(128 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the Constellation (CON-001) device, based on the provided text:
Acceptance Criteria and Device Performance Study
The Constellation device, an automated image post-processing software for whole-body MR images, underwent various performance tests to demonstrate its safety and effectiveness. The primary metrics used for evaluating segmentation accuracy were the Dice Similarity Coefficient (DSC) and mean percent absolute difference.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria with specific numerical thresholds for each metric. Instead, it describes what was evaluated and the metrics used. The conclusion states that the device "performs to its intended use" and "is as safe, as effective, and performs as well as the predicate devices." Without specific numerical targets or results mentioned in the provided text, the "Reported Device Performance" column reflects what was measured rather than specific values achieved against a predefined threshold.
| Metric/Evaluation Area | Acceptance Criteria (as implied/evaluated) | Reported Device Performance (as stated) |
|---|---|---|
| Segmentation Accuracy (Lungs, Liver, Spleen, Kidneys, Muscle, Visceral & Subcutaneous Fat) | Performance deemed acceptable for clinical use, comparable to predicate devices. | Evaluated using Dice Similarity Coefficient (DSC) as the primary figure of merit (FOM) and mean percent absolute difference as the secondary FOM. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. The device is claimed to be "as safe, as effective, and performs as well as the predicate devices." |
| Segmentation Accuracy (Brain Cortical/Subcortical Regions) | Performance deemed acceptable for clinical use, comparable to predicate devices. | Evaluated via mean percent absolute difference as the primary FOM and Pearson's correlation coefficient as the secondary FOM. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. The device is claimed to be "as safe, as effective, and performs as well as the predicate devices." |
| Liver Volume of Interest (VOI) Placement | Placement accuracy acceptable per expert adjudication. | Evaluated via majority voting of three radiologists. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. The device is claimed to be "as safe, as effective, and performs as well as the predicate devices." |
| Device Repeatability (same MRI scans passed twice) | Consistent results; acceptable DSC and mean percent absolute difference. | Evaluated by calculating the DSC and mean percent absolute difference for the same MRI scans passed twice through Constellation. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. The device is claimed to be "as safe, as effective, and performs as well as the predicate devices." |
| Test-Retest Measurement Repeatability | Consistent measurements; acceptable mean percent absolute difference and Pearson's correlation coefficient. | Evaluated using the mean percent absolute difference and Pearson's correlation coefficient as the primary and secondary FOMs. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. The device is claimed to be "as safe, as effective, and performs as well as the predicate devices." |
| Manual Segmentation Variability (Ground Truth) | Acceptable inter-rater and intra-rater variability for manual segmentations. | Evaluated via DSC in inter-rater and intra-rater variability studies. This study established the ground truth. The test results demonstrated that Constellation performs to its intended use and does not introduce new questions of safety or effectiveness. The device is claimed to be "as safe, as effective, and performs as well as the predicate devices." |
| Software Verification Testing | Passing results on all applicable unit, integration, and requirements testing. | Demonstrated passing results on all applicable unit, integration, and requirements testing according to "General Principles of Software Validation, Guidance for Industry and FDA Staff". |
| Software Usability Testing | Passing results for intended use. | Demonstrated passing results in the applied usability testing according to "Applying Human Factors and Usability Engineering to Medical Devices". |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set.
The data provenance is also not explicitly stated beyond mentioning that the device "utilizes DICOM MR images gathered on a GE MR450W that encompass the whole-body" and is intended for "healthy adult patients." Whether the data was retrospective or prospective, or the country of origin, is not mentioned.
3. Number of Experts and Qualifications for Ground Truth
The document specifies:
- Number of experts: 3 (for Liver Volume of Interest (VOI) placement evaluation)
- Qualifications of experts: Radiologists. No further details (e.g., years of experience) are provided.
For manual segmentations (used to establish ground truth), it mentions "inter-rater and intra-rater variability studies," implying multiple raters, but does not specify the number or qualifications of these raters.
4. Adjudication Method for the Test Set
For the Liver Volume of Interest (VOI) placement evaluation, the adjudication method was majority voting of three radiologists.
For other segmentation accuracy evaluations and manual segmentations, the document does not explicitly state an adjudication method (like 2+1 or 3+1), but only mentions "inter-rater and intra-rater variability studies."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to measure the improvement of human readers with AI assistance versus without AI assistance. The study focuses on the standalone performance and repeatability of the device, as well as the establishment of its ground truth.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document describes several performance tests, including:
- Segmentation accuracy of various anatomical regions (lungs, liver, spleen, kidneys, muscle, fat, brain structures) using DSC, mean percent absolute difference, and Pearson's correlation coefficient.
- Liver VOI placement evaluation.
- Device repeatability and test-retest measurement repeatability.
These evaluations were conducted on the algorithm directly, without a human-in-the-loop component being assessed as part of the primary performance metrics for the device itself. The device is positioned as a "clinical decision support tool," with the clinician retaining ultimate responsibility.
7. Type of Ground Truth Used
The ground truth for segmentation accuracy was established through manual segmentations by experts. This is indicated by: "Manual segmentations are established as ground-truth via inter-rater and intra-rater variability studies."
For Liver VOI placement, ground truth was implicitly established by the majority voting of three radiologists.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established. It only describes the establishment of ground truth for the test set through manual segmentations and expert review.
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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"
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(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
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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
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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 RoadSan Carlos, CA 94070 USA. | ||
|---|---|---|---|
| Contact Person: | M. Jason Brooke, MSE, JD, CSQEBrooke & AssociatesEmail: jbrooke@devicecounsel.comPhone: +1 202-258-1422 | ||
| AdditionalCorrespondents: | Clarissa ShenChief Operating OfficerEmail: clarissa.shen@q.bioPhone: +1 415-967-7622 | ||
| Date SummaryPrepared | April 26, 2024 | ||
| Trade Name: | Constellation | ||
| Common Name: | Automated radiological image processing software | ||
| Classification: | Class II | ||
| RegulationNumber: | 21 CFR 892.2050 | ||
| Product Code: | QIH - Automated Radiological Image Processing SoftwareLLZ - System, Image Processing, Radiological | ||
| Review Panel: | Radiology | ||
| Predicate Devices: | Primary Predicate:Manufacturer: CorticoMetrics, LLCTrade Name: THINQ510(k) Number: K192051Product Code: LLZ | Secondary Predicate:Manufacturer: AMRA Medical ABTrade Name: AMRA Profiler510(k) Number: K211983Product Code: LNH |
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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 ImageManagement andProcessing System | Medical ImageManagement andProcessing System | Magnetic ResonanceDiagnostic System | Same as primary predicate |
| Classification Name | System, Image Processing,Radiological | System, Image Processing,Radiological | System, Nuclear MagneticResonance 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 calculationof quantitative measurements foranatomical regions. Constellationutilizes DICOM MR imagesgathered on a GE MR450W thatencompass the whole-body. It is | THINQ is intended forautomatic labeling,visualization and volumetricquantification ofsegmentable brain structuresfrom a set of MR images.Volumetric measurements | Indicated for use as amagnetic resonancediagnostic device softwareapplication for non-invasivefat and muscle evaluationthat 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 healthyadult patients. Clinicians may useConstellation as a clinicaldecision support tool, but it is notto be used in triage events,emergency medicine, or criticalcare. A clinician retains theultimate responsibility for makingthe pertinent diagnosis based ontheir standard practices. | may be compared toreference percentile data. | magnetic resonance medicalimage data.Designed to utilize DICOM3.0 compliant magneticresonance image datasets,acquired from compatibleMR Systems, to display theinternal structure of the bodyincluding the liver. Otherphysical parameters derivedfrom the images may also beproduced.Provides a number ofquantification tools, such asRegion of Interest (ROI)placements, to be used forthe assessment ofregions of an image toquantify liver tissuecharacteristics, including thedetermination of fat fractionin the liver, T2, and musclevolume.These images and thephysical parameters derivedfrom the images, wheninterpreted by a trainedclinician, yield informationthat may assist in diagnosis. | ||
| User | Clinicians | Medical professionals | Medical professionals | Similar |
| Hosting platform | Internal server | On-site hosting or internalserver | 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 onoff-the-shelf hardware (Apple) | Software package. Operateson 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 controlfunctions:• Scan protocol verification• Accurate patientcoordinate systemencoding• Image quality thresholdchecks• Results are reviewed by atrained quality assurance teamand a clinician | • Automated quality controlfunctions:• Scan sequence(protocol) checks• Atlas alignmentchecks• Cortical surfacechecks• Result validitychecks• Results must be reviewedby a trained clinician | • Image quality issues aredescribed and presented inthe report• Automatic sequenceprotocol conformance check | Same |
| Features |
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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 ofInterest | Head and Whole Body | Head | Whole Body | Same |
| Alpha-Blended ColorImages | 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 forsegmentation of brain regionsand leg muscles. | Automatic registration ofbrain segmentation atlas tothe input image. | Registration for leg musclesegmentation. | Similar |
| Acquisition plane | Axial, Sagittal | Sagittal | Axial | Same |
| Sequence compatibility | T1 MPRAGE, 2-point DIXON, 6-point DIXON | T1 MPRAGE | 2-point DIXON, 6-pointDIXON | Same |
| Output | ● PDF report withquantitativemeasurements including | ● PDF report withvolumetricmeasurements | ● PDF report withvolumetricmeasurements | Same |
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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 fatvolumes• Includes segmentedcolor overlays andstructures | • Includes segmentedcolor overlays andstructures• Automaticallycompares results toreference percentiledata• DICOM images withsegmentationoverlays | • Body compositionprofilemeasurements:subcutaneous andvisceral fat volume,muscle fat, musclevolume and liver fat | ||
| Export Format | PDF and DICOM images | Same |
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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.
§ 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).