Contour ProtégéAI

K213976 · Mim Software, Inc. · QKB · Feb 3, 2022 · Radiology

Device Facts

• Record ID: K213976
• Device Name: Contour ProtégéAI
• Applicant: Mim Software, Inc.
• Product Code: QKB · Radiology
• Decision Date: Feb 3, 2022
• 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 allow the contouring of anatomical structures 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 ProtégéAI is not intended to detect or contour lesions.

Device Story

Contour ProtégéAI is an accessory to MIM software that automates anatomical structure contouring on CT and MR images. It utilizes neural network models to segment structures; outputs are intended for review and editing by clinicians using visualization software. The device operates on Windows, Mac, or Linux workstations, or via MIMcloud for remote data management. It supports radiation therapy workflows, including adaptive therapy and treatment planning. By automating manual contouring, it aims to improve efficiency in quantitative analysis and patient follow-up. It is not intended for lesion detection or contouring.

Clinical Evidence

Bench testing only. Performance evaluated on 739 independent images from 12 institutions. Models trained on 4,061 images from 31 sites. Primary endpoint was Dice coefficient comparison against MIM Maestro atlas-based segmentation. Results demonstrated equivalence (lower 95th percentile confidence bound of Contour ProtégéAI performance > 0.1 Dice lower than mean reference performance) across multiple anatomical structures (e.g., Bladder 0.94, Liver 0.93, Prostate 0.82).

Technological Characteristics

Software-based medical image processing system. Utilizes neural network models for automated segmentation. Operates on Windows, Mac, and Linux platforms. Supports cloud-based (MIMcloud) or local workstation deployment. Compatible with ACR/NEMA DICOM 3.0 standards. No hardware components.

Indications for Use

Indicated for trained medical professionals to assist in automated processing of digital medical images (CT and MR, ACR/NEMA DICOM 3.0 compliant). Supports creation of contours via machine-learning for quantitative analysis, adaptive therapy, transfer to radiation therapy planning systems, and archiving. Segments normal structures in CT anatomical locations and normal structures 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 (K210632)

Reference Devices

• MIM 4.1 SEASTAR (MIM Maestro) (K071964)

Submission Summary (Full Text)

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

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

Re: K213976

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: December 30, 2021 Received: January 5, 2022

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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Julie M. Sullivan, Ph.D. Assistant Director Nuclear Medicine and Radiation Therapy Branch 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) K213976

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, transfering 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.

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) |

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Image /page/3/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 letters "TM" are in superscript to the right of the word "SOFTWARE".

## 510(k) Summary

(The following information is in conformance with 21 CFR 807.92)

#### Submitter:

K213976

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

Phone: [phone] Fax:

Contact Person:

Lynn Hanigan

Date Summary Prepared: Feb 1, 2022

#### Device Name

Trade Name: Common Name: Regulation Number / Product Code: Classification Name:

Contour ProtégéAl Medical Imaging Software 21 CFR 892.2050 / Product Code QKB Medical Image management and processing system

#### Predicate Device

K210632

Contour ProtégéAl

MIM Software Inc.

#### Reference Device

K071964 MIM 4.1 SEASTAR (tradename MIM Maestro) MIMvista Corp.

#### Intended Use

Contour ProtégéAl is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.

Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAl.

Contour ProtégéAl is not intended to detect or contour lesions.

#### Indications for Use

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 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

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Image /page/4/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 SOFTWARE" in black, with "mim" in a larger font than "SOFTWARE".

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 normal structures of the prostate, seminal vesicles, and urethra within T2weighted MR images.

Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAl.

#### 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; or locally on the workstation or server running MIM software.

A total of 4061 CT images from 31 clinical sites across multiple continents was gathered for the training of the final neural network models. The following table lists the data used for the training of the final 3.0.0 production models.

| Institution | Country | # of images |
|----------------|-----------|-------------|
| Institution 1 | USA | 22 |
| Institution 2 | USA | 157 |
| Institution 3 | USA | 105 |
| Institution 4 | Australia | 420 |
| Institution 5 | USA | 67 |
| Institution 6 | USA | 46 |
| Institution 7 | USA | 83 |
| Institution 8 | USA | 82 |
| Institution 9 | USA | 89 |
| Institution 10 | USA | 63 |
| Institution 11 | France | 40 |
| Institution 12 | USA | 116 |
| Institution 13 | Hong Kong | 394 |
| Institution 14 | USA | 73 |
| Institution 15 | USA | 230 |

#### CT data used to train the final production of the 3.0.0 CT models

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Image /page/5/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a gray square with rounded corners overlapping each other. The word "mim" is written in black, bold letters to the right of the squares. Below the word "mim" is the word "SOFTWARE" in smaller, black letters.

| Institution | Country | # of images |
|----------------|---------|-------------|
| Institution 16 | USA | 139 |
| Institution 17 | USA | 15 |
| Institution 18 | USA | 96 |
| Institution 19 | USA | 103 |
| Institution 20 | USA | 29 |
| Institution 21 | USA | 325 |
| Institution 22 | USA | 13 |
| Institution 23 | USA | 54 |
| Institution 24 | USA | 10 |
| Institution 25 | USA | 284 |
| Institution 26 | USA | 622 |
| Institution 27 | USA | 152 |
| Institution 28 | USA | 58 |
| Institution 29 | USA | 66 |
| Institution 30 | USA | 101 |
| Institution 31 | USA | 7 |

## Substantial Equivalence

| ITEM | Contour ProtégéAl<br>(K213976) | Contour ProtégéAl<br>(K210632) | MIM 4.1 SEASTAR<br>[i.e., MIM Maestro]<br>(K071964) |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Dates | TBD | 10/20/2021 | 9/26/2007 |
| Intended Use | Contour ProtégéAl is an<br>accessory to MIM software<br>used for the contouring of<br>anatomical structures in<br>imaging data using machine-<br>learning-based algorithms<br>automatically. | Contour ProtégéAl is an<br>accessory to MIM software<br>used for the contouring of<br>anatomical structures in<br>imaging data using machine-<br>learning-based algorithms<br>automatically. | MIM 4.1 (SEASTAR)<br>software is intended<br>for trained medical<br>professionals<br>including, but not<br>limited to, radiologists,<br>oncologists,<br>physicians, medical |
| ITEM | Contour ProtégéAl<br>(K213976) | Contour ProtégéAl<br>(K210632) | MIM 4.1 SEASTAR<br>[i.e., MIM Maestro]<br>(K071964) |
| | Appropriate image<br>visualization software must be<br>used to review and, if<br>necessary, edit results<br>automatically generated by<br>Contour ProtégéAl.<br>Contour ProtégéAl is not<br>intended to detect or contour<br>lesions. | Appropriate image<br>visualization software must be<br>used to review and, if<br>necessary, edit results<br>automatically generated by<br>Contour ProtégéAl.<br>Contour ProtégéAl is not<br>intended to detect or contour<br>lesions. | technologists,<br>dosimetrists, and<br>physicists.<br>MIM 4.1 (SEASTAR)<br>is a medical image<br>and information<br>management system<br>that is intended to<br>receive, transmit,<br>store, retrieve, display,<br>print and process<br>digital medical<br>images, as well as<br>create, display and<br>print reports from<br>those images. The<br>medical modalities of<br>these medical imaging<br>systems include, but<br>are not limited to, CT,<br>MRI, CR, DX, MG,<br>US, SPECT, PET and<br>XA as supported by<br>ACR/NEMA DICOM<br>3.0.<br>MIM 4.1 (SEASTAR)<br>provides tools to<br>quickly create,<br>transform, and modify<br>contours for<br>applications including,<br>but not limited to,<br>quantitative analysis,<br>aiding adaptive<br>therapy, transferring<br>contours to radiation<br>therapy treatment<br>planning systems and<br>archiving contours for |
| ITEM | Contour ProtégéAl<br>(K213976) | Contour ProtégéAl<br>(K210632) | MIM 4.1 SEASTAR<br>[i.e., MIM Maestro]<br>(K071964) |
| | | | patient follow-up and<br>management. |
| Indications for<br>Use | Trained medical professionals<br>use Contour ProtégéAl as a<br>tool to assist in the automated<br>processing of digital medical<br>images of modalities CT and<br>MR, as supported by<br>ACR/NEMA DICOM 3.0. In<br>addition, Contour ProtégéAl<br>supports the following<br>indications:<br>• Creation of contours using<br>machine-learning<br>algorithms for applications<br>including, but not limited<br>to, quantitative analysis,<br>aiding adaptive therapy,<br>transferring contours to<br>radiation therapy<br>treatment planning<br>systems, and archiving<br>contours for patient follow-<br>up and management.<br>• Segmenting normal<br>structures across a variety<br>of CT anatomical<br>locations.<br>• And segmenting normal<br>structures of the prostate,<br>seminal vesicles, and | Trained medical professionals<br>use Contour ProtégéAl as a<br>tool to assist in the automated<br>processing of digital medical<br>images of modalities CT and<br>MR, as supported by<br>ACR/NEMA DICOM 3.0. In<br>addition, Contour ProtégéAl<br>supports the following<br>indications:<br>• Creation of contours using<br>machine-learning<br>algorithms for applications<br>including, but not limited<br>to, quantitative analysis,<br>aiding adaptive therapy,<br>transferring contours to<br>radiation therapy<br>treatment planning<br>systems, and archiving<br>contours for patient follow-<br>up and management.<br>• Segmenting normal<br>structures across a variety<br>of CT anatomical<br>locations.<br>• And segmenting normal<br>structures of the prostate,<br>seminal vesicles, and | MIM 4.1 (SEASTAR)<br>software is used by<br>trained medical<br>professionals as a tool<br>to aid in evaluation<br>and information<br>management of digital<br>medical images. The<br>medical image<br>modalities include, but<br>are not limited to, CT,<br>MRI, CR, DX, MG,<br>US, SPECT, PET and<br>XA as supported by<br>ACR/NEMA DICOM<br>3.0. MIM 4.1<br>(SEASTAR) assists in<br>the following<br>indications:<br>• Receive, transmit,<br>store, retrieve, display,<br>print, and process<br>medical images and<br>DICOM objects.<br>• Create, display and<br>print reports from<br>medical images.<br>• Registration, fusion<br>display, and review of<br>medical images for |
| ITEM | Contour ProtégéAl<br>(K213976) | Contour ProtégéAl<br>(K210632) | MIM 4.1 SEASTAR<br>[i.e., MIM Maestro]<br>(K071964) |
| | urethra within T2-weighted<br>MR images.<br>Appropriate image<br>visualization software must be<br>used to review and, if<br>necessary, edit results<br>automatically generated by<br>Contour ProtégéAl. | urethra within T2-weighted<br>MR images.<br>Appropriate image<br>visualization software must be<br>used to review and, if<br>necessary, edit results<br>automatically generated by<br>Contour ProtégéAl. | diagnosis, treatment<br>evaluation, and<br>treatment planning.<br>• Localization and<br>definition of objects<br>such as tumors and<br>normal tissues in<br>medical images.<br>• Creation,<br>transformation, and<br>modification of<br>contours for<br>applications including,<br>but not limited to,<br>quantitative analysis,<br>aiding adaptive<br>therapy, transferring<br>contours to radiation<br>therapy treatment<br>planning systems, and<br>archiving contours for<br>patient follow-up and<br>management. |
| Modalities | CT and MR | CT and MR | CT, MR, CR, DX, MG,<br>US, SPECT, PET and<br>XA |
| Atlas-Based<br>Segmentation | No | No | Yes |
| ITEM | Contour ProtégéAl<br>(K213976) | Contour ProtégéAl<br>(K210632) | MIM 4.1 SEASTAR<br>[i.e., MIM Maestro]<br>(K071964) |
| Automatically<br>Contour Imaging<br>Data Using<br>Machine-Learning | Yes | Yes | No |
| Operating<br>Platform | Server-based application<br>supporting<br>Linux-based OS<br>- and -<br>Local deployment on Windows<br>or Mac | Server-based application<br>supporting<br>Linux-based OS<br>- and -<br>Local deployment on Windows<br>or Mac | Windows, Mac |
| Cloud-based<br>deployment | Yes | Yes | No |
| Locally deployed<br>(or installed) | Yes | Yes | No |
| ITEM | Contour ProtégéAl<br>(K213976) | Contour ProtégéAl<br>(K210632) | MIM 4.1 SEASTAR<br>[i.e., MIM Maestro]<br>(K071964) |
| Neural Network<br>Models included | (1.0.0 models)<br>Head and Neck CT<br>Prostate CT<br>Thorax CT<br>Liver CT<br>Prostate MR<br>(1.1.0 model)<br>Prostate MR<br>(2.0.0 models)<br>Head and Neck CT<br>Prostate CT<br>Thorax CT<br>Abdomen CT<br>Lungs and Liver CT<br>(3.0.0 models)<br>Head and Neck CT<br>Prostate CT<br>Thorax CT<br>Abdomen CT<br>Lungs and Liver CT<br>MRT Additional Structures CT<br>(which include:<br>Spleen<br>Pelvic Lymph Nodes<br>Descending Aorta<br>Bone) | (1.0.0 models)<br>Head and Neck CT<br>Prostate CT<br>Thorax CT<br>Liver CT<br>Prostate MR<br>(1.1.0 model)<br>Prostate MR<br>(2.0.0 models)<br>Head and Neck CT<br>Prostate CT<br>Thorax CT<br>Abdomen CT<br>Lungs and Liver CT | None |

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Image /page/6/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 bold, sans-serif font, with the word "SOFTWARE" in a smaller font below it. The letters "TM" are in superscript to the right of the word "SOFTWARE".

25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

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Image /page/7/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.

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Image /page/8/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 in 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. 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 in the intersection. 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.

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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 where they overlap. To the right of the squares is the text "mim" in a bold, sans-serif font, with the word "SOFTWARE" underneath in a smaller font. The letters in "mim" are all lowercase.

25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

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Image /page/11/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 clean and modern, with a simple color palette.

## Discussion

Changes within this submission include new CT 3.0.0 neural network models with additional contours. These changes differ when comparing to Contour ProtégéAl 510(k)210632. Non-inferiority testing was used to compare the proposed Contour ProtégéAl device to Atlases created from the MIM Maestro reference device.

## Testing and Performance Data

For the proposed Contour ProtégéAl device, the new 3.0.0 CT neural network models were trained on a pool of training data that did not include any patients from the same institution as the test subjects. This training data included 4.061 images gathered from 31 clinical sites, from Australia, France, Hong Kong, and the USA. Models were trained using images of adults at various ages. No ethnicities or genders were excluded from training, with the exception of the training pool for the prostate model, for which only subjects with male anatomy were used. The models were then evaluated on the test subjects from a pool of 739 independent images gathered from 12 institutions.

The ground-truth segmentations used for both training and validation were generated by a trained user (typically, a dosimetrist or radiologist) that are then reviewed and approved by a supervising physician (typically, a radiation oncologist or a radiologist) and sent back for re-segmentation and re-review as necessary. The Dice coefficient was then calculated for each structure, and aggregated over all patients. 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.

With the MM Maestro atlas segmentation reference device, multiple Atlases were created over the test subjects. Each Atlas contained images of the same anatomical field of view from the same institution. Each structure appeared in one Atlas. For each patient in an Atlas, the Atlas was used to segment the structures in that patient. The test patient itself was excluded from this Atlas (leave-one-out analysis).

The mean and standard deviation Dice coefficients, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAl device and the MIM Maestro atlas seqmentation reference device for each structure of each neural network model. Contour ProtégéAl results were equivalent or had better performance than the MM 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.

| Structure: | MIM Atlas | Contour ProtégéAl |
|------------------|-------------|----------------------|
| A_Aorta_Desc | 0.73 ± 0.15 | 0.78 ± 0.07 (0.68) * |
| Bladder | 0.80 ± 0.12 | 0.94 ± 0.02 (0.86) * |
| Bone | 0.80 ± 0.03 | 0.83 ± 0.05 (0.76) * |
| Bone_Mandible | 0.79 ± 0.16 | 0.83 ± 0.04 (0.74) * |
| Structure: | MIM Atlas | Contour ProtégéAl |
| Bowel † | 0.60 ± 0.13 | 0.75 ± 0.07 (0.68) * |
| Bowel_Large | 0.15 ± 0.12 | 0.28 ± 0.20 (0.15) * |
| Bowel_Small | 0.29 ± 0.17 | 0.42 ± 0.19 (0.29) * |
| BrachialPlex_L | 0.32 ± 0.11 | 0.37 ± 0.13 (0.27) * |
| BrachialPlex_R | 0.38 ± 0.13 | 0.41 ± 0.10 (0.31) * |
| Brain | 0.97 ± 0.01 | 0.96 ± 0.01 (0.95) * |
| Brainstem | 0.77 ± 0.12 | 0.76 ± 0.12 (0.68) * |
| Breast_L | 0.81 ± 0.06 | 0.81 ± 0.06 (0.76) * |
| Breast_R | 0.83 ± 0.06 | 0.83 ± 0.06 (0.77) * |
| Bronchus | 0.57 ± 0.12 | 0.62 ± 0.11 (0.54) * |
| Carina | 0.54 ± 0.18 | 0.64 ± 0.17 (0.52) * |
| CaudaEquina | 0.74 ± 0.09 | 0.72 ± 0.06 (0.64) * |
| Cavity_Oral | 0.79 ± 0.10 | 0.81 ± 0.11 (0.73) * |
| Cochlea_L | 0.39 ± 0.15 | 0.41 ± 0.17 (0.30) * |
| Cochlea_R | 0.43 ± 0.15 | 0.46 ± 0.17 (0.34) * |
| Colon_Sigmoid | 0.08 ± 0.09 | 0.50 ± 0.19 (0.33) * |
| Esophagus | 0.43 ± 0.17 | 0.56 ± 0.19 (0.47) * |
| Eye_L | 0.83 ± 0.10 | 0.82 ± 0.06 (0.77) * |
| Eye_R | 0.81 ± 0.13 | 0.78 ± 0.06 (0.71) * |
| Femur_Head_L | 0.93 ± 0.04 | 0.90 ± 0.06 (0.86) * |
| Femur_Head_R | 0.93 ± 0.03 | 0.93 ± 0.03 (0.91) * |
| Femur_L | 0.96 ± 0.01 | 0.95 ± 0.01 (0.93) * |
| Femur_R | 0.96 ± 0.02 | 0.94 ± 0.01 (0.91) * |
| Genitals | 0.64 ± 0.11 | 0.68 ± 0.13 (0.53) * |
| GInd_Lacrimal_L | 0.29 ± 0.15 | 0.39 ± 0.20 (0.24) * |
| GInd_Lacrimal_R | 0.31 ± 0.15 | 0.38 ± 0.22 (0.23) * |
| GInd_Submand_L | 0.68 ± 0.10 | 0.78 ± 0.07 (0.71) * |
| Structure: | MIM Atlas | Contour ProtégéAl |
| Glnd_Submand_R | 0.67 ± 0.11 | 0.76 ± 0.06 (0.69) * |
| Glnd_Thyroid | 0.51 ± 0.14 | 0.57 ± 0.18 (0.44) * |
| GreatVes | 0.75 ± 0.06 | 0.71 ± 0.08 (0.65) * |
| Heart | 0.85 ± 0.08 | 0.89 ± 0.04 (0.86) * |
| Humerus_Head_L † | 0.88 ± 0.07 | 0.91 ± 0.04 (0.87) * |
| Humerus_Head_R † | 0.88 ± 0.09 | 0.91 ± 0.03 (0.85) * |
| Kidney_L | 0.76 ± 0.14 | 0.91 ± 0.03 (0.83) * |
| Kidney_R | 0.74 ± 0.18 | 0.89 ± 0.04 (0.80) * |
| Larynx | 0.52 ± 0.15 | 0.57 ± 0.18 (0.44) * |
| Lens_L | 0.30 ± 0.17 | 0.52 ± 0.10 (0.41) * |
| Lens_R | 0.36 ± 0.14 | 0.65 ± 0.09 (0.56) * |
| Lips | 0.39 ± 0.14 | 0.57 ± 0.18 (0.43) * |
| Liver | 0.84 ± 0.12 | 0.93 ± 0.04 (0.87) * |
| LN_Pelvic | 0.76 ± 0.03 | 0.80 ± 0.04 (0.77) * |
| Lung_L | 0.94 ± 0.03 | 0.95 ± 0.02 (0.93) * |
| Lung_R | 0.95 ± 0.02 | 0.95 ± 0.02 (0.94) * |
| Musc_Constrict | 0.44 ± 0.12 | 0.50 ± 0.17 (0.38) * |
| OpticChiasm | 0.34 ± 0.16 | 0.37 ± 0.17 (0.25) * |
| OpticNrv_L | 0.46 ± 0.12 | 0.52 ± 0.10 (0.44) * |
| OpticNrv_R | 0.50 ± 0.10 | 0.54 ± 0.09 (0.47) * |
| Parotid_L | 0.68 ± 0.13 | 0.81 ± 0.04 (0.74) * |
| Parotid_R | 0.71 ± 0.10 | 0.78 ± 0.05 (0.72) * |
| PenileBulb | 0.62 ± 0.12 | 0.65 ± 0.11 (0.56) * |
| Pituitary | 0.53 ± 0.15 | 0.56 ± 0.18 (0.43) * |
| Prostate | 0.71 ± 0.12 | 0.82 ± 0.06 (0.74) * |
| Rectum | 0.67 ± 0.14 | 0.76 ± 0.08 (0.67) * |
| SeminalVes | 0.58 ± 0.15 | 0.70 ± 0.08 (0.60) * |
| Structure: | MIM Atlas | Contour ProtégéAI |
| Spinal_Cord | 0.76 ± 0.10 | 0.82 ± 0.07 (0.78) * |
| Spleen | 0.78 ± 0.14 | 0.91 ± 0.07 (0.80) * |
| Stomach | 0.45 ± 0.20 | 0.79 ± 0.09 (0.69) * |
| Trachea | 0.77 ± 0.09 | 0.73 ± 0.07 (0.67) * |

Results over the validation set compared to the reference device are presented here:

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Image /page/12/Picture/0 description: The image is a logo for MIM Software. The logo consists of a red square with rounded corners and a white circle in the lower left corner, partially covered by a gray square with rounded corners. To the right of the graphic is the text "MIM" in large, bold, black letters, with the word "SOFTWARE" in smaller black letters below.

25800 Science Park Drive - Suite 180 Cleveland, OH 44122 866-421-2536 www.mimsoftware.com

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Image /page/13/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 in the red square. To the right of the squares is the text "MIM" in a bold, sans-serif font, with the word "SOFTWARE" below it in a smaller font. The logo is simple and modern, and the colors are eye-catching.

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Image /page/14/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 large, bold, black letters, with the word "SOFTWARE" in smaller black letters below it. The logo is simple and modern, with a clean design.

Mean ± Std Dice coefficient (lower 95th percentile confidence bound based on normal distribution in parentheses) * Equivalence demonstrated at p=0.05 significance level between Contour ProtégéAI and MIM Atlas † Comparisons for both atlas and Contour ProtégéAI calculated only on axial slices that contained the ground truth.

## Conclusion

Based on the Discussion and Testing and Performance Data above, the proposed device is determined to be as safe and effective as its predicate device, Contour ProtégéAl 510 K210632. In addition, the proposed device performs as well as the reference device, MIM 4.1 SEASTAR K071964.