Who is the manufacturer of Contour ProtégéAI?

Mim Software, Inc. filed the 510(k) submission for Contour ProtégéAI (K231765).

What is the FDA product code for Contour ProtégéAI?

QKB. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Contour ProtégéAI?

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

Does Contour ProtégéAI use AI or machine learning?

Yes. Contour ProtégéAI (K231765) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

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

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

Can an AI/ML device like Contour ProtégéAI get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Contour ProtégéAI

K231765 · Mim Software, Inc. · QKB · Nov 8, 2023 · Radiology

Device Facts

Record ID	K231765
Device Name	Contour ProtégéAI
Applicant	Mim Software, Inc.
Product Code	QKB · Radiology
Decision Date	Nov 8, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Contour ProtégéAI is an accessory to MIM software. It includes processing components to automatically contour imaging data using machine-learning based algorithms. Contour ProtégéAI must be used in conjunction with MIM software to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAI is not intended to automatically detect lesions.

Device Story

Contour ProtégéAI is a software accessory to MIM software that automates anatomical contouring on CT and MR images. It utilizes machine-learning neural network models (version 4.1.0) to segment structures for radiation therapy planning and management. The device operates on Windows, Mac, or Linux systems, either locally or via the MIMcloud service. Clinicians input medical images; the device processes these to generate automated contours. The healthcare provider reviews and edits these outputs using MIM software visualization tools. This automation aims to reduce manual contouring time and improve workflow efficiency in radiation oncology. The device is not intended for lesion detection.

Clinical Evidence

Bench testing only. Performance evaluated on 754 independent images from 27 institutions. Metrics included Dice coefficient, MDA, and cumulative APL. Results showed non-inferiority to the reference predicate (MIM Maestro) across all models. User beta testing on a three-point scale confirmed clinical utility. No clinical prospective/retrospective patient outcome data provided.

Technological Characteristics

Software-based medical image processing system. Utilizes machine-learning neural network models (v4.1.0). Operates on Windows, Mac, and Linux platforms. Supports cloud-based (MIMcloud) or local deployment. Compliant with ACR/NEMA DICOM 3.0 standards for CT and MR modalities. No physical materials or energy sources.

Indications for Use

Indicated for trained medical professionals to assist in automated processing of digital medical images (CT and MR, DICOM 3.0 compliant). Supports creation of contours via machine-learning for quantitative analysis, adaptive therapy, transfer to radiation therapy planning systems, and archiving. Supports segmentation of anatomical structures in CT and segmentation of prostate, seminal vesicles, and urethra in T2-weighted MR images.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Contour ProtégéAI (K223774)

Reference Devices

MIM 4.1 SEASTAR (MIM Maestro) (K071964)

Related Devices

K250035 — Contour ProtégéAI+ · Mim Software, Inc. · Feb 3, 2025
K210632 — Contour ProtegeAI · Mim Software, Inc. · Oct 20, 2021
K213976 — Contour ProtégéAI · Mim Software, Inc. · Feb 3, 2022
K193252 — Contour ProtegeAI · Mim Software, Inc. · Jul 2, 2020
K223774 — Contour ProtégéAI · Mim Software, Inc. · Apr 6, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ November 8, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION". MIM Software Inc. % Lynn Hanigan Principal Regulatory and Quality Specialist 25800 Science Park Drive, Suite 180 CLEVELAND. OH 44122 Re: K231765 Trade/Device Name: Contour ProtégéAI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QKB Dated: October 9, 2023 Received: October 10, 2023 Dear Lynn 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming {1}------------------------------------------------ product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Loca Weidner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231765 Device Name Contour ProtégéAI ### Indications for Use (Describe) Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications: · 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 anatomical structures across a variety of CT anatomic locations. · And segmenting the prostate, the seminal vesicles, and the urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results 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) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K231765 Image /page/3/Picture/1 description: The image shows the logo for MIM Software. The logo consists of a red square with rounded corners, partially covered by a gray square with rounded corners and a white circle in the middle. 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. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com # 510(k) Summary of Safety and Effectiveness (The following information is in conformance with 21 CFR 807.92) ### Submitter: MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 216-455-0600 Phone: 216-455-0601 Fax: Contact Person: Lynn Hanigan October 5, 2023 Date Summary Prepared: ### Device Name Trade Name: Common Name: Regulation Number / Product Code: Classification Name: Contour ProtégéAl Medical Imaqing Software 21 CFR 892.2050 Product Code QKB Radiological Image Processing Software For Radiation Therapy # Predicate Devices | Primary - | K223774 | Contour ProtégéAI | MIM Software Inc. | |-------------|---------|-----------------------------------------|-------------------| | Reference - | K071964 | MIM 4.1 SEASTAR (tradename MIM Maestro) | MIMvista Corp. | ### Intended Use Contour ProtégéAI is an accessory to MIM software. It includes processing components to automatically contour imaging data using machine-learning based algorithms. Contour ProtégéAl must be used in conjunction with MIM software to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAl is not intended to automatically detect lesions. #### Indications for Use Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications: - Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation {4}------------------------------------------------ Image /page/4/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 where they overlap. To the right of the squares is the text "mim" in a sans-serif font, with the word "SOFTWARE" in a smaller font below it. The logo is simple and modern, with a focus on the company's name. therapy treatment planning systems, and archiving contours for patient follow-up and management. - Segmenting anatomical structures across a variety of CT anatomical locations. - And segmenting the prostate, the seminal vesicles, and the urethra within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAl. # Device Description Contour ProtégéAI 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; or locally on the workstation or server running MIM software. A total of 550 CT images from 41 clinical sites across multiple continents was gathered for the training of the final 4.1.0 neural network models. The following table lists the data used for the training of the 4.1.0 final production models. Across the training data, 56.4% were male, 25.8% were female, and 17.8% were not labeled. Training data patient age ranges were 1-20: 0.2%, 20-40: 1.8%, 40-60: 8.9%, 60+: 24.2%, and not labeled 64.9%. Images were acquired by scanners made by: Phillips, 38.5%, GE, 17.6%; Siemens, 16.2%; Toshiba, 2.7% and not labeled 25.0%. Over the dataset, 38.7% of the images were acquired with IV or oral contrast, and 61.3% were acquired with no contrast. | Institution | Country | # of images | |----------------|-----------|-------------| | Institution 1 | USA | 2 | | Institution 2 | USA | 5 | | Institution 3 | USA | 26 | | Institution 4 | USA | 8 | | Institution 5 | USA | 3 | | Institution 6 | USA | 1 | | Institution 7 | USA | 34 | | Institution 8 | USA | 17 | | Institution 9 | USA | 6 | | Institution 10 | Hong Kong | 30 | | Institution 11 | USA | 13 | | Institution 12 | USA | 6 | | Institution 13 | USA | 10 | | Institution 14 | USA | 6 | | Institution 15 | USA | 24 | | Institution 16 | USA | 2 | | Institution 17 | USA | 14 | Table 1: CT data used to train the final production of the 4.1.0 CT models. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the MIM Software logo. 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, with a focus on geometric shapes and clean lines. | Institution | Country | # of images | |----------------|-----------|-------------| | Institution 18 | USA | 7 | | Institution 19 | USA | 27 | | Institution 20 | USA | 27 | | Institution 21 | USA | 6 | | Institution 22 | USA | 41 | | Institution 23 | Australia | 19 | | Institution 24 | USA | 10 | | Institution 25 | USA | 11 | | Institution 26 | USA | 10 | | Institution 27 | USA | 2 | | Institution 28 | USA | 1 | | Institution 29 | USA | 6 | | Institution 30 | USA | 9 | | Institution 31 | USA | 4 | | Institution 32 | USA | 2 | | Institution 33 | USA | 6 | | Institution 34 | USA | 2 | | Institution 35 | USA | 6 | | Institution 36 | USA | 14 | | Institution 37 | USA | 4 | | Institution 38 | USA | 5 | | Institution 39 | USA | 75 | | Institution 40 | Australia | 48 | | Institution 41 | USA | 1 | # Substantial Equivalence | ITEM | Subject Device: Contour ProtégéAl (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | |--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Clearance Dates | TBD | 04/06/2023 | 9/26/2007 | | ITEM | Subject Device: Contour ProtégéAl (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | Intended Use | Contour ProtégéAI is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine- learning-based algorithms automatically. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAl is not intended to detect or contour lesions. | Contour ProtégéAI is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. Contour ProtégéAl is not intended to detect or contour lesions. | MIM 4.1 (SEASTAR) software is intended for trained medical professionals including, but not limited to, radiologists, oncologists. physicians, medical technologists, dosimetrists, and physicists. MIM 4.1 (SEASTAR) is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, as well as create, display and print reports from those images. The medical modalities of these medical imaging systems include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) provides tools to quickly create, transform, and modify contours for | | ITEM | Subject Device: Contour ProtégéAl (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | Indications for Use | Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications: | Trained medical professionals use Contour ProtégéAl as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAl supports the following indications: | MIM 4.1 (SEASTAR) software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical | | | 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. | 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. | images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. MIM 4.1 (SEASTAR) assists in the following | | | Segmenting anatomical structures across a variety of CT anatomical locations. And segmenting the prostate, the seminal vesicles, and the urethra | Segmenting anatomical structures across a variety of CT anatomical locations. And segmenting the prostate, the seminal vesicles, and the urethra | indications: Receive, transmit, store, retrieve, display, print, and process medical images | | ITEM | Subject Device: Contour ProtégéAl (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | | within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. | within T2-weighted MR images. Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI. | and DICOM objects. · Create, display and print reports from medical images. · Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. • Localization and definition of objects such as tumors and normal tissues in medical images. · Creation, transformation, and modification of contours 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. | | ITEM | Subject Device: Contour ProtégéAl (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | Modalities | CT and MR | CT and MR | CT, MR, CR, DX, MG, US, SPECT, PET and XA | | Atlas-Based Segmentation | No | No | Yes | | Automatically Contour Imaging Data Using Machine-Learning | Yes | Yes | No | | Operating Platform | Server-based application supporting Linux-based OS - and - Local deployment on Windows or Mac | Server-based application supporting Linux-based OS - and - Local deployment on Windows or Mac | Windows, Mac | | Cloud-based deployment | Yes | Yes | No | | Locally deployed (or installed) | Yes | Yes | No | | ITEM | Subject Device: Contour Protégé Al (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | Neural Network Models included | (1.0.0 models) Head and Neck CT Prostate CT Thorax CT Liver CT Prostate MR (1.1.0 model) Prostate MR (2.0.0 models) Head and Neck CT Prostate CT Thorax CT Abdomen CT Lungs and Liver CT (3.1.0 models)* Head and Neck CT Prostate CT Thorax CT Abdomen CT Lungs and Liver CT MRT Additional Structures CT (4.0.0 models) Head and Neck CT Thorax CT Abdomen CT Pelvis CT | (1.0.0 models) Head and Neck CT Prostate CT Thorax CT Liver CT Prostate MR (1.1.0 model) Prostate MR (2.0.0 models) Head and Neck CT Prostate CT Thorax CT Abdomen CT Lungs and Liver CT (3.0.0 models) Head and Neck CT Prostate CT Thorax CT Abdomen CT Lungs and Liver CT MRT Additional Structures CT (4.0.0 models) Head and Neck CT Thorax CT Abdomen CT Pelvis CT | None | | ITEM | Subject Device: Contour ProtégéAl (K231765) | Predicate Device: Contour ProtégéAl (K223774) | Reference Predicate: MIM 4.1 SEASTAR [i.e., MIM Maestro] (K071964) | | | SurePlan MRT CT | SurePlan MRT CT | | | | (4.1.0 models) | | | | | Head and Neck CT | | | | | Thorax CT | | | | | Whole Body - Physiological Uptake Organs CT | | | {6}------------------------------------------------ Image /page/6/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 cut out of the red square. To the right of the squares is the text "mim" in a 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the MIM Software logo. The logo consists of a red square with a white circle cut out of the top left corner, and a gray square overlapping the top left corner of the red square. To the right of the squares is the word "mim" in black, with the word "SOFTWARE" in smaller black letters below it. {8}------------------------------------------------ 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. {9}------------------------------------------------ Image /page/9/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 where they overlap. To the right of the squares is the text "mim" in a stylized font, with the word "SOFTWARE" in smaller letters below it. {10}------------------------------------------------ Image /page/10/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" in a bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. {11}------------------------------------------------ Image /page/11/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 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. # Discussion Changes within this submission include new 4.1.0 neural network models with additional contours. These changes differ when comparing to Contour ProtégéAl 510(K)223774. Noninferiority testing was used to compare the proposed Contour ProtégéAl device to Atlases created from the MIM Maestro (K071964) reference device. # Testing and Performance Data The proposed Contour ProtégéAl device were then evaluated on the test subjects from a pool of 754 independent images gathered from 27 institutions. The CT images for this training set were obtained from clinical treatment plans for patients prescribed external beam or molecular radiotherapy, but the original segmentations were not used. Instead, the images were re-segmented by consultants (physicians and dosimetrists) specifically for this purpose, outside of clinical practice. Detailed instructions derived from relevant published clinical contouring quidelines were prepared for the dosimetrists. The initial segmentations were then reviewed and corrected by a radiation oncologist against the same standards and quidelines. Qualified staff at MIM Software (M.D. or licensed dosimetrists) then performed a final review and correction. All segmenters were instructed to spend additional time to ensure the highest quality training data. In particular, the consultants were asked to contour all specified OAR structures on all images according to referenced standards, whether or not they were proximal to the treatment field. All patients were imaged on an indexed couch in treatment position ("simulation CT"). Series that were non-axial, had slices thinner than 0.5mm, or had non-Fan Beam or MV acquisitions were excluded. The verification data used for testing is from a set of institutions that are totally disioint from the training datasets used to train each model in the Contour ProtégéAl device. The reference predicate MIM device was configured with Atlases built from the same training data used to train {12}------------------------------------------------ Image /page/12/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 where they intersect. 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 models. We tested Contour ProtégéAl against the reference predicate device, and the goal of this testing is to show that it is equivalent or superior to the reference predicate. The performance of both segmentation devices was measured by calculating both the Dice score and MDA of the novel segmentations with the original ground-truth contours. User beta testing was also used to evaluate the performance of Contour ProtégéAl in the context of time savings compared to contouring from scratch. This user evaluation was made on a three-point scale for each contour, with one indicating negligible time savings, two indicating moderate, and three indicating significant time savings. Our acceptance criteria combine the statistical tests and the user evaluation - only structures that pass two or more of the following three tests could be included in the final models: - Statistical non-inferiority of the Dice score compared with the reference predicate. ● - . Statistical non-inferiority of the MDA score compared with the reference predicate. - Average user evaluation of 2 or higher, when measured on a three-point scale. . Further clinical validation was also conducted in-house to evaluate contours compared to detailed criteria based on established clinical quidelines. In addition, each model as a whole was also evaluated. In order to be included in the released product, the cumulative Added Path Length of the contours in the model was evaluated relative to the ground-truth. Cumulative APL has been found to correlate well with the spent in editing and correcting auto-segmented contours (Vaassen et al, 2020)'. Each model was required to have statistically non-inferior cumulative APL compared to the reference predicate. Finally, the localization accuracy of each structure in all models was measured. We did not impose a passing criterion on localization accuracy; the results however are included in this summary document and in our User Guide and Whitepaper to allow the user to better understand the performance of the device. Across the testing data the images 48.4% were female, 35.2% were male, and 16.4% were unknown for sex. The manufacturer was GE for 37.9% of images, 25.1% was Siemens, 15.0% were Philips, 0.4% were from Toshiba, and the other 21.6% were unknown. 4.38% were between the ages of 20-40, 21.5% were between 40-60, and 47.9% were over the age of 60. 26.0% were unknown, and 0.3% were under the age 20. The mean and standard deviation Dice coefficients and MDA scores, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAl device and the MIM Maestro atlas seamentation reference device for each structure of each neural network model. Contour ProtégéAl results were equivalent or had better performance than the MIM Maestro atlas segmentation reference device. Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAl segmentation is greater than 0.1 Dice lower than the mean MIM atlas segmentation reference device performance. Results over the validation set compared to the reference device are presented here: | 4.1.0 CT Model: | Structure: | Dice MIM Atlas | Dice Contour ProtégéAl | MDA MIM Atlas | MDA Contour ProtégéAl | External Evaluation Score | |--------------------------------------------------|-------------------|-------------------|------------------------------|------------------|-----------------------------|---------------------------------| | Head and Neck | Bone_Mandible | 0.81 ± 0.07 | 0.86 ± 0.07 (0.83) * | 1.00 ± 0.87 | 0.64 ± 0.31 (0.93) * | 2.86 | | | BrachialPlex_L | 0.17 ± 0.08 | 0.22 ± 0.10 (0.14) * | 3.24 ± 2.62 | 2.82 ± 2.61 (5.12) * | 2.6 | | 4.1.0 CT Model: | Structure: | Dice MIM Atlas | Dice Contour ProtégéAl | MDA MIM Atlas | MDA Contour ProtégéAl | External Evaluation Score | | | BrachialPlex_R | 0.15 ± 0.07 | 0.19 ± 0.09 (0.11) * | 3.62 ± 2.79 | 2.73 ± 2.38 (5.20) * | 2.6 | | | Brain | 0.97 ± 0.01 | 0.98 ± 0.01 (0.97) * | 0.64 ± 0.37 | 0.52 ± 0.36 (0.66) * | 2.71 | | | Brainstem | 0.78 ± 0.09 | 0.82 ± 0.08 (0.78) * | 1.72 ± 0.81 | 1.20 ± 0.65 (1.47) * | 2.71 | | | Cavity_Oral | 0.75 ± 0.14 | 0.76 ± 0.13 (0.68) * | 3.34 ± 2.13 | 3.20 ± 1.93 (4.35) * | 2.71 | | | Cochlea_L | 0.19 ± 0.15 | 0.30 ± 0.18 (0.22) * | 1.26 ± 0.85 | 1.17 ± 0.87 (1.58) * | 2.29 | | | Cochlea_R | 0.17 ±0.15 | 0.32 ± 0.20 (0.23) * | 1.12 ± 0.61 | 1.05 ± 0.68 (1.37) * | 2.29 | | | Eye_L | 0.80 ± 0.08 | 0.87 ± 0.06 (0.83) * | 1.07 ± 0.60 | 0.65 ± 0.51 (0.91) * | 2.57 | | | Eye_R | 0.80 ± 0.10 | 0.86 ± 0.07 (0.82) * | 1.11 ±0.64 | 0.66 ± 0.48 (0.92) * | 2.57 | | | Glnd_Lacrimal_L | 0.22 ± 0.17 | 0.40 ± 0.16 (0.27) * | 0.86 ± 0.54 | 0.68 ± 0.35 (1.05) * | 2.71 | | | Glnd_Lacrimal_R | 0.23 ± 0.16 | 0.45 ± 0.14 (0.34) * | 0.73 ± 0.38 | 0.71 ± 0.52 (1.09) * | 2.71 | | | Glnd_Submand_L | 0.57 ± 0.13 | 0.77 ± 0.11 (0.69) * | 1.74 ± 0.72 | 0.76 ± 0.32 (1.12) * | 3 | | | Glnd_Submand_R | 0.56 ± 0.16 | 0.75 ± 0.11 (0.65) * | 1.82 ± 0.87 | 0.81 ± 0.34 (1.28) * | 3 | | | Glnd_Thyroid | 0.47 ±0.18 | 0.71 ±0.19 (0.57) * | 2.55 ± 2.14 | 1.38 ± 3.18 (3.38) * | 2.71 | | | Lens_L | 0.22 ± 0.23 | 0.61 ± 0.17 (0.52) * | 0.77 ± 0.54 | 0.56 ± 0.47 (0.84) * | 2.29 | | | Lens_R | 0.22 ± 0.22 | 0.63 ± 0.16 (0.54) * | 0.81 ± 0.47 | 0.55 ± 0.33 (0.78) * | 2.29 | | | Lips | 0.38 ± 0.14 | 0.37 ± 0.15 (0.28) * | 4.14 ± 2.86 | 5.26 ± 3.41 (7.27) | 2.83 | | | OpticChiasm | 0.04 ± 0.07 | 0.13 ±0.13 (0.08) * | 2.69 ± 1.87 | 2.46 ± 1.99 (3.55) * | 2 | | | OpticNrv_L | 0.45 ± 0.15 | 0.53 ± 0.14 (0.45) * | 0.97 ± 0.81 | 0.77 ± 0.85 (1.19) * | 2.57 | | | OpticNrv_R | 0.44 ±0.14 | 0.52 ± 0.13 (0.44) * | 1.11 ± 1.24 | 0.80 ± 0.83 (1.34) * | 2.57 | | | Parotid_L | 0.71 ±0.10 | 0.79 ± 0.09 (0.75) * | 2.02 ± 0.95 | 1.30 ± 0.62 (1.68) * | 3 | | | Parotid_R | 0.71 ± 0.09 | 0.80 ± 0.06 (0.76) * | 2.11 ±0.76 | 1.26 ± 0.43 (1.56) * | 3 | | | Pituitary | 0.38 ± 0.18 | 0.54 ± 0.15 | 1.07 ± 0.59 | 0.87 ± 0.54 | 3 | | 4.1.0 CT Model: | Structure: | Dice MIM Atlas | Dice Contour ProtégéAl | MDA MIM Atlas | MDA Contour ProtégéAl | External Evaluation Score | | | | | (0.41) * | | (1.29) * | | | | SpinalCord | 0.66 ± 0.14 | 0.65 ± 0.16 (0.59) * | 0.81 ±0.33 | 0.73 ± 0.41 (0.88) * | 2.86 | | | LN_Neck_IA | 0.48 ± 0.13 | 0.60 ± 0.14 (0.44) * | 1.05 ± 1.51 | 0.47 ± 0.45 (1.81) * | 2.75 | | | LN_Neck_IB_L | 0.70 ±0.05 | 0.79 ± 0.04 (0.73) * | 1.30 ± 0.47 | 0.73 ± 0.24 (1.16) * | 2.75 | | | LN_Neck_IB_R | 0.68 ±0.06 | 0.79 ±0.05 (0.72) * | 1.41 ± 0.51 | 0.73 ± 0.20 (1.19) * | 2.75 | | | LN_Neck_IIA_L | 0.64 ± 0.04 | 0.75 ± 0.05 (0.70) * | 2.02 ± 0.54 | 1.54 ± 0.44 (2.09) * | 2.25 | | | LN_Neck_IIA_R | 0.60 ± 0.08 | 0.76 ± 0.04 (0.69) * | 2.24 ± 0.76 | 1.41 ±0.49 (2.15) * | 2.25 | | | LN_Neck_IIB_L | 0.68 ± 0.11 | 0.80 ± 0.06 (0.68) * | 0.95 ± 0.49 | 0.63 ± 0.31 (1.12) * | 3 | | | LN_Neck_IIB_R | 0.68 ± 0.09 | 0.80 ± 0.06 (0.70) * | 1.19 ± 0.64 | 0.58 ± 0.15 (1.14) * | 3 | | | LN_Neck_III_L | 0.54 ± 0.12 | 0.75 ± 0.07 (0.63) * | 1.53 ± 0.60 | 0.92 ± 0.44 (1.51) * | 3 | | | LN_Neck_III_R | 0.57 ± 0.12 | 0.75 ± 0.07 (0.63) * | 1.57 ± 0.61 | 0.99 ± 0.37 (1.57) * | 3 | | | LN_Neck_IV_L | 0.58 ± 0.08 | 0.69 ± 0.08 (0.59) * | 1.62 ± 0.47 | 1.13 ± 0.37 (1.63) * | 2.75 | | | LN_Neck_IV_R | 0.55 ± 0.11 | 0.71 ± 0.09 (0.58) * | 1.87 ± 0.75 | 1.06 ± 0.33 (1.77) * | 2.75 | | | LN_Neck_V_L | 0.53 ± 0.11 | 0.58 ± 0.09 (0.45) * | 1.43 ± 0.82 | 1.13 ± 0.59 (2.02) * | 3 | | | LN_Neck_V_R | 0.50 ± 0.10 | 0.58 ± 0.11 (0.44) * | 2.03 ± 1.66 | 1.43 ± 0.98 (3.18) * | 3 | | | LN_Neck_VIA | 0.34 ± 0.09 | 0.36 ± 0.11 (0.24) * | 1.20 ± 0.55 | 0.80 ± 0.35 (1.33) * | 2.75 | | | LN_Retropharynx_L | 0.22 ± 0.07 | 0.28 ±0.10 (0.19) * | 1.44 ± 0.87 | 1.54 ± 1.47 (2.93) * | 2.75 | | | LN_Retropharynx_R | 0.21 ± 0.07 | 0.28 ± 0.09 (0.18) * | 1.64 ± 0.93 | 1.49 ± 1.36 (2.82) * | 2.75 | | | LN_Retrostyloid_L | 0.57 ± 0.10 | 0.64 ± 0.09 (0.53) * | 1.58 ± 0.75 | 1.23 ± 0.48 (1.96) * | 2.75 | |…

Contour ProtégéAI

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Contour ProtégéAI

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