Who is the manufacturer of Constellation (CON-001)?

Q Bio, Inc. filed the 510(k) submission for Constellation (CON-001) (K241280).

What is the FDA product code for Constellation (CON-001)?

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

What is the regulatory pathway for Constellation (CON-001)?

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

Does Constellation (CON-001) use AI or machine learning?

Yes. Constellation (CON-001) (K241280) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Constellation (CON-001)?

THINQ (K192051); AMRA Profiler (K211983).

Who can help prepare an FDA 510(k) submission like Constellation (CON-001)?

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 Constellation (CON-001) 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.

Constellation (CON-001)

K241280 · Q Bio, Inc. · QIH · Sep 12, 2024 · Radiology

Device Facts

Record ID	K241280
Device Name	Constellation (CON-001)
Applicant	Q Bio, Inc.
Product Code	QIH · Radiology
Decision Date	Sep 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Anatomical segmentation of lungs, liver, spleen, kidneys, muscle, and fat	Convolutional neural networks	—	—	—	—	—	3 (radiologists)
Segmentation of brain cortical and subcortical regions	Non-AI based algorithms	—	—	—	—	—	3 (radiologists)

Indications for Use

Constellation is a software application that stitches together MR images, automatically labels, and calculates quantitative measurements for anatomical regions. The device outputs are designed to be used by clinicians as a clinical decision support tool and are not to be used in triage events, emergency medicine, or critical care. It is not intended to be a sole source of medical diagnosis. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices.

Device Story

Automated image post-processing software; inputs whole-body DICOM MR images (T1 MPRAGE, 2-point/6-point DIXON) from GE MR450W; stitches overlapping anatomical stations; segments organs (lungs, liver, spleen, kidneys), brain structures, and tissues (lower limb muscles, visceral/subcutaneous adipose); utilizes non-AI algorithms and convolutional neural networks (CNNs) for segmentation; produces PDF report with quantitative measurements and alpha-blended anatomical visualizations; operates on internal server/off-the-shelf Apple hardware; used by clinicians as decision support; assists in assessment; does not provide automated diagnosis; clinician retains final diagnostic responsibility.

Clinical Evidence

Bench testing only. Evaluated segmentation accuracy (Dice Similarity Coefficient, mean percent absolute difference) for lungs, liver, spleen, kidneys, muscle, fat, and brain structures. Repeatability assessed via test-retest on identical scans. Ground truth established via manual segmentation inter-rater/intra-rater variability studies. Software verification and human factors/usability testing performed per FDA guidance; all tests passed.

Technological Characteristics

Software-only device; operates on off-the-shelf Apple hardware; DICOM input; non-AI algorithms for brain, lungs, femur, lower limb muscles, SAT; CNNs for kidneys, spleen, liver, VAT; supports T1 MPRAGE, 2-point/6-point DIXON sequences; internal server hosting; automated quality control (scan protocol verification, coordinate encoding, image quality thresholds).

Indications for Use

Indicated for non-invasive labeling and calculation of quantitative measurements for anatomical regions in healthy adult patients using whole-body DICOM MR images from a GE MR450W. Clinician-use only; not for triage, emergency, or critical care.

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

THINQ (K192051)
AMRA Profiler (K211983)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Q Bio, Inc. M. Jason Brooke MSE, JD, CSQE, Brooke & Associates 1411 Industrial Road San Carlos, California 94070 September 12, 2024 Re: K241280 Trade/Device Name: Constellation (CON-001) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ, LNH Dated: August 15, 2024 Received: August 15, 2024 Dear M. Jason Brooke: 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" {1}------------------------------------------------ (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 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 (OS) 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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-regulatory {2}------------------------------------------------ assistance/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, Jessica Lamb Jessica Lamb, Ph.D. Assistant Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K241280 Device Name Constellation (CON-001) #### Indications for Use (Describe) Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions. Constellation utilizes DICOM MR images gathered on a GE MR450W that encompass the whole-body. It is intended to be used for healthy adult patients. Clinicians may use Constellation as a clinical decision support tool, but it is not to be used in triage events, emergency medicine, or critical care. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Q.bio. The logo consists of a large, blue circle with a smaller blue circle below and to the right of it. To the right of the circle is the word "bio" in black, lowercase letters. The logo is simple and modern, with a focus on the company's name. Q Bio, Inc. 1411 Industrial Road San Carlos, CA 94070 USA ## 510(k) Summary (Information provided in conformance with 21 CFR 807.92) | 510(k) Submitter: | Q Bio, Inc. 1411 Industrial Road San Carlos, CA 94070 USA. | | | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--| | Contact Person: | M. Jason Brooke, MSE, JD, CSQE Brooke & Associates Email: jbrooke@devicecounsel.com Phone: +1 202-258-1422 | | | | Additional Correspondents: | Clarissa Shen Chief Operating Officer Email: clarissa.shen@q.bio Phone: +1 415-967-7622 | | | | Date Summary Prepared | April 26, 2024 | | | | Trade Name: | Constellation | | | | Common Name: | Automated radiological image processing software | | | | Classification: | Class II | | | | Regulation Number: | 21 CFR 892.2050 | | | | Product Code: | QIH - Automated Radiological Image Processing Software LLZ - System, Image Processing, Radiological | | | | Review Panel: | Radiology | | | | Predicate Devices: | Primary Predicate: Manufacturer: CorticoMetrics, LLC Trade Name: THINQ 510(k) Number: K192051 Product Code: LLZ | Secondary Predicate: Manufacturer: AMRA Medical AB Trade Name: AMRA Profiler 510(k) Number: K211983 Product Code: LNH | | {5}------------------------------------------------ Q Bio, Inc. 1411 Industrial Road San Carlos, CA 94070 USA Image /page/5/Picture/1 description: The image shows the logo for Q.bio. The logo consists of a large, blue circle with a smaller blue circle below it, resembling the letter 'Q'. To the right of the circle is the word 'bio' in black, lowercase letters. The logo is simple and modern, using a clean font and a bright color. # 1. Device Description Constellation is an automated image post-processing software application used in a clinical MRI setting. Constellation combines MR images from overlapping anatomical stations to segment anatomical regions and provide associated quantitative measurements for whole-body patient anatomy. These anatomical regions include the lower limb muscles, visceral adipose tissue, subcutaneous adipose tissue, kidneys, liver, spleen, lungs, and brain structures. A PDF report contains quantified measurements alonqside a whole-body visualization and segmented label images. Constellation provides alpha-blending of the anatomical image with the corresponding labels in the final report. This process combines one stitched output (background) with another (foreground) to create a final anatomical label with both grayscale and color resulting from the blending of the background (greyscale) and foreground label. Constellation is a tool intended to assist trained physicians in the assessment of MR images of the whole body. The software is not designed to provide any automated detection or diagnosis. Physicians retain the ultimate responsibility for making any diagnosis from the presented images based on their standard practices and patient background, clinical history, symptoms, and other diagnostic information. # 2. Intended Use Constellation is a software application that stitches together MR images, automatically labels, and calculates quantitative measurements for anatomical regions. The device outputs are designed to be used by clinicians as a clinical decision support tool and are not to be used in triage events, emergency medicine, or critical care. It is not intended to be a sole source of medical diagnosis. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. # 3. Indications for Use Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions. Constellation utilizes DICOM MR images gathered on a GE MR450W that encompass the whole-body. It is intended to be used for healthy adult patients. Clinicians may use Constellation as a clinical decision support tool, but it is not to be used in triage events, emergency medicine, or critical care. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Q.bio. The logo consists of a large blue circle with a smaller blue circle below and to the right of it. To the right of the circle is the word "bio" in black, sans-serif font. The logo is simple and modern, with a focus on the company's name. #### Summary of Technological Characteristics Comparison 4. A summary of the comparison between technological characteristics of Constellation and its provided in Table 1 below. | | Q Bio, Inc. (Subject Device) | CorticoMetrics LLC (Primary Predicate) | AMRA Medical AB (Secondary Predicate) | Differences | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Product Name | Constellation | THINQ | AMRA Profiler | N/A | | 510(k) Number | K241280 | K192051 | K211983 | N/A | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1000 | Same as primary predicate | | Regulation Description | Medical Image Management and Processing System | Medical Image Management and Processing System | Magnetic Resonance Diagnostic System | Same as primary predicate | | Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Nuclear Magnetic Resonance Imaging | Same as primary predicate | | Classification | II | II | II | Same | | Product Code | QIH, LLZ | LLZ | LNH | Similar to predicate | | Indications for Use | Constellation is intended for non- invasive labeling and calculation of quantitative measurements for anatomical regions. Constellation utilizes DICOM MR images gathered on a GE MR450W that encompass the whole-body. It is | THINQ is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. Volumetric measurements | Indicated for use as a magnetic resonance diagnostic device software application for non-invasive fat and muscle evaluation that enables the generation, display and review of 2D | Same | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Q.bio. The logo consists of a large blue circle with a smaller blue circle inside it, followed by the text "bio" in black. The "bio" text is written in a sans-serif font. | | Q Bio, Inc. (Subject Device) | CorticoMetrics LLC (Primary Predicate) | AMRA Medical AB (Secondary Predicate) | Differences | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | | intended to be used for healthy adult patients. Clinicians may use Constellation as a clinical decision support tool, but it is not to be used in triage events, emergency medicine, or critical care. A clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. | may be compared to reference percentile data. | magnetic resonance medical image data. Designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the body including the liver. Other physical parameters derived from the images may also be produced. Provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of fat fraction in the liver, T2, and muscle volume. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | | | User | Clinicians | Medical professionals | Medical professionals | Similar | | Hosting platform | Internal server | On-site hosting or internal server | Internal server | Same | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Q.bio. The logo consists of a large blue circle with a smaller blue circle inside it, followed by the word "bio" in black sans-serif font. The logo is simple and modern, with a focus on the company's name. | | Q Bio, Inc. (Subject Device) | CorticoMetrics LLC (Primary Predicate) | AMRA Medical AB (Secondary Predicate) | Differences | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------| | Image Modality | MR | MR | MR | Same | | Design | | | | | | Operating System | Mac | Linux | Linux | Similar | | Physical Characteristics | Software package. Operates on off-the-shelf hardware (Apple) | Software package. Operates on off-the-shelf hardware (multiple vendors) | Software package | Same | | Technology | Non-Al based Algorithms (brain, lungs, femur, lower limb muscles, SAT) Convolutional neural networks (kidneys, spleen, liver, VAT) | Non-Al based Algorithms | Non-Al based Algorithms | Similar | | Safety | • Automated quality control functions: • Scan protocol verification • Accurate patient coordinate system encoding • Image quality threshold checks • Results are reviewed by a trained quality assurance team and a clinician | • Automated quality control functions: • Scan sequence (protocol) checks • Atlas alignment checks • Cortical surface checks • Result validity checks • Results must be reviewed by a trained clinician | • Image quality issues are described and presented in the report • Automatic sequence protocol conformance check | Same | | Features | | | | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Q Bio. The logo consists of a large blue circle with a smaller blue circle below it, followed by the text "bio" in black. The text is in a sans-serif font and is aligned to the right of the circle. | | Q Bio, Inc. (Subject Device) | CorticoMetrics LLC (Primary Predicate) | AMRA Medical AB (Secondary Predicate) | Differences | |--------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------|-------------| | Anatomical Area of Interest | Head and Whole Body | Head | Whole Body | Same | | Alpha-Blended Color Images | Yes | Yes | Yes | Same | | User Access Point | Post-processing application | Post-processing application | Post-processing application | Same | | Image Input | DICOM | DICOM | DICOM | Same | | Intensity Normalization | Equalize station intensity: optional | Equalize station intensity: Yes | Equalize station intensity: Yes | Similar | | Registration | Atlas based registration for segmentation of brain regions and leg muscles. | Automatic registration of brain segmentation atlas to the input image. | Registration for leg muscle segmentation. | Similar | | Acquisition plane | Axial, Sagittal | Sagittal | Axial | Same | | Sequence compatibility | T1 MPRAGE, 2-point DIXON, 6- point DIXON | T1 MPRAGE | 2-point DIXON, 6-point DIXON | Same | | Output | ● PDF report with quantitative measurements including | ● PDF report with volumetric measurements | ● PDF report with volumetric measurements | Same | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Q.bio. The logo consists of a large blue circle with a smaller blue circle inside it, followed by the text "bio" in black. The logo is simple and modern, with a focus on the company's name. | | Q Bio, Inc. (Subject Device) | CorticoMetrics LLC (Primary Predicate) | AMRA Medical AB (Secondary Predicate) | Differences | |---------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------| | | • organ, muscle, and fat volumes • Includes segmented color overlays and structures | • Includes segmented color overlays and structures • Automatically compares results to reference percentile data • DICOM images with segmentation overlays | • Body composition profile measurements: subcutaneous and visceral fat volume, muscle fat, muscle volume and liver fat | | | Export Format | PDF | PDF and DICOM images | PDF | Same | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Q.bio. The logo consists of a large blue circle with a smaller blue circle below it, followed by the text "bio" in black. The "Q" is stylized to resemble a circle with a dot, and the overall design is clean and modern. #### Performance Testing 5. The following clinical and non-clinical tests were performed to evaluate Constellation's performance: - . Segmentation accuracy of the lungs, liver, spleen, kidneys, muscle, and fat (visceral and subcutaneous) is evaluated using the Dice Similarity Coefficient (DSC) and mean percent absolute difference as primary and secondary figures of merit (FOM). - . Segmentation accuracy for brain cortical/subcortical regions is evaluated via mean percent absolute difference and Pearson's correlation coefficient as the primary and secondary FOMs. - Liver Volume of Interest (VOI) placement is evaluated via majority voting of three . radiologists. - . Device repeatability is evaluated by calculating the DSC and mean percent absolute difference for the same MRI scans passed twice through Constellation. - Test-retest measurement repeatability is evaluated using the mean percent absolute difference and Pearson's correlation coefficient as the primary and secondary FOMs. - Manual segmentations are established as ground-truth via inter-rater and intra-rater ● variability studies. The variability in manual segmentations will be evaluated via DSC. - Software verification testing was conducted for Constellation to validate it for its intended ● use according to recommendations outlined in "General Principles of Software Validation, Guidance for Industry and FDA Staff". The Constellation software demonstrated passing results on all applicable unit, integration, and requirements testing. - Software usability testing was conducted for Constellation to validate it for its intended use . according to the FDA guidance titled: "Applying Human Factors and Usability Engineering to Medical Devices". The Constellation software demonstrated passing results in the applied usability testing. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. A full description of the software functionality, device hazard analysis, software requirements, verification, validation, and performance testing is provided in this submission. # 6. Conclusions The performance testing presented shows that Constellation is as safe, as effective, and performs as well as the predicate devices. Any technological differences between Constellation and its predicate devices do not raise new questions of safety and effectiveness. Therefore, Constellation is substantially equivalent to its predicate devices.

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