor the number or qualifications of experts involved in that process.
4. Adjudication method for the test set
This information is not provided in the document. There is no mention of an adjudication process (e.g., 2+1, 3+1, none) for the test set's ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not indicate that a MRMC comparative effectiveness study was performed. The device is described as a "post-processing software system" that provides "quantified metrics" and does not describe AI assistance for human readers in a diagnostic workflow. The primary method of performance assessment mentioned is the accuracy and precision of the measurements themselves using phantoms and volunteer data, not reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described involves the device generating quantitative metrics. The phrase "The accuracy and precision of device measurements was assessed" suggests a standalone performance assessment of the algorithm's output (measurements) against some reference (phantoms, in-vivo data). While the final interpretation is by a physician, the core performance reported relates to the device's ability to produce these measurements consistently and accurately, which aligns with a standalone assessment of the algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "accuracy and precision of device measurements" was established using:
- Purpose-built phantoms: These phantoms "containing vials with different relaxation times corresponding to the physiological ranges of tissue values." This provides a known, controlled physical ground truth.
- In-vivo acquired data from volunteers: For this type of data, the text does not specify how ground truth was established (e.g., through other validated methods, clinical outcomes, or expert consensus on a final diagnosis based on all available information). It only mentions that the studies "covering a range of physiological values for cT1, T1 and PDFF."
8. The sample size for the training set
This information is not provided in the document. The document describes CoverScan v1 as software that takes acquired MR data and processes it; it does not detail any machine learning training processes or associated datasets.
9. How the ground truth for the training set was established
As there is no mention of a specific training set in the provided text, the method for establishing its ground truth is also not described. The document implies that the device is a measurement and processing tool rather than a machine learning model that requires a dedicated training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text.
Perspectum Ltd. % Ioan Wigley Head of Regulatory Affairs 5520 John Smith Drive Oxford. Oxfordshire OX4 2LL United Kingdom
Re: K212565
Trade/Device Name: CoverScan v1 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 14, 2022 Received: April 15, 2022
Dear Ioan Wigley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
May 19, 2022
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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 (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,
For
Thalia T. Mills, Ph.D. Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212565
Device Name CoverScan v1
Indications for Use (Describe)
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
| 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/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. The logo also has a small "R" in a circle in the upper right corner.
Date Prepared:
16th of May 2022
Submitter Details
Owner Address:
Perspectum Ltd Gemini One, 5520 John Smith Drive, Oxford Business Park, Oxford, OX4 2LL +44 (0) 1865 655329
| Owner/Operator Number: | 10056574 |
|---|---|
| Establishment Registration Number: | 3014232555 |
| Contact Person: | loan Wigleyioan.wigley@perspectum.com+44 (0) 1865 655329 |
Subject and Predicate Device
| Subject Device | Primary Predicate Device | Predicate Device | |||
|---|---|---|---|---|---|
| No. 2 | No. 3 | No. 4 | |||
| 510(k) number | Not known | K152602 | K190017 | K141480 | K101342 |
| Legal Manufacturer | Perspectum Ltd. | Olea Medical | Perspectum Ltd. | Circle | Pixmeo Sarl |
| Owner/Operator Number | 10056574 | Not known | 10056574 | 3007301305 | 3012516536 |
| Device Name | CoverScan v1 | Olea Sphere V3.0 | LiverMultiScan(LMSv3) | Cvi42 v5.11 | Osirix MD |
| Proprietary/Common name | CoverScan | Olea Sphere V3.0 | LiverMultiScan | Cvi42 | Osirix MD v12.0 |
| 510k Review Panel | Radiology | Radiology | Radiology | Radiology | Radiology |
| Regulation Number | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.2050 |
| Risk Class | Class II | Class II | Class II | Class II | Class II |
| Product Class code | LLZ | LLZ | LNH | LLZ | LLZ |
| Classification | Picture ArchivingCommunicationsSystem | Picture ArchivingCommunicationsSystem | System, NuclearMagnetic ResonanceImaging | Picture ArchivingCommunicationsSystem | Picture ArchivingCommunicationsSystem |
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Subject Device Description
Device Description
CoverScan is a post-processing software system comprised of several software modules. It uses acquired MR data to produce metrics of quantified tissue characteristics of the heart, lungs, liver, kidneys, pancreas and spleen.
Metrics produced by CoverScan can be used by licensed physicians in a clinical setting for the purposes of assessing multiple organs.
Intended Use & Indications for Use
CoverScan is a medical image management and processing software package that allows the display, analysis and postprocessing of DICOM compliant medical images and MR data.
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
CoverScan provides measurements in different organs to be used for the assessment of longitudinal and transversal relaxation time and rate (T1, SR-T1, T2), fat content (proton density fat fraction or PDFF) and metrics of organ function (e.g., left ventricular ejection fractional area change on deep inspiration).
These metrics derived from the interpreted by a licensed physician, vield information that may assist in diagnosis, clinical management and monitoring of patients.
CoverScan is not intended for asymptomatic screening. This device is intended for use with Siemens 1.5T MRI scanners.
Contraindications
CoverScan is indicated for use where MRI is not contraindicated.
Intended Conditions
CoverScan is not intended to be used for use on any specific disease or condition, but the information provided in the report, when interpreted by a licensed physician, may benefit the clinical management, including diagnosis and monitoring of patients.
Standalone Software
CoverScan is a post-processing software device. All operations and features are directly controlled by the CoverScan device. CoverScan does not control other firmware or software outside of the device.
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Image /page/5/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a circular logo that is divided into four colored sections: yellow, blue, green, and pink. There is a small registered trademark symbol in the upper right corner of the logo.
Subject and Predicate Comparison
Subject and Predicate Device Comparison
The following characteristics were compared between the predicate devices in order to demonstrate substantial equivalence.
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| CoverScan (Subject device) | Sphere V3.0 (PrimaryPredicate) | LiverMultiScan (LMSv3)(Predicate Device No. 2) | Cvi42 (Predicate DeviceNo. 3) | Osirix MD (PredicateDevice No. 4) | |
| Product Code | LLZ | LLZ | LNH | LLZ | LLZ |
| Regulation Number | 892.2050 | 892.2050 | 892.1000 | 892.2050 | 892.2050 |
| Class | II | II | II | II | II |
| Intended Use &Indications for Use | CoverScan is a medical imagemanagement and processingsoftware package that allowsthe display, analysis and post-processing of DICOMcompliant medical images andMR data. | Olea Sphere V3.0 is an imageprocessing software packageto be used by trainedprofessionals including but notlimited to physicians andmedical technicians. Thesoftware runs on a standard'off-the-shelf' workstation andcan be used to perform imageviewing, processing, imagecollage and analysis of medicalimages. Data and images areacquired through DICOMcompliant imaging devices andmodalities. | LiverMultiScan (LMSv3) isindicated for use as amagnetic resonancediagnostic device softwareapplication for non-invasiveliver evaluation that enablesthe generation, display andreview of 2D magneticresonance medical image dataand pixel maps for MRrelaxation times. | Cvi42 vascular analysis add-on is an image analysissoftware package add-onfor evaluating CT and MRimages of blood vessels. | Osirix MD is a softwaredevice intended forviewing of imagesacquired from CT, MR,CR, DR, US and otherDICOM compliantmedical imaging systemswhen installed onsuitable commercialstandard hardware.Images and data can becaptured, stored,communicated,processed and displayedwithin the system and oracross computernetworks at distributedlocations. |
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Perspectum (
Characteristic
Subject and Predicate Device(s) Comparison
CoverScan provides both viewing and analysis capabilities to ascertain quantified metrics of multiple organs such as the heart, lungs, liver, spleen, pancreas and kidney.
Olea Sphere V3.0 provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a MRI (DWI) / Fiber Tracking Module and a Dynamic Analysis Module (e.g., dynamic exogenous or endogenous contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion weighted MRI data.
The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system
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.
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| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| The Dynamic Analysis Moduleis used for visualization andanalysis of dynamic imagingdata, showing properties ofchanges in contrast whilerepeating acquisitions (e.g.over time with or withoutvariable acquisitionparameters) where suchtechniques are useful ornecessary.This functionality is referred toas:Perfusion Module – thecalculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. | ||
| Permeability Module – thecalculation of parametersrelated to leakage of injectedcontrast material fromintravascular to extracellularspace. |
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Perspectum
Characteristic
Subject and Predicate Device(s) Comparison
CoverScan provides measurements in different organs to be used for the assessment of fibrosis and/or inflammation of an organ (T1, SR-T1, cT1, T2), fat content (proton density fat fraction or PDFF) and/or some metrics of organ function (e.g., left ventricular ejection fraction and lung fractional area change on deep inspiration).
Arterial Spin Labeling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.
Relaxometry Module - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate.
Metabolic Module – the calculation of parameters related to the fat signal fraction based on a MR technique using opposedphase imaging.
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 threepoint Dixon methodology.
Combining digital image process and visualisation tools such as multiplanar reconstruction (MRP)|, thin/thick maximum intensity projection (MIP) thin and thick, inverted thin and thick, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centreline calculation, lumen calculation stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software
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Perspectum
Characteristic
Subject and Predicate Device(s) Comparison
These metrics derived from the images, when interpreted by a licensed physician, yield information that may assist in diagnosis, clinical management and monitoring of patients.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
package is designed to support the physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesion.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. Cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted, however, image acquisition by a cardiac CT or MR scanner may limit the use
Lossy compressed mammographic images and digitised film screen images must not be viewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. It is the users responsibility to ensure monitor quality, ambient light conditions, and image compression
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| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| CoverScan is not intended forasymptomatic screening. Thisdevice is intended for use withSiemens 1.5T MRI scanners. | of the device for certainsectors of the generalpublic. | ratios are consistent withthe clinical application. | |||
| Limitations of Use | Indicated where MRI is notcontraindicated. | Lossy compressedmammographic images anddigitized film screen imagesmust not be reviewed forprimary image interpretations. | Indicated where MRI is notcontraindicated. | Patients suitable toundergo an MRI or CT scannot contra-indicated forMRI or CT. | Lossy compressedmammographic imagesand digitised film screenimages must not beviewed for primarydiagnosis or imageinterpretation. Forprimary diagnosis, postprocess DICOM “forpresentation” imagesmust be used.Mammographic imagesshould only be viewedwith a monitor approvedby FDA for viewingmammographic images.It is the usersresponsibility to ensuremonitor quality, ambientlight conditions, and |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| ratios are consistent withthe clinical application. | |||||
| Device Users | Trained Perspectum internaloperators. | The main users of the programare medical imagingprofessionals who need tovisualize and analyse imagesacquired primarily with MRI orCT systems. | Trained Perspectum internaloperator. | Qualified medicalprofessionals, experiencedin examining and evaluatingcardiovascular CT or MRimages | No restriction on users.Osirix MD is distributeddirectly from thecompany website. |
| Use Environment | Installation of Modules 1-3 ofCoverScan are installed ongeneral purpose workstationsat Perspectum's imageanalysis centre by specialistmembers of staff.Workstations need to meetthe minimum technicalrequirements. | Olea Sphere is for use inhospitals, imaging centres,radiologist reading practicesby a professional who requiresand is granted access topatient image, demographicand report information. | Installation of LMSv3 iscontrolled and is installed ongeneral purpose workstations.Workstations need to meetthe minimum technicalrequirements. LMSv3 isinstalled on workstations atPerspectum's image analysiscentre by specialist membersof staff. | Cvi42 is a softwareapplication that can beused as a stand-aloneproduct or in a networkedenvironment. | Installation of Osirix MDis controlled and isinstalled on generalpurpose workstations orin a networkedenvironment.Workstations need tomeet the minimumtechnical requirements. |
| Module 4-6 of CoverScan ishosted on Amazon WebServices (AWS) there is nouser interface for thesemodules. | |||||
| Clinical Setting | CoverScan is a software devicethat is intended to be installedon general workstations at | Installed on PC's at the clinicalsite. | LMSv3 is a standalonesoftware device that isintended to be installed on | Cvi42 is a softwareapplication that can beused as a stand-alone | Installation of Osirix MDis controlled and isinstalled on general |
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| Characteristic | Subject and Predicate Device(s) Comparison | ||
|---|---|---|---|
| Perspectum's image centre.The intended device users willlog on to the workstations,access the device, and use thedevice on general-use HDmonitors. | general use workstations atPerspectum's image analysiscentre. The intended deviceusers will log on to theworkstations, access thedevice, and use the device ongeneral-use HD monitors. | ||
| CoverScan is a post-processingsoftware, the intended deviceusers are trained Perspectuminternal operators. Operatorsuse CoverScan to conductquantitative analysis of tissuecharacteristics and function toproduce a quantitative report. | LMSv3 is a post-processingsoftware, the intended deviceusers are trained Perspectuminternal operators. Operatorsuse LMSv3 to conductquantitative analysis of livertissue characteristics toproduce a report. | Cvi42 is a post-processingsoftware, intended deviceusers are qualified medicalprofessionals. Users usemay use cvi42 to conductquantitative analysis toproduce a clinical report. | Osirix MD is a post-processing software.Images and data can becaptured, stored,communicated,processed and displayedwithin the system or in anetworked environment.Osirix MD can exportDICOM files to CD/DVDor USB sticks, including astand-alone cross-platform viewer todisplay the images.It is possible to printdirectly from DICOMprinters images derivedfrom Osirix MD. |
| The end-users for the outputfrom the device, the report,are clinicians who receive andinterpret reports. | The end-users for the outputfrom the device, the report,are clinicians who receive andinterpret LMSv3 reports. | The end-users for theoutput from the device, thereport, are clinicians whoreceive and interpretreports. |
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| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| Principles ofOperation | CoverScan offerscomprehensive functionalityfor image analysis andvisualisation, CoverScancontains multiple modules forthe quantitative analysis oftissue characteristics andfunction. Visualisation andquantification tools for imageanalysis depend on themodule.Module 1 (Liver module)cT1Full segmentation of theouter liver contour andliver vasculature of thecT1 parametric map. ROI placed method on thecT1 map with IQR andmedian metrics from theplaced ROIs potentiallyacross multiple acquiredslices. | The Olea Sphere softwareoffers comprehensivefunctionality for dynamicimage analysis andvisualization, where signalchanges over time areanalysed to determine variousmodality dependentfunctional parameters.Olea Sphere provides bothviewing and analysiscapabilities of functional anddynamic imaging datasetsacquired with MRI or otherrelevant modalities, includingdiffusion weighted MRI (DWI)/ fiber tracking, and dynamicanalysis (e.g. dynamicexogenous or endogenouscontrast enhanced imagingdata for MRI and CT).DWI / Fiber Tracking Module:Diffusion analysis is used tovisualize local water diffusion | Allows for the visualisation viaparametric maps andquantification of metrics (cT1,T2* and PDFF) from livertissue and exportation ofresults & images to adeliverable report.LMSv3 allows for:cT1 Full segmentation of theouter liver contour andliver vasculature of thecT1 parametric map. IQRand median metrics arereported from thesegmentation. ROI placed method on thecT1 map with IQR andmedian metrics from theplaced ROI's potentially | Cvi42 contains multiplemodules for the analysis ofblood vessels derived fromCT and MR images.Visualisation andquantification tools forimage analysis depend onthe use case. When usedfor the analysis of cardiacimages the followingmodules are available: | Osirix MD is a post-processing software.Images and data can becaptured, stored,communicated,processed and displayedwithin the system or in anetworked environment |
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| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| 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 ROIs potentially across multiple acquired slices PDFF parametric maps are calculated using the LMS IDEAL method (1) | diffusion weighted MRI data.Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system.Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging, showing properties of changes in contrast while repeating acquisitions (e.g. over time with or without variable acquisition parameters) where such techniques are useful or necessary. | 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 or DIXON method (1). |
| Module 2 (Pancreas module)SR-T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially | This functionality includes dedicated analysis methods and visualization tools for dynamic contrast enhanced imaging data (from MRI or CT) where a bolus injection of a contrast agent material results | T2* ROI placed method on the T2* map with IQR and median metrics from the placed ROI's potentially across multiple acquired slices. |
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| Characteristic | Subject and Predicate Device(s) Comparison | |||
|---|---|---|---|---|
| across multiple acquired slices The calculation of pancreas T1 maps using the MultiScan module uses the signal from supported scanners and MRI field strengths to simulate the data as it would be acquired on the reference scanner, providing improved reproducibility. The SR-T1 pipeline maps MRI-system dependent T1 images to MRI-system independent SR-T1 images and that allows comparison of SR-T1 values over a wide variety of MRI systems | in a temporal change in the signal intensity. This dynamic change in signal intensity is used to calculate functional parameters related to tissue flow (perfusion) and tissue blood volume as well as leakage (due to capillary permeability) of the injected contrast material from the intravascular to the extracellular space.This functionality is referred to as:Perfusion Module: Calculation of parameters related to tissue flow (perfusion) and tissue blood volume. | T2* parametric maps are calculated from the DIXON method (2) | ||
| PDFF ROI placed method on the PDFF map with IQR and median metrics from the placed ROIs potentially | Permeability Module:Calculation of parameters related to leakage of injected contrast material from | |||
| Characteristic | Subject and Predicate Device(s) Comparison | |||
| across multiple acquired slicesPDFF parametric maps are calculated using the LMS IDEAL method (1) Module 3 (Kidney module) | intravascular to extracellular space. | |||
| T1 ROI placed method on the T1 map with IQR and median metrics from the placed ROIs potentially across multiple acquired slices | This functionality also includes dedicated analysis methods and visualization tools for MR technique using the water in arterial blood as endogenous tracer to visualize tissue perfusion and evaluate blood flow non-invasively. This functionality is referred to as:Arterial Spin Labelling (ASL) Module – the calculation of parameters related to tissue flow based on a MR technique using the water in arterial blood as endogenous tracer to evaluate the perfusion.This functionality also includes dedicated analysis methods and visualization tools for MR technique using intrinsic tissue properties to visualize and evaluate tissue relaxation times and fat signal fraction. This functionality is referred to as: |
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| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| Relaxometry Module – thecalculation of parametersrelated to the MR longitudinaland transversal relaxationtime and rateMetabolic Module – thecalculation of parametersrelated to the fat signalfraction based on a MRtechnique using opposed-phase imaging. | Short Axis 3D Module | |
| Module 4 (Cardiac functionmodule)Operators may use moduleswithin CoverScan to analyseand quantify cardiac imageswith the below capabilities:Left Ventricular function• Ejection fraction• End Diastolic Volume – leftventricle• End Systolic Volume – leftventricle• Stroke Volume• Left Ventricle Muscle Mass | Left Ventricular function• Ejection fraction• End Diastolic Volume –left ventricle• End Systolic Volume – leftventricle• Stroke Volume• Left Ventricle MuscleMass• Left Ventricular WallThickness• Global and regional LVfunction and volumeanalysis | |
| Characteristic | Subject and Predicate Device(s) Comparison | |
| • Left Ventricular WallThicknessT1 mapping ModuleAssessment of native T1Relaxation times T1, T1*and R2maps with customizable colorLUT and polar map display | • Global RV functionanalysisT1 mapping Module• Assessment of native andpost contrast T1Relaxation times T1,T1*and R2 maps withcustomizable colour LUTand polar map display• Assessment of ECV % perslice and segmentincluding polar mapdisplay and mapgeneration withcustomizable colour LUT | |
| T2 Mapping ModuleAssessment of segmental T2times. | T2 Mapping ModuleGlobal and RegionalSegmental T2 times | |
| Module 5 (Lung)Basic calculations todetermine the percentage | Viewing• Zooming, rotating,panning and scrolling | |
| Characteristic | Subject and Predicate Device(s) Comparison | |
| change in area from inspiration to expiration from datasets exported from analysis conducted in Osirix MD. | ROI (Region-Of-Interests) tools are available to measure angles, surfaces, distances, densities, SUV, Cobb angle, volumes Extract statistical data on 2D or 3D ROI Image fusion for reviewing PET-CT, PET-MR and SPECT-CT Ejection Fraction calculation, Growing Region tool Post-processing 3D rendering tools, such as Multiplanar Reconstructions, Curved Reconstructions, 3D Volume Rendering, 3D Surface Rendering 3D sculpting tools Measure distance in 3D Volume Rendering, 3D Curved-MPR or 3D Orthogonal MultiPlanar |
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| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| Module 6 (Metricconsolidation)A compiled clinical reportcontaining metrics frommodules 1-5, rounding ofthese numbers along with areference range. | Reporting Module• Viewing of compiledclinical report• Send and/or save report | • 3D rigid registrationPost-processingtechniques such asMPR (MultiplanarReconstruction), 3DRendering (MIP,Volume Rendering andSurface Rendering). | |||
| PerformanceFeatures | Main software features:• Post-processing, displayand allow manipulation ofmedical MR images• Image loading and saving• Session file loading andsaving• Image viewing• Image manipulation• Image analysis• Image processing | Main software features:• Image Loading & Saving• Image Viewing• Image Manipulation• Image Analysis• Imaging Processing• Perfusion post-processing• Permeability post-processing• Kinetics post-processing• Arterial spin labelling | Main software features:• Image loading and saving• Session file loading andsaving• Image viewing• Image manipulation• Image analysis• Image processing• Relaxometry post-processing | Main software features:• Receive, store, transmit,post process, displayand allow manipulationof medical MR and CTimages• Clinical serverfunctionality• Visualisation in 2D, 3Dand 4D of single ormultiple datasets | Main software features:• Image Loading &Saving• Image Viewing• Image Manipulation• Image Analysis• Imaging Processing |
| Characteristic | Relaxometry post-processing Fat fraction post-processing Segmentation of regions of interest | Diffusion Weighted Imaging / Tensor Imaging postprocessing / Intra-Voxel Incoherent Motion Fiber Tracking post-processing Collage (composing) Relaxometry post-processing Metabolic postprocessing | Fat-fraction post-processing Segmentation of regions of interest | Define and edit paths through structures such as centrelines Analysis of cross references of structures Fly-through visualisation Segmentation of regions of interest Quantitative analysis including, distance, angle, volume, histogram, and tracking quantities over time Derive metadata or new images from input image sets Creating/forwarding DICOM images DICOM compliant | |
| Design: MR Relaxometry | Relaxometry post-processing (T1, T2 and T2*), and subsequently cT1 and SR-T1. | Relaxometry (for MR imaging) - the calculation of parameters related to the MR longitudinal and transversal relaxation time and rate. | Relaxometry post-processing (cT1 and T2*) | Relaxometry post-processing (T1*, T1 and T2) | N/A |
| Design: Liver Fat Quantification | Fat fraction postprocessing (PDFF) | Metabolic (for MR imaging) - the calculation of parameters related to the fat signal fraction based on a MR | Fat fraction post-processing (PDFF) | N/A | N/A |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| technique using opposed-phase imaging (otherwise known as PDFF). | |||||
| Design: Parametric Maps | An operator can use modules 1-3 of CoverScan to generate T2*, T2 and T1 relaxometry maps fitted from an appropriate set of MR Inversion Recovery images which are Gradient Echo (GRE) and MOLLI acquisition protocols respectively. Modules within CoverScan may also be used to generate fat signal fraction (PDFF) maps calculated from an appropriate set of MR GRE images using the IDEAL (iterative decomposition of water and fat with echo asymmetric and least-squares estimation) methodology (13). Module 5 within CoverScan can be used to calculate percentage change in area from inspiration to expiration | Olea Sphere V3.0 allows the display, analysis and post-processing of medical images. These images, when interpreted by a trained physician, may yield clinically useful information. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive dynamic image processing and display. Depending on the purpose of the imaging, the following optional plug-in are used by the software:• Metabolic (for MR imaging) - the calculation of parameters related to the fat signal fraction based on a MR technique | An operator can use LMSv3 to generate T1 maps fitted from an appropriate set of MR Inversion Recovery images which are Gradient Echo (GRE) and MOLLI acquisition protocols, acquired from supported MR Systems. The T1 mapping uses a model of MR physics shown in (3). Multiple image signal measurements are for a number of different inversion times. Fitting the model to these measurements on a pixel-by-pixel basis allows an estimation of the pixel-wise T1 values. The three-parameter model fitting is performed using a Nelder-Mead Simplex algorithm (4). LMSv3 utilizes magnetic resonance images that exploit | Cvi42 can be used to receive, store, transmit, post process, display and allow manipulation of medical MR and CT images. An operator may use cvi42 to generate T1 maps fitted from an appropriate set of) acquisition protocols, acquired from MR and CT Systems. Depending on the purpose of the imaging, the following optional plug-in can be used in the software: | Osirix MD is a post-processing software. Images and data can be captured, stored, communicated, processed and displayed. Image maps may be processed using the following tools and capabilities:Post-processing• 3D rendering tools, such as Multiplanar Reconstructions, |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| change using the interfacethat offers tools:3D rendering tools, such asMultiplanarReconstructions, CurvedReconstructions, 3DVolume Rendering, 3DSurface Rendering, 3DEndoscopy 3D sculpting tools Measure distance in 3DVolume Rendering, 3DCurved-MPR or 3DOrthogonal MultiPlanar 3D rigid registration Module 4 within CoverScancan be used to analyse andcalculate cardiac metrics toreport:Left Ventricular function | using opposed-phaseimaging.Relaxometry (for MRimaging) - the calculationof parameters related tothe MR longitudinal andtransversal relaxationtime and rate. | the difference in resonancefrequencies betweenHydrogen nuclei in water andtriglyceride fat. An operatorcan use LMSv3 to generatePDFF maps calculated from anappropriate set of MR GREimages using the IDEAL(iterative decomposition ofwater and fat with echoasymmetric and least-squaresestimation) or three-pointDIXON methodology (13).Iron corrected T1 (cT1), T2*and Proton Density FatFraction (PDFF) parametricmaps can be created from allsupported scanners.It is possible to use the T2*and PDFF maps andknowledge of the T2*measurements and thescanner field strength tocorrect for signal changes | Short Axis 3D ModuleLeft Ventricular function | CurvedReconstructions, 3DVolume Rendering,3D SurfaceRendering, 3DEndoscopy 3D sculpting tools Measure distance in3D VolumeRendering, 3DCurved-MPR or 3DOrthogonalMultiPlanar 3D rigid registration Post-processingtechniques such asMPR (MultiplanarReconstruction), 3DRendering (MIP,Volume Renderingand SurfaceRendering). | |
| Left Ventricular function Ejection fraction End Diastolic Volume – leftventricle End Systolic Volume – leftventricle | Ejection fraction End Diastolic Volume –left ventricle End Systolic Volume – leftventricle Stroke Volume Left Ventricle MuscleMass | ||||
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| Stroke Volume Left Ventricle Muscle Mass Maximum Left VentricularWall Thickness Regional segmental T1times Regional Segmental T2timesT2 Mapping ModuleSegmental T2 times | related to iron deposits,producing a cT1map. The cT1 map eliminatesthe effects of elevated ironfrom the T1 measurement (4)PDFF is quantified using theLMS IDEAL or DIXON method.Parametric maps of T2* iscomputed using the DIXONmethod. | Left Ventricular WallThickness Global and regional LVfunction and volumeanalysis Global RV functionanalysisT1 mapping Module Assessment of native andpost contrast T1Relaxation times T1, T1*and R² maps withcustomizable colour LUTand polar map display Assessment of ECV % perslice and segmentincluding polar mapdisplay and mapgeneration withcustomizable colour LUTT2 Mapping ModuleGlobal and RegionalSegmental T2 times | |||
| Design:Visualisation | Offers numerous views withinmodules 1-5 of the CoverScaninterface can be used to assist | Offers numerous views,dependent on the purpose ofthe imaging, in the interface | Offers numerous views withinthe LMSv3 interface can beused to assist in analysis, Iron- | Offers numerous views,dependant on the purposeof the imaging, in the | Osirix MD offers the 2D,3D and 4D viewing ofmedical images read |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| in analysis, T1, T2* and ProtonDensity Fat Fraction (PDFF))parametric maps can becreated from all supportedscanners. R2 maps can also beutilised to assess the quality ofthe map fitting. Colormaps inthe parametric maps aredesigned to have maximumcontrast on organ tissue. | that can be used to assist inanalysis of relaxometry andmetabolic post-processing. | corrected T1 (cT1), T2* andProton Density Fat Fraction(PDFF)) parametric maps canbe created from all supportedscanners. R2 maps can also beutilised to assess the quality ofthe map fitting. Iron-corrected T1 (cT1) displayedusing LMSv3 colormap,designed to have maximumcontrast on liver parenchymaltissue. | interface that can be usedto receive, store, transmit,post process, display andallow manipulation ofmedical MR and CT images.The interface allows for thevisualisation in 2D, 3D and4D of single or multipledatasets. | from all types of DICOMfiles, produced bymedical imagingmodalities, includingimages produced byscanners, MRI,ultrasounds, or standardX-rays. | |
| Design: Outputteddata | Quantified metrics and imagesderived from the analysis oftissue characteristics andorgan function fromparametric maps that arecollated into a report forevaluation and interpretationby a licensed physician.Quantification is based on theplacement of ROI's (duringanalysis in Modules 1-3), foreach metric. The median andIQR are given as well as a'reference range'. | Information not given. | Quantified metrics and imagesderived from the analysis ofliver tissue characteristic onparametric maps are collatedinto a report for evaluationand interpretation by aclinician.When segmentation analysis isused a representative piechart is provided based on theconfirmed segmentationcontour from the PDFF map.The voxels within thesegmentation are separated | Quantified metrics andimages derived from theanalysis are collated into areport for evaluation andinterpretation by a clinician. | Osirix MD can exportDICOM files to CD/DVDor USB sticks, including astand-alone cross-platform viewer todisplay the images.It is possible to printdirectly from DICOMprinters images derivedfrom Osirix MD. |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| into 5 categories (<5% PDFF,5-10% PDFF, 10-33% PDFF, 33-66% PDFF and >66%) to giveproportions based on PDFF.These categories were chosenbased on the work of Kleineret al (3) and Satkunasinghamet al (4) on the grading ofhistological featurespresented in Non-AlcoholicFatty Liver Disease. Based onthe placed ROI's, for eachmetric the median and IQR aregiven as well as a 'referencerange'. | |||||
| Design: SupportedModalities | DICOM 3.0 compliant MR datafrom supported MRI scanners. | Supports compliant data fromboth CT and MRI. | DICOM 3.0 compliant MR datafrom supported MRI scanners. | Supports compliant datafrom both CT and MRI. | Supports all types ofDICOM files, producedby medical imagingmodalities, includingimages produced byscanners, MRI,ultrasounds, or standardX-rays. |
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
| PerformanceTesting | Perspectum has conductedextensive validation testing ofCoverScan, a medical imagemanagement and processingsystem (MIMPS), that iscapable of providing reliablepost-processing and display ofimages for multi-parametricanalysis.Internal verification andvalidation testing confirmsthat the product specificationsare met.All of the differentcomponents of the CoverScansoftware have been stresstested to ensure that thesystem as a whole provides allthe capabilities necessary tooperate according to itsintended use. | Olea Medical has conductedextensive validation testing ofthe Olea Sphere V3.0 system,as a PACS that is capable ofproviding reliable post-processing and display ofimages for instantaneousmulti-parametric analysis.Internal verification andvalidation testing confirmsthat the product specificationsare met, in support of thesubstantial equivalence of theintended use andtechnological characteristic asthe predicate devices.All of the differentcomponents of the OleaSphere V3.0 software havebeen stress tested to ensurethat the system as a wholeprovides all the capabilitiesnecessary to operateaccording to its intended use. | Internal verification andvalidation testing confirmsthat the product specificationsare met.All of the differentcomponents of the LMSv3software have been stresstested to ensure that thesystem as a whole provides allthe capabilities necessary tooperate according to itsintended use. | Not given | Not given |
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| Characteristic | Subject and Predicate Device(s) Comparison | |
|---|---|---|
| The main groups of tests performed include:Product Risk Assessment Software modules verification tests Software validation test Device performance was assessed with purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for cT1, T1 and PDFF. | The main groups of tests performed include:Product Risk Assessment Software modules verification tests Software validation test Device performance was assessed with purpose-built phantoms and in-vivo acquired data from volunteers covering a range of physiological values for cT1, T2* and PDFF. | |
| Human Factors | Assessed in accordance with IEC 62366 and FDA guidance document 'Applying Human Factors and Usability Engineering to Medical Devices.' | Assessed in accordance with IEC 62366 and FDA guidance document 'Applying Human Factors and Usability Engineering to Medical Devices.' |
| Standards | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485 | IEC 62304, IEC 62366, DICOM 3.0, ISO 14971, ISO 13485 |
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Perspectum
| Characteristic | Subject and Predicate Device(s) Comparison | ||||
|---|---|---|---|---|---|
| System/Operating System | Mac OS | Windows or Linux | Mac OS | Windows or Mac OS | Windows or Mac OS |
| Materials | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Energy Source | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Biocompatibility | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Sterility | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Electrical Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Thermal Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Mechanical Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Radiation Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
| Chemical Safety | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software | Not applicable, post-processing software |
In conclusion, the subject device does not result in an compared to the chosen predicate device and it performs in acordance with its use characteristics and intended use.
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Image /page/30/Picture/1 description: The image shows the word "Perspectum" in a bold, dark gray font. To the right of the word is a colorful circular logo. The logo is divided into four sections, with the top section being yellow, the right section being green, the bottom section being pink, and the left section being blue.
Software and Performance Testing
All product specifications were verified and the overall ability of the product to meet user needs was validated. Testing was performed according to internal company procedures. Software testing and validation were conducted according to written test protocols established before testing was conducted. Software verification and validation testing were conducted, and documentation was provided as detailed in FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for CoverScan v1 is Moderate, as per FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This device does not control a life supporting or life-sustaining device, nor does it control the delivery of a potentially harmful energy. This device does not control the delivery of treatment, and it does not provide diagnostic information, nor does it provide any vital signs monitoring. The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented.
Bench testing included functional verification to ensure software installation, licensing, labeling, and feature functionality all met design requirements. The accuracy and precision of device measurements was assessed using purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values expected to be seen in-vivo. To assess the precision of CoverScan v1 measurements across supported scanners, in-vivo volunteer data was used. Volunteers participating in the performance testing were representative of the intended patient population. Inter and intra operator variability was also assessed.
CoverScan v1 underwent performance testing under controlled conditions to corroborate that it is safe and effective when used as intended. The performance testing conducted demonstrates that CoverScan v1 is at least as safe and effective as the predicate devices.
Conclusion
CoverScan v1 has the same intended use and similar technological characteristics as the primary predicate's devices, Olea Sphere v3.0. CoverScan is comprised of several modules for the multi-organ quantification of metrics derived from tissue and organ characteristics. Additionally, further predicates are used (LiverMultiScan manufactured by Perspectum Ltd, Osirix MD manufactured by Pixmeo SARL, cvi42 manufactured by Circle Cardiovascular Imaging Inc) to corroborate those differences between the devices do not result in a new intended use for CoverScan and do not raise any questions of safety and effectiveness. It can be concluded that CoverScan is substantially equivalent to the listed predicate devices.
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Image /page/31/Picture/1 description: The image shows the logo for Perspectum. The word "Perspectum" is written in a bold, sans-serif font in dark gray. To the right of the word is a circular graphic divided into four colored sections: yellow, blue, green, and pink. There is a registered trademark symbol above and to the right of the yellow section.
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- Andersson A, Dennis A, Kelly M, Imajo K, Nakajima A, Fallowfield J, et al. MRI corrected T1 mapping and liver fat by ഹ PDFF as biomarkers for at-risk non-alcoholic steatohepatitis: A pooled participant data and meta-analysis. Clin Gastroenterol Hepatol. 2021;submitted.
- Beyer C, Hutton C, Andersson A, Imajo K, Nkajima A, Kiker D, et al. Comparison between magnetic resonance and 6. ultrasound-derived indicators of hepatic steatosis in a pooled NAFLD cohort. PLOS ONE. 2020;In press.
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- Dennis A, Kelly M, Fernandes C, Mouchti S, Fallowfield G, et al. Correlations between MRI biomarkers PDFF and cT1 with histopathological features of non-alcoholic steatohepatitis. Front Endocrinol. 2020;11.
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§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).