Contour ProtégéAl is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAl assists in the following indications:

The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.

Segmenting normal structures across a variety of CT anatomical locations.

And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.

Contour ProtégéAI must be used in conjunction with MIM software to review and, if necessary, edit contours that were automatically generated by Contour ProtégAI.

Device Description

Contour ProtégéAl is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl is deployed on a remote server using the MIMcloud service for data management and transfer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for MIM Software Inc.'s Contour ProtégéAI, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Non-inferiority to predicate device	Contour ProtégéAI was shown to be non-inferior to the predicate device (MIM) with regards to the mean Dice coefficient of automatically generated contours. Non-inferiority was established with a limit of 0.1 Dice, meaning the performance of Contour ProtégéAI was no more than 0.1 Dice worse than the predicate.
Clinically acceptable performance	The non-inferiority limit of 0.1 Dice was determined to be the largest clinically acceptable difference based on previous studies.
Automated segmentation of CT images	Demonstrated through the non-inferiority study on a test set of 286 CT images.
Automated segmentation of MR images	Demonstrated through the non-inferiority study on a test set of 72 MR images.

Study Details

Sample sizes used for the test set and data provenance:
- CT Images: 286 images
- MR Images: 72 images
- Data Provenance: The test images were gathered from "a different and disjoint set of institutions from the training data." This indicates an independent, external validation set, likely retrospective in nature given that it's an existing dataset. The specific country of origin is not specified.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The document does not explicitly state the number of experts or their qualifications for establishing the ground truth of the test set. It mentions "associated segmentations" for the training data but not how test set ground truth was created or by whom.
Adjudication method for the test set:
- The document does not specify an adjudication method (e.g., 2+1, 3+1). It states that the neural network models were evaluated against "associated segmentations," implying a reference truth was available.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study evaluating human reader improvement with AI assistance was performed or reported in this summary. The study focused on the standalone performance of the Contour ProtégéAI against a predicate device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The non-inferiority test directly compared the automatically generated contours of Contour ProtégéAI against those of the predicate device, both operating without human intervention for the contouring process itself. The instructions for Contour ProtégéAI do state that it "must be used in conjunction with MIM software to review and, if necessary, edit contours." However, the reported performance study focused on the initial automated segmentation output.
The type of ground truth used:
- The ground truth for both training and testing datasets consisted of "associated segmentations." While not explicitly stated, these are typically expert-generated contours, often from trained medical professionals (e.g., oncologists, radiation oncologists, dosimetrists) or highly experienced image analysts. The document does not specify if pathology or outcomes data were used as ground truth.
The sample size for the training set:
- The document states that the neural networks were "trained on datasets from several large institutions." It does not provide a specific number of images or cases used in the training set.
How the ground truth for the training set was established:
- The training datasets included "CT images and MR images and their associated segmentations." This implies that expert-generated contours were available alongside the images for training the machine-learning models. The specific process or number of experts involved in creating these training segmentations is not detailed in the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MIM Software, Inc. % Ms. Lynn Hanigan Quality Assurance Director 25800 Science Park Drive, Suite 180 CLEVELAND OH 44122

Re: K193252

Trade/Device Name: Contour ProtégéAI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: June 1, 2020 Received: June 3, 2020

Dear Ms. Hanigan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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) K193252

Device Name Contour ProtégéAI

Indications for Use (Describe)

Contour ProtégéAI is used by trained medical professionals as a tool to aid in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. Contour ProtégéAl assists in the following indications:

Segmenting normal structures across a variety of CT anatomical locations.

And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.

Contour ProtégéAI must be used in conjunction with MIM software to review and, if necessary, edit contours that were automatically generated by Contour ProtégéAI.

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/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim SOFTWARE" in black. The word "mim" is in a larger font than the word "SOFTWARE".

510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92)

K193252

Submitter:

MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122

Phone:	216-455-0600
Fax:	216-455-0601
Contact Person:	Lynn Hanigan
Date Summary Prepared:	06/23/2020

Device Name

Trade Name: Contour ProtégéAl Common Name: Medical Imaging Software Requlation Number / Product Code: 21 CFR 892.2050 Product Code QKB Classification Name: System, Imaging Processing, Radiological

Predicate Devices

K190379	MIM on Linux	MIM Software Inc.
K181572	Workflow Box	Mirada Medical Ltd.

Intended Use

Contour ProtégéAl is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically.

Contour ProtégéAl must be used in conjunction with MIM software to review and, if necessary, edit results automatically generated by Contour ProtégéAl.

Contour ProtégéAl is not intended to detect or contour lesions automatically.

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Image /page/4/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle cut out of the red square. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it.

Indications for Use

. The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
Segmenting normal structures across a variety of CT anatomical locations. .
. And segmenting normal structures of the prostate, seminal vesicles, and urethra within T2-weighted MR images.

Contour ProtégéAl must be used in conjunction with MIM software to review and, if necessary, edit contours automatically generated by Contour ProtégéAl.

Device Description

Substantial Equivalence

ITEM	MIM Software Inc.Contour ProtégéAl(K193252)	MIM Software Inc.MIM on Linux(K190379)	Mirada Medical Ltd.Workflow Box(K181572)
Clearance Date	TBD	03-19-2019	07-10-2018
Intended Use	Contour ProtégéAl is anaccessory to MIM softwareused for the contouring ofanatomical structures inimaging data using machine-learning-based algorithmsautomatically.	MIM software is intended fortrained medical professionalsincluding, but not limited to,radiologists, oncologists,physicians, medicaltechnologists, dosimetrists andphysicists.	Workflow Box is a systemdesigned to allow users to routeDICOM-compliant data to andfrom automated processingcomponents.Workflow Box includesprocessing components forautomatically contouringimaging data using deformable
ITEM	MIM Software Inc.	MIM Software Inc.	Mirada Medical Ltd.
	Contour ProtégéAl	MIM on Linux	Workflow Box
	(K193252)	(K190379)	(K181572)
	Contour ProtégéAl must beused in conjunction with MIMsoftware to review and, ifnecessary, edit resultsautomatically generated byContour ProtégéAl.Contour ProtégéAl is notintended to detect or contourlesions automatically.	MIM is a medical image andinformation managementsystem that is intended toreceive, 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 provides the user with themeans to display, register andfuse medical images frommultiple modalities.Additionally, it evaluatescardiac left ventricular functionand perfusion, including leftventricular end-diastolicvolume, end-systolic volume,and ejection fraction.The Region of Interest (ROI)feature reduces the timenecessary for the user to defineobjects in medical imagevolumes by providing an initialdefinition of object contours.The objects include, but are notlimited to, tumors and normaltissues.MIM provides tools to quicklycreate, transform, and modifycontours for applicationsincluding, but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systemsand archiving contours for	image registration and machinelearning based algorithms.Workflow Box must be used inconjunction with appropriatesoftware to review and editresults generated automaticallyby Workflow Box components,for example image visualizationsoftware must be used tofacilitate the review and edit ofcontours generated byWorkflow Box componentapplications.Workflow Box is not intended toautomatically detect lesions.
ITEM	MIM Software Inc.Contour ProtégéAl(K193252)	MIM Software Inc.MIM on Linux(K190379)	Mirada Medical Ltd.Workflow Box(K181572)
		patient follow-up andmanagement.MIM aids in the assessment ofPET/SPECT brain scans. Itprovides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECT brainscans to a standard templateand comparing intensity valuesto a reference database or toother PET/SPECT scans on avoxel by voxel basis, withinstereotactic surface projectionsor standardized regions ofinterest.MIM allows the dosedistribution of an implant to beindividually shaped for eachpatient and is a general-purpose brachytherapyplanning system used forprospective and confirmationdose calculations for patientsundergoing a course ofbrachytherapy using permanentimplants of variousradioisotopes (not includingradioactive microspheres).MIM allows voxel-based dosecalculations for patients whohave been administeredradioisotopes or radioactivemicrospheres.
Indications for Use	Contour ProtégéAl is used bytrained medical professionalsas a tool to aid in the automatedprocessing of digital medicalimages of modalities CT andMR, as supported byACR/NEMA DICOM 3.0.	MIM software is used by trainedmedical professionals as a toolto aid in evaluation andinformation management ofdigital medical images. Themedical image modalitiesinclude, but are not limited to,CT, MRI, CR, DX, MG, US,	Workflow Box is a softwaresystem designed to allow usersto route DICOM-compliant datato and from automatedprocessing components.Supported modalities includeCT, MR, RTSTRUCT.
ITEM	MIM Software Inc.Contour ProtégéAl(K193252)	MIM Software Inc.MIM on Linux(K190379)	Mirada Medical Ltd.Workflow Box(K181572)
	Contour ProtégéAl assists inthe following indications:The creation ofcontours usingmachine-learningalgorithms forapplications including,but not limited to,quantitative analysis,aiding adaptivetherapy, transferringcontours to radiationtherapy treatmentplanning systems, andarchiving contours forpatient follow-up andmanagement. Segmenting normalstructures across avariety of CTanatomical locations. And segmentingnormal structures ofthe prostate, seminalvesicles, and urethrawithin T2-weighted MRimages. Contour ProtégéAl must beused in conjunction with MIMsoftware to review and, ifnecessary, edit contours thatwere automatically generatedby Contour ProtégéAl.	SPECT, PET and XA assupported by ACR/NEMADICOM 3.0. MIM assists in thefollowing indications:Receive, transmit, store,retrieve, display, print, andprocess medical imagesand DICOM objects. Create, display and printreports from medicalimages. Registration, fusiondisplay, and review ofmedical images fordiagnosis, treatmentevaluation, and treatmentplanning. Evaluation of cardiac leftventricular function andperfusion, including leftventricular end-diastolicvolume, end-systolicvolume, and ejectionfraction. Localization and definitionof objects such as tumorsand normal tissues inmedical images. Creation, transformation,and modification ofcontours for applicationsincluding, but not limitedto, quantitative analysis,aiding adaptive therapy,transferring contours toradiation therapytreatment planningsystems, and archivingcontours for patient follow-up and management. Quantitative and statisticalanalysis of PET/SPECTbrain scans by comparingto other registeredPET/SPECT brain scans.	Workflow Box includesprocessing components forautomatically contouringimaging data using deformableimage registration to supportatlas-based contouring, re-contouring of the same patientand machine learning basedcontouring.Workflow Box is a data routingand image processing toolwhich automatically appliescontours to data which is sentto one or more of the includedimage processing workflows.Contours generated byWorkflow Box may be used asan input to clinical workflowsincluding, but not limited to,radiation therapy treatmentplanning.Workflow Box must be used inconjunction with appropriatesoftware to review and editresults generated automaticallyby Workflow Box components,for example image visualizationsoftware must be used tofacilitate the review and edit ofcontours generated byWorkflow Box componentapplications.Workflow Box is intended to beused by trained medicalprofessionals.Workflow Box is not intended toautomatically detect lesions.
ITEM	MIM Software Inc.Contour ProtégéAl(K193252)	MIM Software Inc.MIM on Linux(K190379)	Mirada Medical Ltd.Workflow Box(K181572)
		Planning and evaluation of permanent implantbrachytherapy procedures (not including radioactivemicrospheres). Calculating absorbed radiation dose as a resultof administering a radionuclide. When using device clinically, the user should only use FDAapproved radiopharmaceuticals. If using with unapproved ones, thisdevice should only be used for research purposes.Lossy compressed mammographic images and digitized film screen imagesmust not be reviewed for primary image interpretations. Images that are printed to filmmust be printed using an FDA-approved printer for the diagnosis of digitalmammography images.Mammographic images must be viewed on a display system that has been cleared by theFDA for the diagnosis of digital mammography images. The software is not to be used for
Modalities	CT and MR	CT, MR, CR, DX, MG, US,NM, PET, XA, and otherDICOM modalities	CT and MR
ITEM	MIM Software Inc.Contour ProtégéAl(K193252)	MIM Software Inc.MIM on Linux(K190379)	Mirada Medical Ltd.Workflow Box(K181572)
Atlas-basedContourSegmentation	No	Yes	Yes
AutomaticallyContour ImagingData UsingMachine-Learning	Yes	No	Yes
Operating Platform	Server-based applicationsupportingLinux-based OS	Microsoft® Windows,Apple® OS,Linux-based OS	Server based applicationsupportingMicrosoft Windows 10 (64-bit)andMicrosoft Windows Server2016

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Image /page/5/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette.

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Image /page/6/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.

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Image /page/7/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.

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Image /page/8/Picture/0 description: The image is a logo for MIM Software. The logo consists of two overlapping rounded squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.

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Image /page/9/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is clean and modern, with a simple color palette.

Contour ProtégéAl is substantially equivalent to a combination of the predicate devices MIM on Linux (K190379) and Mirada Workflow Box (K181572).

Testing and Performance Data

The neural networks used in the Contour ProtégéAl device were trained on datasets from several large institutions. These datasets included CT images and MR images and their associated segmentations.

For testing, 286 images were used to evaluate the neural network models that segmented CT images, while 72 images were used to evaluate for the MR segmentation network. In all cases, the test images were gathered from a different and disjoint set of institutions from the training data. Both Contour ProtégéAI and the MIM predicate device were used to automatically segmented the independent test sets to show substantial equivalence.

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Image /page/10/Picture/0 description: The image shows the logo for MIM Software. The logo consists of two overlapping squares, one gray and one red, with a white circle where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.

To establish the performance of Contour ProtégéAl, a non-inferiority test was performed. This non-inferiority test compared the mean Dice coefficient of the automatically generated contours for Contour ProtégéAI against that of the predicate device. For all neural network models, evidence was established that the Contour ProtégéAl device was non-inferior to the predicate by at least a non-inferiority limit of 0.1 Dice, which was as the largest difference that is clinically acceptable based on previous studies, and thus we conclude that equivalence has been demonstrated.

Regulation Number and Section

§ 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).