(128 days)
Not Found
Yes
The document explicitly states that the device uses "Convolutional neural networks" for segmentation of specific organs (kidneys, spleen, liver, VAT), which is a type of deep learning, a subset of machine learning.
No
Constellation is a clinical decision support tool that assists in the assessment of MR images by providing quantitative measurements, but it is not intended for diagnosis, treatment, or patient management, which are characteristic functions of a therapeutic device.
No
The device is described as a "clinical decision support tool" and specifically states it "is not designed to provide any automated detection or diagnosis." It emphasizes that "A clinician retains the ultimate responsibility for making the pertinent diagnosis." While it provides quantitative measurements for anatomical regions, its role is to assist, not to diagnose.
Yes
The device is described as an "automated image post-processing software application" and the description focuses solely on software functionalities like image processing, segmentation, and reporting. While it uses input from an MR scanner, the device itself is the software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Constellation's Function: Constellation processes in vivo (within the living body) MR images. It analyzes images acquired directly from the patient's body using an MRI machine. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "non-invasive labeling and calculation of quantitative measurements for anatomical regions" using "DICOM MR images gathered on a GE MR450W that encompass the whole-body." This is image processing, not laboratory testing of biological samples.
Therefore, Constellation falls under the category of medical image processing software, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states "Not Found".
Intended Use / 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.
Product codes
QIH, LLZ, LNH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Convolutional neural networks (kidneys, spleen, liver, VAT)
Input Imaging Modality
MR
Anatomical Site
Head and Whole Body
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Clinicians, clinical MRI setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
- 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dice Similarity Coefficient (DSC), mean percent absolute difference, Pearson's correlation coefficient.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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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)
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)
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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.
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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 |
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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 |
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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.