Who is the manufacturer of uAI Portal?

Shanghai United Imaging Intelligence Co., Ltd. filed the 510(k) submission for uAI Portal (K240411).

What is the FDA product code for uAI Portal?

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

What is the regulatory pathway for uAI Portal?

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

Does uAI Portal use AI or machine learning?

Yes. uAI Portal (K240411) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like uAI Portal?

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 uAI Portal 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.

uAI Portal

K240411 · Shanghai United Imaging Intelligence Co., Ltd. · QIH · Sep 6, 2024 · Radiology

Device Facts

Record ID	K240411
Device Name	uAI Portal
Applicant	Shanghai United Imaging Intelligence Co., Ltd.
Product Code	QIH · Radiology
Decision Date	Sep 6, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

uAI Portal is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The Lower Extremity Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating CTA images of lower extremities. The Head and Neck Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with head and neck CTA. The Coronary Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CCTA. The Pulmonary Artery Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CTPA. The Aorta Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with aorta CTA.

Device Story

uAI Portal is a software solution for viewing, manipulating, and storing medical images (DICOM 3.0). It processes CT studies using AI-based segmentation algorithms to assist clinicians in interpreting anatomical and functional datasets. The device supports various display formats (VR, MIP, MPR, Probe, CPR, SCPR). A trained, licensed physician uses the software to review segmented results, perform measurements (e.g., stenosis), and evaluate vascular structures. The system operates within healthcare institutions, loading images into memory for analysis and allowing users to save results to PACS or print them. By automating vessel and organ segmentation, the device aims to improve the efficiency and consistency of diagnostic workflows for vascular and cardiac examinations.

Clinical Evidence

No clinical studies were required. Performance was validated using 150 US-collected CT images covering diverse demographics (age 19-91, gender, equipment, artifacts, anatomical variations). The AI-based segmentation algorithms were compared against ground truth established by two radiologists and an adjudicator. Performance was measured using the Dice coefficient, with average results ranging from 0.846 to 0.980 across various vessel and heart segmentation tasks, demonstrating high consistency.

Technological Characteristics

Standalone software for medical image management and processing. Utilizes AI-based automatic segmentation algorithms. Supports DICOM 3.0 connectivity. Features include VR, MIP, MPR, Probe, CPR, and SCPR display formats. Complies with NEMA PS 3.1-3.20 (DICOM), ISO 14971 (risk management), and IEC 62304 (software lifecycle).

Indications for Use

Indicated for viewing, manipulation, and evaluation of CT imaging datasets (CTA, CCTA, CTPA) for lower extremity, head and neck, coronary, pulmonary artery, and aorta applications in healthcare institutions.

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

uWS-CT (K183170)

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Submission Summary (Full Text)

{0}------------------------------------------------ September 6, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, conveying the organization's role in regulating food and drugs. Shanghai United Imaging Intelligence Co., Ltd. Xiaojing Zhao Ouality & Regulatory Manager No. 701 Yunjin Road, Xuhui District Shanghai, 200232 China Re: K240411 Trade/Device Name: uAI Portal Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: August 14, 2024 Received: August 15, 2024 Dear Xiaojing Zhao: 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. 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 mediation-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, Samal for Jessica Lamb, Ph.D. Assistant Director Imaging Software Team 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 Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) #### K240411 Device Name uAl Portal Indications for Use (Describe) uAl Portal is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation of examinations within healthcare institutions. It has the following additional indications: The Lower Extremity Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating CTA images of lower extremities. The Head and Neck Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with head and neck CTA. The Coronary Analysis is intended to provide a tool for viewing, manipulating imaging datasets acquired with CCTA. The Pulmonary Artery Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CTPA. The Aorta Analysis is intended to provide a tool for viewing, and evaluating imaging datasets acquired with aorta CTA. 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 text "K240411" in a large, bold font at the top. Below the text is a logo for "United Imaging Intelligence" with the same text in Chinese below it. The logo consists of a series of blue and green triangles arranged in a column. # 510 (k) SUMMARY ## 1. Date of Preparation: February 8, 2024 ### 2. Sponsor Identification ### Shanghai United Imaging Intelligence Co., Ltd. No. 701 Yunjin Road, Xuhui District, Shanghai, 200232, PEOPLE'S REPUBLIC OF CHINA Contact Person: Xiaojing Zhao Position: Regulatory Specialist Tel: +86-021-67076888-5386 Email: xiaojing.zhao@uii-ai.com Primary Contact Correspondent: MCRA Digital Health Contact Person: Nima Akhlaghi Position: Director, Digital Health, AI & Imaging Center Lead Tel: 202-742-3889 Email: nakhlaghi@mcra.com ### 3. Identification of Proposed Device Trade Name: uAI Portal Common Name: Medical image management and processing system Model(s): uAI Portal Regulatory Information Classification Name: Medical image management and processing system Classification: II Product Code: QIH, LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology ### 4. Identification of Predicate Device(s) Predicate Device {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo with text. On the left side of the image, there is a logo that consists of several geometric shapes arranged in a triangular pattern. The shapes are colored in shades of blue and green. To the right of the logo, there is the text "United Imaging Intelligence" in English, followed by the same text in Chinese. The text is in a simple, sans-serif font. 510(k) Number: K183170 Device Name: uWS-CT ### 5. Device Description uAI Portal is a comprehensive software solution designed to process, review and analyze CT studies. It can transfer images in DICOM 3.0 format over a medical imaging network or local file system. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including VR, MIP, MPR, Probe, CPR, and SCPR. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice. uAI Portal contains the following applications: - The Lower Extremity Vessel Analysis ● - . The Head and Neck Vessel Analysis - . The Coronary Analysis - . The Pulmonary Artery Analysis - . The Aorta Analysis {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized cluster of triangles in shades of blue and green. To the right of the geometric shape is the company name, "United Imaging Intelligence," written in English, followed by the same name written in Chinese characters below it. ### 6. Indications for use uAI Portal is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: - . The Lower Extremity Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating CTA images of lower extremities. - . The Head and Neck Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with head and neck CTA. - . The Coronary Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CCTA. - . The Pulmonary Artery Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CTPA. - . The Aorta Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with aorta CTA. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric design on the left and the company name on the right. The geometric design is made up of several small triangles arranged in a pyramid shape, with the colors ranging from dark blue to light green. The company name is written in both English and Chinese, with "United Imaging Intelligence" on top and "联影智能" below. ### 7. Summary of Technological Characteristics uAI Portal offers a fast and user-friendly solution for reconstructing medical images by utilizing automatic segmentation results generated by artificial intelligence algorithms. The system parses DICOM images, extracts some tags and then fill the information to database. Datachecking is performed based on the information to verify whether the data can be processed by any of the application. Then the algorithms will be called to process the images in memory and output the segmented results. The segmented results will be stored in hard drive. The system uses database to retrieve the information and record some operation status. Once users select any data and choose one application, the application will start and load the images files to memory. The original images and the processing results can be displayed in the software interface. Various types of views depending on the selected application are displayed by respective algorithms in the software interface. Basic operations like zooming, panning, adjusting window, and measurements can be performed on the displayed images. Users have the options to save images or results to PACS for storage or send them to Filming for printing. Additionally, user configuration is provided, allowing users to customize their settings in each application. Both the proposed and predicate device have the similar general information, such as Device Classification Name, Product Code, Classification Panel, Intended Use described in Table 1. The proposed and predicate device also have the same advanced applications in following: - Lower Extremity Vessel Analysis - Head and Neck Vessel Analysis - Coronary Analysis - . Pulmonary Artery Analysis - Aorta Analysis The differences between the proposed and the predicate device are listed as follows: - The CT Vessel Analysis application of the predicate device includes the Aorta . Analysis application, Head and Neck Vessel Analysis application, Lower Extremity Vessel Analysis application and Pulmonary Artery Analysis {8}------------------------------------------------ Image /page/8/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric design on the left, resembling a stylized pyramid or a collection of angled shapes in shades of blue and green. To the right of the geometric design is the text "United Imaging Intelligence" in a simple, sans-serif font, followed by the same name in Chinese characters below. application of the proposed device; The CT Heart application of the predicate device offer similar functions as Coronary Analysis application of the proposed device. - The CT Vessel Analysis application of the predicate device provides combined . segmentation results of vessels and inseparable parts of organs, whereas the proposed device provides segmentation results of vessels in the Aorta Analysis application and Pulmonary Artery Analysis application. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains a logo for United Imaging Intelligence. The logo consists of two parts: a geometric shape on the left and text on the right. The geometric shape is made up of several triangles arranged in a pyramid-like structure, with a gradient of blue and green colors. The text on the right reads "United Imaging Intelligence" in English, followed by "联影智能" in Chinese. The text is in a simple, sans-serif font and is aligned to the left. ### Table 1 Comparison of general information | Item | Proposed Device uAI Portal | Predicate Device uWS-CT(K183170) | Remark | |----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification Name | Medical image management and processing system | Picture Archiving and Communications System | The FDA has changed its regulatory classification of PACS (Picture Archiving and Communication Systems), referring to it now as MIMPS (medical image management and processing systems) as part of amended regulatory classification changes made for radiology-specific software. | | Product Code | QIH, LLZ | LLZ | Both LLZ and QIH are product code of Medical image management and | | Item | Proposed Device uAI Portal | Predicate Device uWS-CT(K183170) | Remark | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Device Class | II | II | Same | | Classification Panel | Radiology | Radiology | Same | | Advanced Application | Yes | Yes | processing system, the difference between them is use different algorithms. | | Item | Proposed Device | Predicate Device | Remark | | | uAI Portal | uWS-CT(K183170) | | | | | | device. | | Intended Use | uAI Portal is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The Lower Extremity Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating CTA images of lower extremities. The Head and Neck Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with head and neck CTA. | uWS-CT is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow- up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to | The intended use is decreased. The predicated device includes more applications, which is discussed in the following sections, than the proposed device. This difference will not impact the safety and effectiveness of the device. | | Item | Proposed Device uAI Portal | Predicate Device uWS-CT(K183170) | Remark | | | The Coronary Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CCTA. The Pulmonary Artery Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with CTPA. The Aorta Analysis is intended to provide a tool for viewing, manipulating, and evaluating imaging datasets acquired with aorta CTA. | enable easy visualization and efficient evaluation of CT volume data sets of the colon. The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies. The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images. The Inner view application is intended to perform a | | | Item | Proposed Device uAI Portal | Predicate Device uWS-CT(K183170) | Remark | | | | virtual camera view through hollow structures (cavities), such as vessels. The CT Lung Density Analysis application is intended to segment pulmonary, lobes, and airway, providing the user quantitative parameters, structure information to evaluate the lung and airway. The CT Brain Perfusion application is intended to calculate the parameters such as: CBV, CBF, etc. in order to analyze functional blood flow information about a region of interest (ROI) in the brain. The CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. | | | Item | Proposed Device | Predicate Device | Remark | | | uAI Portal | uWS-CT(K183170) The CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score. The CT Dynamic Analysis application is intended to provide visualization of the CT datasets over time with the 3D/4D display modes. The CT Bone Structure Analysis application is intended to provide visualization and labels for the ribs and spine, and support batch function for intervertebral disk. The CT Liver Evaluation application is intended to provide processing and visualization for liver segmentation and vessel extraction. It also provides a tool for the user to perform liver separation and residual liver segments evaluation. | | Page 6 of 27 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of several triangles in different shades of blue and green. The company name is written in English and Chinese. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized pyramid or a collection of triangles in shades of blue and green. To the right of the geometric shape is the text "United Imaging Intelligence" in English, followed by the same name in Chinese characters. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric design on the left, resembling a stylized cluster of triangles in varying shades of blue and green. To the right of the geometric design is the text "United Imaging Intelligence" in English, followed by the same name in Chinese characters. The number 1 is located at the bottom left of the image. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of two parts: a geometric shape on the left and the company name on the right. The geometric shape is made up of several triangles in shades of blue and green. The company name is written in both English and Chinese. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric design on the left, resembling a stylized cluster of triangles in shades of blue and green. To the right of the geometric design, the text "United Imaging Intelligence" is written in English, followed by the Chinese characters "影响南". {15}------------------------------------------------ Image /page/15/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric design on the left, resembling a stylized cluster of angled shapes in shades of blue and green. To the right of the geometric design is the text "United Imaging Intelligence" in a sans-serif font, followed by the same name in Chinese characters below it. ### Table 2 SE Discussion for different Advanced Applications | Application | Function name | Proposed device uAI Portal Lower Extremity Vessel Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | |---------------------------------------|-----------------------|---------------------------------------------------------------------|------------------------------------------------------------------|--------| | Lower Extremity Vessel Analysis | Image Browsing | Yes | Yes | Same | | | Image Editing | Yes | Yes | Same | | | Vessel Segmentation | Yes | Yes | Same | | | Bone Segmentation | Yes | Yes | Same | | | Centerline Extraction | Yes | Yes | Same | | | ROI | Yes | Yes | Same | | | Measurement | Yes | Yes | Same | | | Stenosis Measurement | Yes | Yes | Same | | Application | Function name | Proposed device uAI Portal Lower Extremity Vessel Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | | | Print | Yes | Yes | Same | | | Archive | Yes | Yes | Same | | | User Configuration | Yes | Yes | Same | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image contains a logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized pyramid made of smaller squares in shades of blue and green. To the right of the geometric shape is the text "United Imaging Intelligence" in English, followed by the same name in Chinese characters. | Application | Function name | Proposed device uAI Portal Head and Neck Vessel Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | |----------------------------------|--------------------------|-------------------------------------------------------------------|------------------------------------------------------------------|--------| | Head and Neck Vessel Analysis | Image Browsing | Yes | Yes | Same | | Head and Neck Vessel Analysis | Image Editing | Yes | Yes | Same | | Application | Function name | Proposed device uAI Portal Head and Neck Vessel Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | | | Vessel Segmentation | Yes | Yes | Same | | | Bone Segmentation | Yes | Yes | Same | | | Centerline Extraction | Yes | Yes | Same | | | Measurement | Yes | Yes | Same | | | Print | Yes | Yes | Same | | | Archive | Yes | Yes | Same | | | User Configuration | Yes | Yes | Same | | Application | Function name | Proposed device uAI Portal Coronary Analysis | Predicate device uWS- CT(K183170) CT Heart | Remark | | Coronary Analysis | Image Browsing | Yes | Yes | Same | | | Image Editing | Yes | Yes | Same | | | Heart Segmentation | Yes | Yes | Same | | | Vessel Segmentation | Yes | Yes | Same | | | Centerline Extraction | Yes | Yes | Same | | | Measurement | Yes | Yes | Same | | | Stenosis Measurement | Yes | Yes | Same | | Application | Function name | Proposed device uAI Portal Coronary Analysis | Predicate device uWS- CT(K183170) CT Heart | Remark | | | Print | Yes | Yes | Same | | | Archive | Yes | Yes | Same | | | User Configuration | Yes | Yes | Same | {17}------------------------------------------------ Image /page/17/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric design on the left, resembling a stylized pyramid or a series of interconnected shapes, with a gradient of blue and green colors. To the right of the geometric design, the text "United Imaging Intelligence" is written in English, followed by the same name in Chinese characters. {18}------------------------------------------------ Image /page/18/Picture/0 description: The image contains a logo with the text "United Imaging Intelligence" and the Chinese characters "联影智能" underneath. To the left of the text is an abstract graphic composed of several geometric shapes, primarily triangles or trapezoids, arranged in a pyramid-like formation. The shapes are colored in a gradient of blues and greens, with the darker blues at the top transitioning to lighter greens at the bottom. The overall design appears to represent a company or organization focused on imaging and intelligence technologies. {19}------------------------------------------------ Image /page/19/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized pyramid made of small squares in shades of blue and green. To the right of the geometric shape is the text "United Imaging Intelligence" in English, with the words stacked on top of each other. Below the English text is the same name in Chinese characters. | Application | Function name | Proposed device uAI Portal Pulmonary Artery Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | |------------------------------|--------------------|---------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Pulmonary Artery Analysis | Image Browsing | Yes | Yes | Same | | | Image Editing | Yes | Yes | Same | | | Segmentation | Yes | Yes | The CT Vessel Analysis Application of | | Application | Function name | Proposed device uAI Portal Pulmonary Artery Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | | | | | | uWS-CT (K183170) provide vessel segmentation results with organs. The uAI Portal Pulmonary Artery Analysis offer segmentation results of vessels. For the | | | Measurement | Yes | Yes | Same | | | Print | Yes | Yes | Same | | | Archive | Yes | Yes | Same | | | User Configuration | Yes | Yes | Same | {20}------------------------------------------------ Image /page/20/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized pyramid or a collection of triangles, with a gradient of blue and green colors. To the right of the geometric shape is the text "United Imaging Intelligence" in English, followed by the same name in Chinese characters. {21}------------------------------------------------ Image /page/21/Picture/0 description: The image contains the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized mountain range or a series of stacked triangles, with a gradient of blue and green colors. To the right of the geometric shape is the text "United Imaging Intelligence" in English, followed by the same name in Chinese characters. | Application | Function name | Proposed device uAI Portal Aorta Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | |----------------|--------------------------|-------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Aorta Analysis | Image Browsing | Yes | Yes | Same | | Aorta Analysis | Segmentation | Yes | Yes | Organ segmentation results have slight difference due to the different applied algorithm of the predicate device and proposed device. For the evaluation of vessel, those other segmentation difference between the predicate device and proposed device will not impact the safety and effectiveness of the device | | | Centerline Extraction | Yes | Yes | Same | | | Measurement | Yes | Yes | Same | | | Lumen Diameter | Yes | Yes | Same | | Application | Function name | Proposed device uAI Portal Aorta Analysis | Predicate device uWS- CT(K183170) CT Vessel Analysis | Remark | | | Measurement | | | | | | Print | Yes | Yes | Same | | | Archive | Yes | Yes | Same | | | User Configuration | Yes | Yes | Same | {22}------------------------------------------------ Image /page/22/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric shape on the left, resembling a stylized pyramid or a collection of stacked triangles, with a gradient of blue and green colors. To the right of the geometric shape is the text "United Imaging Intelligence" in English, followed by the same name in Chinese characters. {23}------------------------------------------------ Image /page/23/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric design on the left and the company name on the right. The geometric design is made up of several triangles in shades of blue and green. The company name is written in English and Chinese, with "United Imaging Intelligence" on top and "联影智能" below. ### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility Not Applicable to the proposed device, because the device is stand-alone software. #### Electrical Safety and Electromagnetic Compatibility (EMC) Not Applicable to the proposed device, because the device is stand-alone software. #### Software Verification and Validation Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. Per FDA Guidance "GUIDANCE FOR THE CONTENT OF PRE-MARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN DEVICES", dated June 14, 2023, the Level of Concern of the software contained in the proposed device is determined to be: Basic Documentation Level. Those documentations include: - Software Description - Risk Management File - · Software Requirements Specification (SRS) - · Software Architecture Diagram - · Software Development Environment Description - Software Verification and Validation - · Software Version History - · Cybersecurity Documents #### Animal Study No animal study was required. #### Clinical Studies No clinical study was required. #### Performance Verification Algorithm training of uAI Portal software has been conducted on images collected from China as training dataset. The data set ensures a variety of data for the different {24}------------------------------------------------ gender, age, equipment and CT protocol. Algorithm verification has been conducted on US images. To validate the uAI Portal software from a clinical perspective, the Al-based segmentation Algorithm contained in the product underwent a scientific evaluation. The results of clinical data-based software validation for the proposed device demonstrated high consistency in comparison to the predicate device. Regarding the validation of the algorithm, the test data was used independently from training dataset. The algorithm testing of uAI Portal has been performed using 150 images collected from US, which covered different gender, age, ethnicity, equipment and CT protocol used to collect images. The information of demographic and equipment distribution was as follows: | Demographic information | Quantity/Years | | |-------------------------|------------------------------|-----| | Gender | Female | 73 | | | Male | 77 | | Age | Median | 66Y | | | Min | 19Y | | | Max | 91Y | | Equipment | SIEMENS | 55 | | | GE | 85 | | | TOSHIBA | 10 | | Artifacts | With artifacts | 33 | | | Without artifacts | 117 | | Anatomical variation | With anatomical variation | 30 | | | Without anatomical variation | 120 | ### Acceptance Criteria In order to verify the effectiveness of the algorithm in the proposed device, we compared the segmentation results with the ground truth. The validation type and acceptance criteria is shown below : | Validation Type | Application | Algorithm | Acceptance Criteria | |----------------------------------------------------------------------------------------------------|-------------------------|-----------------------------|------------------------| | Dice, DICE is defined as follows: $DICE = \frac{2 G \cap P }{ G + P }$ , where G is | Coronary Artery | Vessels segmentation | 0.85 | | | | Heart segmentation | 0.90 | | | Head and Neck Vessel | Head vessel segmentation | 0.85 | | | | Neck vessel | 0.90 | {25}------------------------------------------------ Image /page/25/Picture/0 description: The image shows the logo for United Imaging Intelligence. The logo consists of a geometric design on the left, resembling a cluster of angled blocks in shades of blue and green. To the right of the geometric design is the text "United Imaging Intelligence" in a clear, sans-serif font. Below the English text is the same company name in Chinese characters. | | | segmentation | | |-----------------------------------------------------------------|------------------------------|--------------------------|------| | the ground truth, and P is the segmentation result. | Aorta | Trunk segmentation | 0.90 | | | | Branches segmentation | 0.80 | | | Pulmonary Artery | Arteries segmentation | 0.85 | | | | Veins segmentation | 0.85 | | | Lower Extremity Artery | Arteries segmentation | 0.80 | During the ground truthing process, two Chinese radiologists, each with at least 5 years of clinical experience, independently annotated vessel mask for each patient case, resulting in two sets of annotations per case. Both radiologists are hospital employees and are independent from United Imaging. After completion, an American Board-Certified Radiology adjudicator with at least 10 years of clinical experience reviewed both sets of segmented images. Based on his assessment, the adjudicator selected the most accurate segmentation set as the final ground truth. If needed, he would make any necessary modification until a satisfactory ground truth was established for the study. The results output by algorithm were compared with the reference standard, the value of Dice coefficient were shown in the table below: | Application | Algorithm | Average Dice | |------------------------|--------------------------|-----------------| | Coronary Artery | Vessels segmentation | 0.920 | | | Heart segmentation | 0.980 | | Head and Neck Vessel | Head vessel segmentation | 0.902 | | | Neck vessel segmentation | 0.967 | | Aorta | Trunk segmentation | 0.946 | | | Branches segmentation | 0.846 | | Pulmonary Artery | Arteries segmentation | 0.953 | | | Veins segmentation | 0.933 | | Lower Extremity Artery | Arteries segmentation | 0.892 | The subgroups analysis was conducted based on gender, age, i…