(120 days)
ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.
The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.
The images created with rigid or elastic registrations, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images.
The contours created automatically, semi-automatically or manually require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
The device is intended to be used in a clinical setting, by trained professionals only.
The ART-Plan application is comprised of two kev modules: SmartFuse and Annotate, allowing the user to display and visualize 3D multi-modal medical image data. The user may process, render, review, store, display and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated CT (computerized tomography), PET (positron emission tomography), and MR (magnetic resonance).
The overview of the product, in terms of input/output, functionalities and integration within the current clinical workflow for radiation therapy planning.
The ART-Plan technical functionalities claimed by TheraPanacea are the following:
- . Proposing automatic solutions to the user, such as an automatic delineation, automatic multimodal image fusion, etc. towards improving standardization of processes/ performance / reducing user tedious / time consuminq involvement.
- . Offering to the user a set of tools to assist semi-automatic delineation, semi-automatic registration towards modifying/editing manually automatically generated structures and addinq/removing new/undesired structures or imposing user-provided correspondences constraints on the fusion of multimodal images.
- . Presenting to the user a set of visualization methods of the delineated structures, and registration fusion maps.
- . Saving the delineated structures / fusion results for use in the dosimetry process.
- . Enabling rigid and deformable registration of patients images sets to combine information contained in different or same modalities.
Here's an analysis of the acceptance criteria and supporting studies for the ART-Plan device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests but does not explicitly state quantitative "acceptance criteria" alongside "reported device performance" in a structured table. Instead, it describes tests performed and their general outcome ("Passed"). The "results" column indicates whether the device met the implicit expectations for each test.
Therefore, I've created a table summarizing the tests described and their reported outcomes, which implicitly serve as the device meeting performance expectations:
| Test Name | Test Description | Reported Device Performance (Implicit Acceptance) |
|---|---|---|
| Usability Testing | Assessment for compliance with IEC 62366. | Passed |
| Autosegmentation performances (European data) | Study gathering information on 3 tests performed on automatic segmentation performances on European data. | Passed |
| Autosegmentation performances according to AAPM requirements | Demonstrated that the auto-segmentation algorithm of the Annotate module provides acceptable contours for the concerned structures on an image of a patient. | Passed |
| Autosegmentation performances against MIM | Demonstrated that the auto-segmentation algorithm of the Annotate module provides acceptable contours for the concerned structures on an image of a patient. | Passed |
| Qualitative validation of autosegmentation performances | Demonstrated that the auto-segmentation algorithm of the Annotate module provides acceptable contours for the concerned structures on an image of a patient. | Passed |
| External Contour performances according to AAPM requirements | Demonstrated that the External Contour Automatic Segmentation algorithm of the Annotate module provides acceptable contours for the patient's body on an image of a patient. | Passed |
| Fusion performances according to AAPM recommendations | Evaluated the quality of the rigid and deformable registration tools of the SmartFuse module on retrospective intra-patient images and inter-patient images of different modalities, to ensure the safety of the device for clinical use. | Passed |
| Registration performances on POPI-model | Evaluated the quality of the deformable registration tools of the SmartFuse module on intra-patient CT images. Testing was conducted according to POPI-model protocol on corresponding public data. | Passed |
| Autosegmentation performances on US data | Demonstrated that the autosegmentation algorithm of the Annotate module provides clinically acceptable contours for the concerned structures when applied to US patients. | Passed |
| Pilot study for sample size estimation - literature review | Pilot study estimating a consistent sample size of dataset for performance testing's considering state-of-art studies in image registration and segmentation. Literature review completed on most cited articles in the field of medical vision. | Passed |
| System Verification and Validation Testing | Verification and validation testing performed to verify the software of the ART-Plan, following FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered a "major" level of concern due to potential for serious injury or death from failure or misapplication. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Autosegmentation performances (European data): The document mentions "3 tests performed on the automatic segmentation performances on European data." No specific sample size (number of patients or images) is given for these tests. The provenance is explicitly stated as European data. The retrospective/prospective nature is not specified, but typically such performance evaluations on existing data are retrospective.
- Autosegmentation performances on US data: This test explicitly states that the algorithm was applied to US patients. No specific sample size (number of patients or images) is provided. The retrospective/prospective nature is not specified.
- Fusion performances according to AAPM recommendations & Registration performances on POPI-model: These studies evaluated various registration qualities. No specific sample size (number of patients or images) is provided for these tests, although the POPI-model test indicates "corresponding public data." The provenance for the AAPM fusion test includes "retrospective intra-patient images and inter-patient images," suggesting retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth for the test sets or their specific qualifications (e.g., "radiologist with 10 years of experience").
It does mention that the device's output (contours created automatically, semi-automatically, or manually) "require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy." This implies that qualified professionals are expected to review and validate results, which is a key part of the human-in-the-loop workflow. However, this is about clinical use, not the ground truth generation for the performance studies themselves.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth of the test sets in the performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not explicitly mentioned or described in the provided non-clinical testing section. The studies focus on the standalone performance of the AI algorithms (autosegmentation, fusion).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone performance studies were done. The "Autosegmentation performances" tests, "External Contour performances," "Fusion performances," and "Registration performances" all evaluate the algorithm's output directly. The device description explicitly states it is a software designed "to assist the contouring process," and the contours generated "require verifications, potential modifications, and then the validation of a trained user." This confirms that the AI provides an initial output (standalone performance) that is then subject to human review.
7. The Type of Ground Truth Used
The document refers to the AI providing "acceptable contours" or "clinically acceptable contours." While it doesn't explicitly state the method of ground truth generation (e.g., expert consensus, pathology, outcomes data), the context of "acceptability" for radiotherapy planning strongly implies that the ground truth for these contoured structures would be established by expert consensus (likely radiation oncologists or dosimetrists) or highly correlated with clinical consensus/guidelines for radiotherapy planning. Pathology or outcomes data are less likely to be used directly for geometric contour ground truth.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set of the AI models.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
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January 14, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
TheraPanacea % Mr. Edwin Lindsay QA/RA Consultant Pépinière Cochin Paris Santé 29 rue du Faubourg Saint-Jacques Paris. 75014 FRANCE
Re: K202700
Trade/Device Name: ART-Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: December 9, 2020 Received: December 14, 2020
Dear Mr. Lindsay:
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
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202700
Device Name ART-Plan
Indications for Use (Describe)
ART-Plan is a software designed to assist the contouring process of the target anatomical regions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.
The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.
The images created with rigid or elastic registrations, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the organs at risk and healthy lymph nodes on CT images.
The contours created automatically, semi-automatically or manually require verifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
The device is intended to be used in a clinical setting, by trained professionals only.
| 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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510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
TheraPanacea
Submitter's Address:
Pépinière Cochin Paris Santé 29 rue du Faubourg Saint-Jacques 75014 Paris France
Telephone: +33 9 62 52 78 19
Establishment Registration Number:
Still to be established
Contact Person:
Edwin Lindsay
Telephone +44 (0) 7917134922
Date Prepared:
7th September 2020
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Below summaries the Device Classification Information regarding the TheraPanacea ART-Plan:
Primary Product Code:
| RegulationNumber | Device | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 892.2050 | Medical device software,radiology | Class 2 | QKB | Radiology |
Device Trade Name:
ART-Plan
Device Common Name:
ART-Plan
Intended/ Indications Use:
ART-Plan is a software designed to assist the contouring process of the target anatomical reqions on 3D-images of cancer patients for whom radiotherapy treatment has been planned.
The SmartFuse module allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison and delineation of image data by the user.
The images created with rigid or elastic registration require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
With the Annotate module, users can edit manually and semi-automatically the contours for the regions of interest. It also allows to generate automatically, and based on medical practices, the contours for the orqans at risk and healthy lymph nodes on CT images.
The contours created automatically, semi-automatically or manually require verifications, potential modifications, and then the validation of a trained user with professional qualifications in anatomy and radiotherapy.
The device is intended to be used in a clinical setting, by trained professionals only.
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Summary of Substantial Equivalence:
The following predicate devices have been that the ART-Plan can claim equivalence with and these are detailed below
General Comparison
| General Information | |||||||
|---|---|---|---|---|---|---|---|
| Property | Proposed DeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| CommonName | Radiologicalimage processingsoftware forradiation therapy | Radiologicalimage processingsoftware forradiation therapy | System, imageprocessing,radiological | System, imageprocessing,radiological | System, image processing,radiological | N/A | |
| DeviceManufacturer | TheraPanacea | Xiamen ManteiaTechnology LTD | Mirada Medical Ltd. | Mirada Medical Ltd. | MIMvista Corp (now MIM SoftwareInc) | N/A | |
| 510k | N/A | K191928 | K130393 | K181572 | K071964 | N/A | |
| DeviceClassification | II | II | II | II | II | N/A | |
| PrimaryProductCode | QKB | QKB | LLZ | LLZ | LLZ | As advised by the FDA the newproduct code, QKB, has beencreated in-lieu of LLZ which usesAl algorithms and is intended forradiation therapy, and is theproposed product code for ART-Plan. | |
| SecondaryProductCode | - | - | - | - | - | N/A | |
| TargetPopulation | Any patient typefor whom relevantmodality scan datais available | Not stated | Any patient type forwhom relevantmodality scan datais available. | Any patient type forwhom relevantmodality scan datais available. | Not stated | The proposed device hasidentical target populations to thesecondary predicates. | |
| Environment | Hospital | Hospital | Hospital | Hospital | Hospital | The proposed device andpredicates have identicaltarget environments | |
| IntendedUse/Indication for | Intended UseART-Plan is asoftware designed | It is used byradiationoncology | Workflow Box is asystem designed toallow users to route | RTx is intended tobe used by trainedmedical | Intended UseMIM 4.1 (SEASTAR) software isintended for trained medical | The intended use andindications for use of theproposed device, ART-Plan | |
| General Information | |||||||
| Property | Proposed DeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| Use | to assist thecontouringprocess of thetargetanatomicalregions on 3D-images of cancerpatients for whomradiotherapytreatment hasbeen planned.The SmartFusemodule allows theuser to registercombinations ofanatomical andfunctional imagesand display themwith fused andnon-fused displaysto facilitate thecomparison anddelineation ofimage data by theuser.The imagescreated with rigidor elasticregistration requireverifications,potentialmodifications, andthen the validationof a trained userwith professionalqualifications inanatomy andradiotherapy.With the Annotatemodule, users can | department toregistermultimodalityimages andsegment (non-contrast) CTimages, togenerate neededinformation fortreatmentplanning,treatmentevaluation andtreatmentadaptation. | DICOM-compliantdata to and fromautomatedprocessingcomponents.Workflow Boxincludes processingcomponents forautomaticallycontouring imagingdata usingdeformable imageregistration andmachine learningbased algorithms.Workflow Box mustbe used inconjunction withappropriatesoftware to reviewand edit resultsgeneratedautomatically byWorkflow Boxcomponents, forexample imagevisualizationsoftware must beused to facilitate thereview and edit ofcontours generatedby Workflow Boxcomponentapplications.Workflow Box is notintended toautomatically detectlesions. | professionalsincluding, but notlimited to,radiologists, nuclearmedicinephysicians,radiationoncologists,dosimetrists andphysicists.RTx is a softwareapplication intendedto display andvisualize 2D & 3Dmulti-modal medicalimage data. Theuser may process,render, review,store, print anddistribute DICOM3.0compliant datasetswithin the systemand/or acrosscomputer networks.Supportedmodalitiesinclude static andgated a, PET, MR,SPECT and planarNM. The user mayalso create, display,print, store anddistribute reportsresulting frominterpretation of thedatasets.RTx allows the userto registercombinations of | professionals including, but notlimited to, radiologists,oncologists, physicians, medicaltechnologists, dosimetrists andphysicists.MIM 4.1 (SEASTAR) is amedical image and informationmanagement system that isintended to receive, transmit,store, retrieve, display, print andprocess digital medical images,as well as create, display andprint reports from those images.The medical modalities of thesemedical imaging systemsinclude, but are not limited to,CT, MRI, CR, DX, MG, US,SPECT, PET and XA assupported by ACR/NEMADICOM 3.0.MIM 4.1 (SEASTAR) providesthe user with the means todisplay, register and fusemedical images from multiplemodalities. Additionally, itevaluates cardiac left ventricularfunction and perfusion, includingleft ventricular end-diastolicvolume, end-systolic volume,and ejection fraction. TheRegion of Interest (ROI) featurereduces the time necessary forthe user to define objects inmedical image volumes byproviding an initial definition ofobject contours. The objectsinclude, but are not limited to,tumors and normal tissues. | and the primary predicateAccuContour are the same inthat they are softwareapplications intended forprofessional use todisplay and visualize multi-modal medical image data.Supported modalities includeCT, PET, and MR.The proposed device is alsoidentical to the primarypredicate in that it offers thesame two key features of theplanning process inradiotherapy: imageregistration andsegmentation.In both devices, segmentationcan only be performed on CTmodality; registration can bedone from every supportedmodality toward a CT withdeformable registration.The proposed device maydiffer from the primarypredicate in a) the list ofstructures included inautomatic segmentationalgorithm b) the presence ornot of a rigid registrationalgorithm, which is areduction compared to thedeformable registration that isprovided by ART-Plan.However, not enoughinformation on these twoaspects is provided on the | |
| Property | Proposed DeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | Secondary PredicateWorkflow Box | General InformationSecondary PredicateMIM4.1 (SEASTAR) | Comment | |
| edit manually andsemi-automaticallythe contours forthe regions ofinterest. Italso allows togenerateautomatically, andbased on medicalpractices, thecontours for theorgans at risk andhealthy lymphnodes on CTimages.The contourscreatedautomatically,semi-automaticallyor manuallyrequireverifications,potentialmodifications, andthen the validationof a trained userwith professionalqualifications inanatomy andradiotherapy.The device isintended to beused in a clinicalsetting, by trainedprofessionals only. | anatomical andfunctional imagesand displaythem with fused andnon-fused displaysto facilitate thecomparison ofimage data by theuser. The result ofthe registrationoperation can assistthe user inassessing changesin imagedata; either within orbetweenexaminations andaims to help theuser obtain a betterunderstanding ofthe combinedinformation thatwould otherwisehave to be visuallycompareddisjointedly.RTx provides anumber of toolssuch as rulers andregion of interests,which are intendedtobe used for theassessment ofregions of an imageto support a clinicalworkflow. Examplesofsuch workflowsinclude, but are not | MIM 4.1 (SEASTAR) providestools to quickly create,transform, and modifycontours for applicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systems andarchiving contours for patientfollow-up and management.MIM 4.1 (SEASTAR) also aidsin the assessment ofPET/SPECT brain scans. Itprovides automated quantitativeand statistical analysis byautomatically registeringPET/SPECT brain scans to astandard template andcomparing intensity values to areference database or to otherPET/SPECT scans on a voxelby voxel basis, withinstereotactic surface projectionsor standardized regions ofinterest.Indications for UseMIM 4.1 (SEASTAR) software isused by trained medicalprofessionals as a tool to aid inevaluation and informationmanagement of digital medicalimages. Themedical image modalitiesinclude, but are not limited to,CT, MRI, CR, DX, MG | side of the primary predicate. | ||||
| General Information | |||||||
| Property | Proposed DeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| limited to, theevaluation of thepresence orabsence oflesions,determination oftreatment responseand follow-up.RTx supports theloading and savingof DICOM RTobjects and allowsthe user to define,import, display,transform, store andexport such objectsincluding regions ofintereststructures and dosevolumes to radiationtherapy planningsystems. RTxallows the user totransform regions ofinterest associatedwith a particularimaging dataset toanother,supporting atlas-based contouringand rapid re-contouring of thesame patient. | US, SPECT, PET and XA assupported by ACR/NEMADICOM 3.0. MIM 4.1(SEASTAR) assists in thefollowing indications:* Receive, transmit, store,retrieve, display, print, andprocess medical imagesand DICOM objects.* Create, display and printreports from medical images.* Registration, fusion display,and review of medical imagesfor diagnosis,treatment evaluation, andtreatment planning.* Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolic volume,end-systolic volume, andejection fraction.* Localization and definition ofobjects such as tumors andnormal tissues inmedical images.* Creation, transformation, andmodification of contours forapplicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy,transferring contours to radiationtherapy treatment planningsystems, andarchiving contours for patientfollow-up and management.* Quantitative and statisticalanalysis of PET/SPECT brain | ||||||
| Property | Proposed DeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| registered PET/SPECT brainscansLossy compressed mammographic images anddigitized film screen images must not be reviewed forprimary image interpretations. Images that are printed to filmmust be printed using a FDA-approved printer for thediagnosis of digital mammography images.Mammographic images must be viewed on a displaysystem that has been cleared by the FDA for the diagnosis ofdigital mammography images. The software is not to be used | |||||||
| General Information | |||||||
| System Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM 4.1 (SEASTAR) | Comment | |
| Method of Use | Standalonesoftwareapplicationaccessed via acompliantbrowser (Chromeor MozillaFirefox) on apersonalcomputer, tabletor phone (Incase ofconnection to theplatform with ascreen of aphone or atablet, the usermust choose theoption for thedesktop site ofhiscommunicationdevice. Theplatform isoptimally usedwith 17 inchesand up screen.Facilitatesdisplay andvisualization ofdata by user. | Standalonesoftware | Standalone softwareapplication | Standalone softwareapplication | Standalone software package | The proposed device andpredicates have identicalmethods of use | |
| ComputerPlatform andOperatingSystem | Full web platformLaunch fromGoogle Chromeor Mozilla Firefox | Windows | Workstation andServer basedapplicationsupporting WindowsServer 2008 R2 | Server basedapplicationsupporting MicrosoftWindows 10 (64-bit)and Microsoft | Windows 2000/XP | The proposed devices andpredicates are compatible withidentical operating systems | |
| System Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM 4.1 (SEASTAR) | Comment | |
| SP1 and Windows 7(64-bit) | Windows Server2016. | ||||||
| DataVisualization /GraphicalInterface | Yes | Yes | Yes | None - theproposed devicehas no datavisualizationfunctionality. All dataprocessing isautomated and doesnot require userinteraction. A controlinterface is providedfor systemadministration andconfiguration only. | Yes | The proposed device is identicalto the primary predicate, andsecondary predicate, MIM 4.1, inthat it has a graphical interface.Workflow Box is Al based buthas no interface. RTx is not Albased but has an interface andthus most of the tools ofAnnotate for contouredition/display | |
| SupportedModalities | Registration:Static and gatedCT, MR, PET(via theregistration ofthe CT of saidPET)Segmentation:CT (injected ornot), DICOMRTSTRUCT | Registration:MultimodalityDICOM fixed andmoving imagesincluding CT,MR, PETSegmentation:Non-contrast CT | Static and gated CTand PET, MR,SPECT, NM,DICOM RT | CT, MR, DICOMRTSTRUCT forimageprocessingAny valid DICOMdata for data routing | Medical image modalities include,but are not limited to, CT, MRI,CR, DX, MG, US, SPECT, PETand XA as supported byACR/NEMA DICOM 3.0. | The proposed device iscompatible with the samemodalities as the primarypredicate on the registrationfeature, which are CT, MR andPET images in a DICOM format.For both devices, supportedimages can be fixed (static) ormoving (gated).The primary predicate deviceand ART-Plan are bothcompatible only with CT imageson the segmentation feature.The predicate device claims tohandle only non-injected CTswhile ART-Plan can be usedwith injected CT images as well. | |
| System Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM 4.1 (SEASTAR) | Comment | |
| explicitly mention the formatRTStruct in supportedmodalities which correspond tothe format used to storesegmentation masks inradiotherapy. The terms"medical images and DICOMdata" are used by the primarypredicate device, which canimply the management ofDICOM RTStruct.Compared to secondarypredicates, ART-Plan claimsless supported modalities. | |||||||
| Data Export | Distribution ofDICOMcompliantImages intoother DICOMcompliantsystems. | Allows export ofmedical imagesand DICOM data | Distribution ofDICOM compliantImages into otherDICOM compliantsystems. | Supports routingand distribution ofimages to otherDICOM nodesincluding to customexecutablesdetermined by theuser. | The system has the ability to senddata to DICOM-ready devices forimage storage, retrieval andtransmission. | The proposed device andprimary predicates haveidentical data exportcapabilities. | |
| Comtibility | Compatible withdata from anyDICOMcompliantscanners for theapplicablemodalities. | No Limitation onscanner model,DICOM 3.0compliancerequired.Compatible withMicrosoftWindows. | Compatible withdata from anyDICOM compliantscanners for theapplicablemodalities. | Compatible withdata from anyDICOM compliantscanners for theapplicablemodalities.Integration withMirada DBxapplication launcher | The software can receive,transmit, store, retrieve, display,print, and process DICOM objectsand medical image modalitiesincluding, but not limited to, CT.MRI, CR, DX, MG, US, SPECT,PET and XA as supported byACR/NEMA DICOM 3.0. | The proposed device andprimary predicates haveidentical compatibilities | |
| System Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM 4.1 (SEASTAR) | Comment | |
| No Limitation ontreatmentplanning system(TPS) model,DICOM 3.0compliancerequired. | and data browser | ||||||
| Technical Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| DelineationMethod | Al | Al | Atlas | Al | Atlas | The proposed device, primarypredicate and secondarypredicate Workflow Box sharean Al delineation method. | |
| Imageregistration | Multi-modaland mono-modal.Rigid anddeformableAutomatic andmanualinitialization(landmarks,fusion box,alignment).Registration forthe purposes ofreplanning/recontouringand Al-basedautomaticcontouring. | Automaticregistration.Multi-modal andmono-modal.Deformableregistration.Intensity basedalgorithmRegistration forthe purpose oftreatmentplanning,treatmentevaluation andtreatmentadaptation. | Manual and LandmarkRigid. Automatic multi-modal rigid. Mono-modal and multi-modaldeformable registration.Motion correction inhybrid scans and gatedscans.Registration for thepurposes ofreplanning/recontouringand atlas-basedcontouring. | Registration for thepurposes ofreplanning/re-contouring andAl basedcontouring. Thealgorithms usedfor imageregistration are thesame for both RTxand Workflow Boxdevices. | Registration, fusion display, andreview of medical images fordiagnosis, treatmentevaluation, and treatmentplanning. | Both the predicate device andART-Plan offer mono-modal (CT-CT) and multi-modal (CT/MR,CT/PET) deformable registration.The SmartFuse module of ART-Plan also offers rigidregistration, which is areduction of the deformableregistration since the degree offreedom of the transformationare constrained.Both devices offer an automaticsolution for registration. ART-Plan also offers semi-automaticregistration by including manualinitialization tools in addition toautomatic initialization.Secondary devices offer thesame options as the proposeddevice: rigid and deformabletransformation. No informationis given on the possibleautomatization of this process. | |
| SegmentationFeatures | AutomaticallydelineatesOARs andhealthy lymphnodes (on any | Automaticallydelineates OAR(on non-contrastCT images) | Automaticallydelineates any structure(OAR or lymph node)included in the atlas | Not stated. | The software automaticallygenerates contours using adeformable registration techniquewhich registers pre-contouredpatients to target patients. | The proposed device andprimary predicate are capable ofautomatically contouring theorgan-at-risk (OAR). | |
| Technical Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| CT images)Deep learningalgorithm.Automaticsegmentationincludes thefollowinglocalizations:* head andneck* thorax/breast(formale/female)* abdomen* pelvis (formale only)* brain. | Deep learningalgorithm.It canautomaticallycontour theorgan-at-risk,including headand neck,thorax, abdomenand pelvis (forboth male andfemale), | images.Atlas algorithm (contourregistration)Automaticsegmentation supportsany anatomy includedin atlas images. | Registrations are eitherbetween a serial pair of intra-patient volumes or between a pre-existing atlas of contoured patientsand a patient volume. This processfacilitates contour creation or re-contouring for adaptive therapy. | They differ in that ART-Plan canalso delineate healthy lymphnodes.Plus, there is a difference inintended anatomies. Thecommon localizations are thehead and neck, thorax, abdomenand male pelvis. ART-Plan doesnot claim to offer automaticsegmentation on female pelvis.However, in addition to the 4upper common localizations,ART-Plan can also be used forbrain localizations.Secondary predicate usingatlas-based algorithms can beapplied on any localization andfor any type of structurecontained in atlas images usedby the center. | |||
| ViewManipulationandVolumeRendering | Window andlevel, pan,zoom, cross-hairs, slicenavigation.Maximum,average andminimumintensityprojection (MIP,AVG, MinIP),color rendering,multi-planarreconstruction(MPR), fusedviews,gallery views. | Not stated | Window and level, pan,zoom, cross-hairs, slicenavigation.Maximum or minimumintensity projection(MIP),volume rendering, colorrendering, surfacerendering,multi-planarreconstruction (MPR),fused views,gallery views. | None - Notapplicable | Not stated | No information has been foundregarding view manipulation andvolume rendering concerningthe primary predicate. Thepredicate device claims to offera feature to review theprocessed image and performmanual contouring, whichimplies at least the display ofDICOM images with slicenavigation.The proposed device has themajority of the same tools as thesecondary RTx predicate, apartfrom volume and surface | |
| Technical Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| renderingThe Workflow Box secondarypredicate does not offer agraphical interface. | |||||||
| Regions andVolumesof Interest(ROI) | Al Basedautocontouring,Registrationbased contourprojection (re-contouring),Manual ROImanipulationandtransformation(margins,booleansoperators,interpolation). | Automatic targetvolumedelineationsystem.Automaticallydelineatesorgans-at-risk(OAR)Manual Contour | 2D and 3D ROIs, semi-automatic ROIdefinition, isocontourROIs using thresholdand percentage ofmaximum, one-clickseed-pointingcontouring, manual ROImanipulation, ROItransformation, Atlas-based contouring. | Atlas Basedcontouring,registration basedrecontouring,machine learningbased contouring | Atlas based contouring, tools toquickly create, transform, andmodify contours. | Both the proposed device andthe primary predicate allow Alautomatic contouring andmanual contouring | |
| Region/volumeofinterestmeasurementsandsizemeasurements | Intensity,Hounsfieldunits and SUVmeasurementsSizemeasurementsinclude 2D and3Dmeasurements(number ofslices, volumeof a structure,static ruler) | Not stated | Intensity, Hounsfieldunits, activity and SUVmeasurementsincluding min, max,mean, peak, standarddeviation, totalglycolytic activity,median, histogram, maxand mean ratio toreference region.Gray for RT Dose.Size measurementsinclude 2D and 3Dmeasurementsincluding rulers andvolume, line profile. | None - notapplicable | Quantitative analysis tools. | ART-Plan offers the sameIntensity, Hounsfield units andSUVmeasurements and sizemeasurements including 2D and3D measurements (volume andruler) as secondary predicateRTx. However, this is only afraction of the tools claimed bysecondary predicate RTx. | |
| Technical Information | |||||||
| Property | ProposedDeviceART-Plan | PrimaryPredicateAccuContour | SecondaryPredicateRTx | SecondaryPredicateWorkflow Box | Secondary PredicateMIM4.1 (SEASTAR) | Comment | |
| Region/VolumeQuantification | None | Not stated | Regions table withcharting supportsanalysis ofmeasurement overmultiple studies usingstandard protocols suchas RECIST, PERCISTand WHO | None - notapplicable | Quantitative analysis tools. | The secondary predicate RTxoffers a range of tools forregion/volume quantification.ART-Plan does not offer thesekinds of tools. It is a reduction inclaim or equivalent to theprimary predicate for which noinformation was found. |
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System Information Comparison
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Technical Information Comparison
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Device Description:
The ART-Plan application is comprised of two kev modules: SmartFuse and Annotate, allowing the user to display and visualize 3D multi-modal medical image data. The user may process, render, review, store, display and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated CT (computerized tomography), PET (positron emission tomography), and MR (magnetic resonance).
The overview of the product, in terms of input/output, functionalities and integration within the current clinical workflow for radiation therapy planning.
The ART-Plan technical functionalities claimed by TheraPanacea are the following:
- . Proposing automatic solutions to the user, such as an automatic delineation, automatic multimodal image fusion, etc. towards improving standardization of processes/ performance / reducing user tedious / time consuminq involvement.
- . Offering to the user a set of tools to assist semi-automatic delineation, semi-automatic registration towards modifying/editing manually automatically generated structures and addinq/removing new/undesired structures or imposing user-provided correspondences constraints on the fusion of multimodal images.
- . Presenting to the user a set of visualization methods of the delineated structures, and registration fusion maps.
- . Saving the delineated structures / fusion results for use in the dosimetry process.
- . Enabling rigid and deformable registration of patients images sets to combine information contained in different or same modalities.
Technological Characteristics:
A comparative review of the ART-Plan with the predicate device found that the technology. mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device.
Non-Clinical Tests (Performance/Physical Data):
The ART-Plan was evaluated for its safety and effectiveness based on the following testing:
| Test Name | Test Description | Results |
|---|---|---|
| Usability Testing | The ART-Plan was assessed withregards to usability for compliancewith IEC 62366 | Passed |
| Autosegmentationperformances | The study gathers the information onthe 3 tests performed on theautomatic segmentation performanceson European data. | Passed |
| Test Name | Test Description | Results |
| Autosegmentationperformances according toAAPM requirements | The testing demonstrated that theauto-segmentation algorithm of themodule Annotate provides acceptablecontours for the concerned structureson an image of a patient. | Passed |
| Autosegmentationperformances against MIM | The testing demonstrated that theauto-segmentation algorithm of themodule Annotate provides acceptablecontours for the concerned structureson an image of a patient. | Passed |
| Qualitative validation ofautoseqmentationperformances | The testing demonstrated that theauto-segmentation algorithm of themodule Annotate provides acceptablecontours for the concerned structureson an image of a patient. | Passed |
| External Contourperformances according toAAPM requirements | The testing demonstrated that theExternal Contour AutomaticSegmentation algorithm of the moduleAnnotate provides acceptablecontours for the patient's body on animage of a patient. | Passed |
| Fusion performancesaccording to AAPMrecommendations | The testing evaluated the quality ofthe rigid and deformable registrationtools of the SmartFuse module onretrospective intra-patient images andinter-patient images of differentmodalities, to ensure the safety of thedevice for clinical use. | Passed |
| Registration performanceson POPI-model | The testing evaluated the quality ofthe deformable registration tools of theSmartFuse module on intra-patient CTimages.Testing was conducted according toPOPI-model protocol oncorresponding public data. | Passed |
| Test Name | Test Description | Results |
| Autosegmentationperformances on US data | The testing demonstrated that theautosegmentation algorithm of theAnnotate module provides clinicallyacceptable contours for the concernedstructures when applied to USpatients. | Passed |
| Pilot study for sample sizeestimation - literaturereview | The testing was a pilot studyestimating a consistent sample size ofdataset for our performance testing'sconsidering the state-of-art studies inimage registration and segmentation.The literature review was completedon the most cited articles in the field ofmedical vision. | Passed |
| System Verification andValidation Testing | The system verification and validationtesting was performed to verify thesoftware of the ART-Plan. | Passed |
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Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software for this device was considered as a "major" level of concern, since a failure or latent design flaw could directly result in death or serious injury to the patient or a failure or provide diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death.
Animal Studies
No animal studies were conducted as part of submission to prove substantial equivalence.
Clinical Studies
No clinical studies were conducted as part of submission to prove substantial equivalence.
Safety and Effectiveness/Conclusion:
Based on the information presented in these 510(k) premarket notifications the TheraPanacea ART-Plan is considered substantially equivalent.
Based on testing and comparison with the predicate devices, TheraPanacea ART-Plan indicated no adverse indications or results. It is our determination that the TheraPanacea ART-
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Plan is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.
§ 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).