(232 days)
Yes
The "Summary of Performance Studies" explicitly states that "Three algorithms based on ML/AI method were tested". Additionally, the descriptions of the training and test sets for the Spine labeling, Rib labeling, and TAVR analysis algorithms further support the use of ML/AI.
No
The device is described as software for viewing, manipulating, evaluating, and analyzing medical images and providing tools for various analyses (e.g., colon, lung nodule, vessel, heart, liver). Its intended use is diagnostic, providing information for interpretation and evaluation, not directly treating a condition or restoring function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is for "viewing, manipulating, evaluating and analyzing medical images" to "support interpretation and evaluation of examinations within healthcare institutions." This directly implies its use in diagnosing medical conditions by aiding in the analysis of patient data. Many of the specific applications listed, such as "CT Lung Nodule application" and "CT Heart application," are clearly designed to help identify and characterize medical conditions.
Yes
The device description explicitly states that uOmnispace.CT is a "post-processing software based on the uOmnispace platform". It does not mention any associated hardware components that are part of the medical device itself. While it processes images from CT scanners (hardware), the device being cleared is the software for viewing, manipulating, evaluating, and analyzing those images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for "viewing, manipulating, evaluating and analyzing medical images" and supports "interpretation and evaluation of examinations within healthcare institutions." This is characteristic of medical image analysis software used for diagnostic purposes based on imaging data, not on in vitro samples (like blood, urine, or tissue).
- Device Description: The description reinforces that it's "post-processing software... for viewing, manipulating, evaluating and analyzing medical images."
- Input Modality: The input modality is CT, which is an imaging technique, not an in vitro test.
- Anatomical Sites: The listed anatomical sites are all parts of the human body being imaged, not samples being analyzed in a lab.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device operates on medical images, which are generated from the body but are not biological samples themselves.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additions:
-The uOmnispace. CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
-The uOmnispace. CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
-The uOmnispace. 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 uOmnispace.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 uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, and evaluating CT vascular images.
-The uOmnispace. CT Brain Perfusion 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 brain.
-The uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
-The uOmnispace. CT Calcium Scoring application is intended to identify calcifications and calculate the calcium soore.
-The uOmnispace. CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes.
-The uOmnispace.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 uOmnispace. CT Liver Evaluation application is intended to 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.
-The uOmnispace. CT Dual Energy is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The u0mnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum.
-The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of head-neck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
The uOmnispace.CT is a post-processing software based on the uOmnispace platform for viewing, manipulating, evaluating and analyzing medical images, can run alone or with other advanced commercially cleared applications.
uOmnispace.CT contains the following applications:
- uOmnispace.CT Calcium Scoring
- uOmnispace.CT Lung Nodule
- uOmnispace.CT Colon Analysis
- uOmnispace.CT Lung Density Analysis
- uOmnispace.CT Dental Application
- uOmnispace.CT Bone Structure Analysis
- uOmnispace.CT Dual Energy
- uOmnispace.CT Vessel Analysis
- uOmnispace.CT Heart
- uOmnispace.CT Brain Perfusion
- uOmnispace.CT Dynamic Analysis
- uOmnispace.CT Liver Evaluation
- uOmnispace.CT Cardiovascular Combined Analysis
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
Colon, Jaw, Lung, Thorax, Vessel, Brain, Heart, Ribs, Spine, Liver, Head-neck, Abdomen, Multi-body part.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare institutions, doctors
Description of the training set, sample size, data source, and annotation protocol
Spine labeling Algorithm:
The training data used for the training of the spine labeling algorithm is independent of the data used to test the algorithm.
Rib labeling Algorithm:
The training data used for the training of the rib labeling algorithm is independent of the data used to test the algorithm.
TAVR analysis algorithm:
The training data used for the training of the post-processing algorithm is independent of the data used to test the algorithm.
Description of the test set, sample size, data source, and annotation protocol
Spine labeling Algorithm:
Performance testing for deep learning-based spine labeling algorithm was performed on 120 subjects.
CT data were acquired from five major manufacturers (GE, Phillips, Siemens, Toshiba, UIH), and with tube voltage of 80 - 140kVp, slice thickness of 0.625-3.75 mm.
Subgroup information:
- Ethnicity: U.S. (90), Asia (30)
- Age: [22, 25] (4), [26, 40] (11), [41, 60] (25), [61, 75] (52), [76, 100] (9), Unknown (18)
- Gender: Female (63), Male (50), Unknown (7)
- BMI (kg/m(2)): =25 (37), Unknown (58)
For ground truth annotations, all ground truth are annotated by well-trained annotators. The annotators use an interactive tool to observe the image, and then set annotation points near the center of vertebral body and assign anatomical labels. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.
Rib labeling Algorithm:
Performance testing for deep learning-based rib labeling algorithm was performed on 120 subjects.
CT data were acquired from five major manufacturers (GE, Phillips, Siemens, Toshiba, UIH), and with tube voltage of 80 - 140kVp, slice thickness of 0.625-3.75 mm.
Subgroup information:
- Ethnicity: U.S. (80), Asia (40)
- Age: [22, 25] (4), [26, 40] (14), [41, 60] (25), [61, 75] (46), [76, 100] (18), Unknown (13)
- Gender: Female (54), Male (66)
- BMI (kg/m(2)): =25 (36), Unknown (51)
For ground truth annotations, all ground truth are annotated by well-trained annotators. A threshold based interactive tool is used to generate initial rib mask, then annotators will refine the rib mask and assign anatomical labels. After the first round annotation, they will check each other's annotation. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.
TAVR analysis algorithm:
Performance testing for the AI-based TAVR analysis algorithm was performed on 60 subjects.
Subgroup information:
- Sex: Male (29), Female (21), Unknown (10)
- Age: [40, 60) (9), [60, 70) (16), [70, 80) (14), [80, 100) (11), Unknown (10)
- Ethnicity: Asia (25), U.S. (35)
- US. Facility: U.S. Facility 1 (25), U.S. Facility 2 (10)
For ground truth annotations, all ground truth are annotated by well-trained annotators. After the first round of annotation, they will check each other's annotation. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Spine labeling Algorithm:
Study Type: Performance testing for deep learning-based spine labeling algorithm.
Sample Size: 120 subjects.
Acceptance Criteria: The average score of the proposed device results is higher than 4 points.
Key Results: The average score of the proposed device results to be validated is 5 points, which is greater than 4 points. Subgroup analysis shows good generalization in different subgroups.
Rib labeling Algorithm:
Study Type: Performance testing for deep learning-based rib labeling algorithm.
Sample Size: 120 subjects.
Acceptance Criteria: The average score of the proposed device results is higher than 4 points.
Key Results: The average score of the proposed device results to be validated is 5 points, which is greater than 4 points. Subgroup analysis shows good generalization in different subgroups.
TAVR analysis algorithm:
Study Type: Performance testing for the AI-based TAVR analysis algorithm.
Sample Size: 60 subjects.
Acceptance Criteria:
- The mean landmark error between the proposed device results and ground truth is less than the threshold, 1 mm.
- The average score of the evaluation criteria is higher than 2.
Key Results: The Mean Landmark Error for all data is 0.86 mm, which is less than 1mm. The average scores of two MD with the American Board of Radiology Qualification on the testing data set is 3, which is higher than 2. Subgroup analysis shows consistent performance across different subgroups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Spine labeling algorithm: Average Score based on ground truth, all data: 5.0.
Rib labeling algorithm: Average Score based on ground truth, all data: 5.0.
TAVR analysis algorithm: Mean Landmark Error (mm) for all data: 0.86; Average Score for all data: 3.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K230162, K230039, K170221, K133643, K182130
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai United Imaging Healthcare Co., Ltd. Xin Gao Official Correspondent No.2258 Chengbei Rd. Jiading District Shanghai, Shanghai 201807 China
Re: K233209
Trade/Device Name: uOmnispace.CT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: April 12, 2024 Received: April 12, 2024
May 17, 2024
Dear Xin Gao:
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" (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).
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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.
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-regulatoryassistance/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, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233209
Device Name uOmnispace.CT
Indications for Use (Describe)
uOmnispace. CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additions: -The uOmnispace. CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon. -The uOmnispace. CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. -The uOmnispace. 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 uOmnispace.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 uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, and evaluating CT vascular images. -The uOmnispace. CT Brain Perfusion 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 brain. -The uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function. -The uOmnispace. CT Calcium Scoring application is intended to identify calcifications and calculate the calcium soore. -The uOmnispace. CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes. -The uOmnispace.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 uOmnispace. CT Liver Evaluation application is intended to 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.
-The uOmnispace. CT Dual Energy is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The u0mnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum.
-The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of head-neck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern.
510 (k) SUMMARY K233209
-
- Date of Preparation: May 16, 2024
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Establishment Registration Number: 3011015597
Contact Person: Xin GAO Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uOmnispace.CT Common Name: Medical image management and processing system Model: uOmnispace.CT
Regulatory Information Classification Name: Medical image management and processing system Classification: II
Product Code: QIH Regulation Number: 21 CFR 892.2050 Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K183170 Common Name: Medical image management and processing system Model: uWS-CT
Regulatory Information
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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern in design.
Classification Name: Medical image management and processing system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology
Reference Device#1 510(k) Number: K230162 Device Name: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
Reference Device#2 510(k) Number: K230039 Device Name: uOmnispace
Reference Device#3 510(k) Number: K170221 Device Name: syngo.CT Cardiac Planning
Reference Device#4 510(k) Number: K133643 Device Name: syngo.CT Liver Analysis
Reference Device#5 510(k) Number: K182130 Device Name: iSchema View's RAPID
5. Device Description
The uOmnispace.CT is a post-processing software based on the uOmnispace platform for viewing, manipulating, evaluating and analyzing medical images, can run alone or with other advanced commercially cleared applications.
uOmnispace.CT contains the following applications:
- uOmnispace.CT Calcium Scoring ●
- uOmnispace.CT Lung Nodule ●
- uOmnispace.CT Colon Analysis
- . uOmnispace.CT Lung Density Analysis
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern in design.
- uOmnispace.CT Dental Application ●
- . uOmnispace.CT Bone Structure Analysis
- uOmnispace.CT Dual Energy
- . uOmnispace.CT Vessel Analysis
- uOmnispace.CT Heart
- . uOmnispace.CT Brain Perfusion
- uOmnispace.CT Dynamic Analysis
- . uOmnispace.CT Liver Evaluation
- . uOmnispace.CT Cardiovascular Combined Analysis
6. Indications for use
uOmnispace.CT is a software for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
- . The uOmnispace.CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
- . The uOmnispace.CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
- . The uOmnispace.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 uOmnispace.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 uOmnispace.CT Vessel Analysis application is intended to provide a tool for viewing, manipulating, and evaluating CT vascular images.
- . The uOmnispace.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 brain.
- . The uOmnispace.CT Heart application is intended to segment heart and extract coronary artery. It also provides analysis of vascular stenosis, plaque and heart function.
- . The uOmnispace.CT Calcium Scoring application is intended to identify calcifications and calculate the calcium score.
- . The uOmnispace.CT Dynamic Analysis application is intended to support visualization of the CT datasets over time with the 3D/4D display modes.
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Image /page/7/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, also in a bold, sans-serif font, with a vertical line running through the center.
- The uOmnispace.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 uOmnispace.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.
- . The uOmnispace.CT Dual Energy is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The uOmnispace.CT Dual Energy application is intended to provide information on the chemical composition of the scanned body materials and/or contrast agents. Additionally, it enables images to be generated at multiple energies within the available spectrum.
- . The uOmnispace.CT Cardiovascular Combined Analysis is an image analysis software package for evaluating contrast enhanced CT images. The CT Cardiovascular Combined Analysis is intended to analyze vascular and cardiac structures. It can be used in the qualitative and quantitative for the analysis of headneck, abdomen, multi-body part combined, TAVR (Transcatheter Aortic Valve Replacement) CT data as input for the planning of cardiovascular procedures.
Summary of Technological Characteristics 7.
The technology characteristics of uOmnispace.CT, reflected in this 510(k) submission are substantially equivalent to those of the predicate devices.
The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uOmnispace.CT when compared to the predicate devices.
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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized icon that resembles the letter "U" with a vertical line running through the center, creating a negative space "I" shape. The icon is a solid color, providing a visual contrast to the white background.
| Item | Proposed Device
uOmnispace.CT | Predicate Device
uWS-CT(K183170) | Remark |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Intended Use | uOmnispace.CT is a software for viewing,
manipulating, evaluating and analyzing medical
images. It supports interpretation and evaluation of
examinations within healthcare institutions. It has
the following additional indications:
The uOmnispace.CT Colon Analysis
application is intended to provide the user a tool to
enable easy visualization and efficient evaluation of
CT volume data sets of the colon. The uOmnispace.CT Dental application is
intended to provide the user a tool to reconstruct
panoramic and paraxial views of jaw. The uOmnispace.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 uOmnispace.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 uOmnispace.CT Vessel Analysis
application is intended to provide a tool for viewing,
manipulating, and evaluating CT vascular images. The uOmnispace.CT Brain Perfusion
application is intended to calculate the parameters | 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 Colon Analysis application is
intended to provide the user a tool to 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 Density application is
intended to provide the user a number of density
parameters and structure information for evaluating
tomogram scans of the lung. 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 CT Brain Perfusion application is
intended to calculate the parameters such as: CBV,
CBF, etc. in order to analyze functional blood flow | Substantial Equivalence.
The proposed device
includes more
applications, which are
discussed in the following
sections, than the predicate
device. This difference
will not impact the safety
and effectiveness of the
device. |
| Item | Proposed Device
uOmnispace.CT | Predicate Device
uWS-CT(K183170) | Remark |
| | such as: CBV, CBF, etc. in order to analyze
functional blood flow information about a region of
interest (ROI) in brain. | information about a region of interest (ROI) in the
brain. | |
| | • The uOmnispace.CT Heart application is
intended to segment heart and extract coronary
artery. It also provides analysis of vascular stenosis,
plaque and heart function. | • The CT Heart application is intended to
segment heart and extract coronary artery. It also
provides analysis of vascular stenosis, plaque and
heart function. | |
| | • The uOmnispace.CT Calcium Scoring
application is intended to identify calcifications and
calculate the calcium score. | • The CT Calcium Scoring application is
intended to identify calcifications and calculate the
calcium score. | |
| | • The uOmnispace.CT Dynamic Analysis
application is intended to support visualization of the
CT datasets over time with the 3D/4D display
modes. | • The CT Dynamic Analysis application is
intended to support visualization of the CT datasets
over time with the 3D/4D display modes. | |
| | • The uOmnispace.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 Bone Structure Analysis application
is intended to provide visualization and labels for the
ribs and spine, and support batch function for
intervertebral disk. | |
| | • The uOmnispace.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. | • 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. | |
| | • The uOmnispace.CT Dual Energy Analysis
is a post-processing software package that accepts
UIH CT images acquired using different tube
voltages and/or tube currents of the same anatomical
location. The uOmnispace.CT Dual Energy
application is intended to provide information on the
chemical composition of the scanned body materials
and/or contrast agents. Additionally it enables | | |
| Item | Proposed Device
uOmnispace.CT | Predicate Device
uWS-CT(K183170) | Remark |
| | images to be generated at multiple energies within
the available spectrum.
• The uOmnispace.CT Cardiovascular
Combined Analysis is an image analysis software
package for evaluating contrast enhanced CT
images. The CT Cardiovascular Combined Analysis
is intended to analyze vascular and cardiac
structures.It can be used in the qualitative and
quantitative for the analysis of head-neck, abdomen,
multi-body part combined, TAVR (Transcatheter
Aortic Valve Replacement) CT data as input for the
planning of cardiovascular procedures. | | |
9
Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark blue with a white horizontal line through the middle. The logo is simple and modern.
10
Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized, dark blue icon that resembles the letter "U" with a horizontal line through the middle, creating a shape that also resembles the letter "I".
11
Image /page/11/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is divided into three sections by two vertical white lines. The logo is simple and modern, and the use of bold font and geometric shapes gives it a strong visual impact.
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT(K183170) | Remark |
|----------------------------------------|------------------------------------|----------------------------------|--------------------------------------|--------|
| uOmnispace.CT Lung
Density Analysis | Lung Segmentation | Yes | Yes | Same |
| | Lung Density Analysis | Yes | Yes | Same |
| | Lung Contour Editing | Yes | Yes | Same |
| | Pulmonary lobes Segmentation | Yes | Yes | Same |
| | Airway Segmentation | Yes | Yes | Same |
| | Airway Tree Extraction and Editing | Yes | Yes | Same |
| | Airway Contour Editing | Yes | Yes | Same |
| | Statistical Analysis | Yes | Yes | Same |
| | Save, Report, Print | Yes | Yes | Same |
12
Image /page/12/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue with a white vertical line running through the center. The logo is simple and modern in design.
| Application | Function Name | Proposed Device
uOmnisapce.CT | Predicate
Device:
uWS-CT
(K183170) | Reference Device#5
iSchema View's RAPID
(K182130) | Remark |
|----------------------------------|-----------------------------------|----------------------------------|---------------------------------------------|---------------------------------------------------------|------------------------------------------------|
| uOmnispace.CT
Brain Perfusion | Motion Correction | Yes | Yes | / | Same |
| | Arterial Detection | Yes | Yes | / | Same |
| | Parameter Map
Calculation | Yes | Yes | / | Same |
| | Time-density curve
analysis | Yes | Yes | / | Same |
| | Tmax | Yes | / | Yes | Functional Substantial
Equivalent
Note 1 |
| | Ischemic penumbra
analysis | Yes | / | Yes | Functional Substantial
Equivalent
Note 2 |
| | Symmetric ROI and
ROI Template | Yes | Yes | / | Same |
| | Save, Report, Print | Yes | Yes | / | Same |
13
Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is also in a bold font. The color of the logo is a dark gray.
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT
(K183170) | Reference
device#2
UOmnispace
(K230039) | Remark |
|-------------------------|-----------------------------|----------------------------------|------------------------------------------|--------------------------------------------------|------------------------------------------------|
| uOmnispace.
CT Heart | Multi-Phase Loading | Yes | Yes | / | Same |
| | Hyper Realistic Rendering | Yes | / | Yes | Same |
| | Heart Chamber Segmentation | Yes | Yes | / | Same |
| | Coronary Artery Extraction | Yes | Yes | / | Same |
| | Editing Tools | Yes | Yes | / | Same |
| | Centerline Extraction | Yes | Yes | / | Same |
| | Stenosis Analysis | Yes | Yes | / | Same |
| | Plaque Analysis | Yes | Yes | / | Same |
| | Cardiac function Assessment | Yes | Yes | / | Functional Substantial
Equivalent
Note 3 |
| | Save, Report, Print | Yes | Yes | / | Same |
| Application | Function name | Proposed device uOmnispace.CT | Predicate device: uWS-CT(K183170) | Remark |
|---|---|---|---|---|
| uOmnispace.CT | ||||
| Calcium Scoring | Calcium sites segmentation | Yes | Yes | Same |
| Calculate Calcium score | Yes | Yes | Functional Substantially | |
| Equivalent | ||||
| Note 4 | ||||
| Save, Report, Print | Yes | Yes | Same |
14
Image /page/14/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized icon that resembles a shield or a letter "U" with a vertical line running through the center. The logo is simple and modern in design.
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT(K183170) | Remark |
|------------------------------------------|-----------------------------------|----------------------------------|---------------------------------------|---------------------------------------------|
| uOmnispace.CT Bone
Structure Analysis | Labeling Ribs | Yes | Yes | Functional Substantial Equivalent
Note 5 |
| uOmnispace.CT Bone
Structure Analysis | Labeling Spine | Yes | Yes | Functional Substantial Equivalent
Note 6 |
| uOmnispace.CT Bone
Structure Analysis | Batch | Yes | Yes | Same |
| uOmnispace.CT Bone
Structure Analysis | Save, Report, Print | Yes | Yes | Same |
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT (K183170) | Remark |
| uOmnispace.CT
Dynamic Analysis | Motion correction | Yes | Yes | Same |
| uOmnispace.CT
Dynamic Analysis | Multiple phase viewing | Yes | Yes | Same |
| uOmnispace.CT
Dynamic Analysis | Bone Removal | Yes | Yes | Same |
| uOmnispace.CT
Dynamic Analysis | Data Loading and 3D/4D
Display | Yes | Yes | Same |
| uOmnispace.CT
Dynamic Analysis | Artery and Vein Display | Yes | Yes | Same |
| uOmnispace.CT
Dynamic Analysis | Save, Report, Print | Yes | Yes | Same |
15
Image /page/15/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the logo is a dark teal.
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device
uWS-CT
(K183170) | Reference device#3
uOmnispace
(K230039) | Reference
device#4
syngo.CT
Liver Analysis
(K133643) | Remark |
|-----------------------------------|----------------------------------------------------------|----------------------------------|-----------------------------------------|-----------------------------------------------|------------------------------------------------------------------|------------------------------------------------|
| uOmnispace.CT
Liver Evaluation | Phase Selection | Yes | Yes | / | / | Same |
| | Liver Segmentation | Yes | Yes | / | / | Same |
| | Lesion Segmentation | Yes | Yes | / | / | Same |
| | Rib Segmentation
and
manual correction | Yes | / | Yes | / | Same |
| | Vessel Extraction | Yes | Yes | / | / | Same |
| | Vascular Editing | Yes | Yes | / | / | Same |
| | Liver Segments | Yes | Yes | / | / | Same |
| | Virtual Planning | Yes | Yes | / | / | Same |
| | RFA | Yes | Yes | / | / | Same |
| | Vascular Territories
Computation and
visualization | Yes | / | / | Yes | Functional Substantial
Equivalent
Note 7 |
| | Measurement | Yes | Yes | / | / | Same |
| | Save, Report, Print | Yes | Yes | / | / | Same |
16
Image /page/16/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized logo that resembles a shield or a letter 'U' with a vertical line running through the center, creating a negative space 'I' shape.
| Application | Function name | Proposed device
uOmnispace.CT | Reference Device#1:
uCT 760 with uWS-CT-Dual
Energy Analysis, uCT 780
with uWS-CT-Dual Energy
Analysis (K230162) | Remark |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| uOmnispace.CT
Dual
Energy | Mono Energetic Image | Yes | Yes | Same |
| | Mixed Enhanced Image | Yes | Yes | Same |
| | CNR(Contrast Noise Ratio) Image | Yes | Yes | Same |
| | Base Material Images: Including
Water-Iodine, Water-Calcium,
Calcium-Iodine, Uric acid-Calcium,
Water-HAP, Liver-Fat Base
Material Pair image. | Yes | Yes | Functional Substantially
Equivalent
Note 8 |
| | Image Registration | Yes | Yes | Same |
| | Effective Atomic Number Images
• Component analysis of
kidney stones, uric acid stones or
non-uric acid stones
• Component analysis of
joint gout, uric acid gout or non-
uric acid gout | Yes | Yes | Functional Substantial
Equivalent
Note 9 |
| | Electron Density Images | Yes | Yes | Same |
| | Virtual Non contrast Images | Yes | Yes | Same |
| | Save. Report, Print | Yes | Yes | Same |
17
Image /page/17/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized icon that resembles a shield or a letter "U" with a vertical line running through the center. The logo is simple and modern in design.
| Application | Function name | Proposed Device
uOmnispace.CT | Predicate Device:
uWS-CT(K183170) | Remark |
|-------------------------------------|---------------------------------------------|----------------------------------|--------------------------------------|-------------------------------------------------|
| uOmnispace.CT Dental
Application | Defining the Reference Plane | Yes | Yes | Same |
| | Plotting Panoramic Curve | Yes | Yes | Same |
| | Marking the Nerve Canals | Yes | Yes | Same |
| | Cross Sectional Operations | Yes | Yes | Same |
| | Dental VRT Display | Yes | Yes | Same |
| | Save, Report, Print (True size
printing) | Yes | Yes | Functional Substantial
Equivalent
Note 10 |
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT(K183170) | Remark |
|---------------------------------|--------------------------------------------------|----------------------------------|--------------------------------------|--------|
| uOmnispace.CT Colon
Analysis | Colon Segmentation and
Centerline Calculate | Yes | Yes | Same |
| | Electronic Colon Cleansing | Yes | Yes | Same |
| | Manual Polyps Marking | Yes | Yes | Same |
| | Colon editing and Center Line
editing | Yes | Yes | Same |
| | Polyps' Quantitative
Calculation and Analysis | Yes | Yes | Same |
| | Virtual Endoscopy | Yes | Yes | Same |
| | Save, Report, Print | Yes | Yes | Same |
18
Image /page/18/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, dark teal font. To the right of the words is a stylized teal symbol that resembles a shield with a white line running vertically through the center.
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT(K183170) | Reference device#3
uOmnispace
(K230039) | Remark |
|----------------------------------|--------------------------------------------------------|----------------------------------|--------------------------------------|-----------------------------------------------|--------|
| uOmnispace.CT Vessel
Analysis | Bone removal | Yes | Yes | / | Same |
| | Vessel and centerlines
Extraction | Yes | Yes | / | Same |
| | Semi-automatic vessel
extraction | Yes | Yes | / | Same |
| | Vascular Measurement and
vascular stenosis analysis | Yes | Yes | / | Same |
| | Save, Report, Print | Yes | Yes | / | Same |
| | Hyper Realistic Rendering | Yes | / | Yes | Same |
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT(K183170) | Remark | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------|-------------------------------------------------|--------------------------------------------------|
| uOmnispace.CT Lung
Nodule | Marking Nodules | Yes | Yes | Same | |
| | Follow-up Analysis | Yes | Yes | Same | |
| | Lung Segmentation | Yes | Yes | Same | |
| | Nodule Segmentation | Yes | Yes | Same | |
| | Measurement for the
segmented nodule | Yes | Yes | Same | |
| | Save, Report, Print | Yes | Yes | Same | |
| Application | Function name | Proposed device
uOmnispace.CT | Predicate device:
uWS-CT
(K183170) | Reference
device#3
Syngo.via
(K170221) | Remark |
| uOmnispace.CT
Cardiovascular
Combined
Analysis | Vessel analysis:
● Bone removal
● Vessel and centerlines Extraction
● Semi-automatic vessel extraction
● Vascular Measurement and vascular -stenosis analysis
● Hyper Realistic Rendering | Yes | Yes | / | Functional Substantial
Equivalent
Note 11. |
| | Heart Analysis:
● Multi-Phase Loading
● Hyper Realistic Rendering
● Heart Chamber Segmentation
● Coronary Artery Extraction
● Editing Tools
● Centerline Extraction
● Stenosis Analysis
● Plaque Analysis
● Cardiac function Assessment | Yes | Yes | / | Functional Substantial
Equivalent
Note 12. |
| | Fusion Review:
● The Combined Display of Heart and Vessels tissue | Yes | Yes | / | Same |
| TAVR Evaluation :
• Automatic Aortic
annulus location and manually
correction
• Automatic Coronary
ostia Location and manually
correction
• Multi-parameter
Calculation | Yes | / | Yes | Functional Substantial
Equivalent
Note 13 | |
| Save, Report, Print | Yes | Yes | / | Same | |
19
Image /page/19/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark blue. The logo is simple and modern.
20
Image /page/20/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized icon that resembles a shield with a vertical line running through the center. The logo is simple and modern in design.
Note 1:
Compared to reference device, the parameter principle and the functional implementation mode of Thax is consistent with RAPID. Additional verification tests were carried out to demonstrate that uOmissace. T vields acurate quantitative perfusion parameters. Therefore, this technological difference does not raise new issues of safety and effectiveness as compared to RAPID.
Note 2:
Compared to reference device, the function in Penumbra Analysis is consistent with RAPID. Additional verification tests were carried out to demonstrate that uOmnispace. Therefore parameters. Therefore, this technological difference does not raise new issues of safety and effectiveness as compared to RAPID.
Note 3:
Compared to predicate device add the calculation of parameters related to the left and right atria. These calculation is similar to the calculation of registered ventricular parameters. This difference between the predicate device doesn't impact the safety and effectiveness of the proposed device.
Note 4:
Compared to predicate device, the proposed device adds the computed Agatston Score to cited literature called Distribution of Coronary Artery Calcium by Race, Gender, and Age. The added function supports to compare the CAC between the normal people based on MESA database. The operating principle and the same, this difference between the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.
21
Image /page/21/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized, dark teal-colored icon that resembles a shield or a stylized letter 'U' with a vertical line running through the center.
Note 5:
Compared to predicate device, the proposed device optimizes a new algorithm based on deep learning. This algorithm supports the same function as uWS-CT (K183170). This difference between the predicate device doesn't impact the safety and effectiveness of the proposed device.
Note 6:
Compared to predicate device, the proposed device optimizes a new algorithm based on deep learning. This algorithm supports the same function as uWS-CT (K183170). This difference between the predicate device doesn't impact the safety and effectiveness of the proposed device.
Note 7:
Compared to predicate device, the proposed device scomputation and visualization based on vessel branches. The operating principle and the scientific technology are the same. There would be no clinically significant difference in the proposed device.
Note 8:
Compared to predicate device, the proposed device supports the generation of more base material pains. There is no change in algorithm and this algorithm support the same finction as K230162. This difference between the proposed device doesn't impact the safety and effectiveness of the proposed device.
Note 9:
Compared to prodicate device, the proposed device increased the volume calculation based on the effective Atomic Number Image, the volume calculation is the process of pixel counting. There is no change in algorithm support the same function as K230162. This difference between the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.
Note 10:
Compared to predicate device adds twe size printing, there is no change in operating principle and it is only through the ratio of the printed image scale to the real physical scale. The print effect is obtained. This difference between the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.
22
Image /page/22/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized symbol that resembles a shield or a letter 'U' with a vertical line running through the center, creating a negative space 'I' shape. The logo is simple and modern in design.
Note 11:
For uOmnispace.CT Cardiovascular Combined Analysis application, it integrates uOmnispace.CT Vessel Analysis application and uOmnispace.CT Heart application, these two applications are the CT Vessel Analysis application and the CT Heart application in K183170. There would be no impact on safety and effectiveness of this function.
Note 12:
The function of cardiac analysis refer to uOmnispace.CT Heart.
For u0mnispace.CT Cardiovascular Combined Analysis application, it integrates uOmnispace.CT Vessel Analysis application and uOmnispace.CT Heart application, these two applications are the CT Vessel Analysis application and the CT Heart application in K183170. There would be no impact on safety and effectiveness of this function.
Note 13:
For uOmnispace.CT Cardiovascular Combined Analysis application is substantively equivalent to the predicate device Syngo. via (K17022). Additionally, the proposed device can provide the left and right coronary ostium to annulus. Testing was performed to ensure the measurements meet the predetermined acceptance values the proposed device and the reference device doesn't impact the safety and effectiveness of the proposed device.
23
Image /page/23/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided into two halves by a vertical white line. The logo is simple and modern, with a focus on the company name and a unique visual element.
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 the Basic Documentation Level, including:
- · Software Description
- · Device Hazard Analysis
- · Software Requirements Specification (SRS)
- · Software Architecture Design Chart
- · Software Development Environment Description
- Software Verification and Validation
- · Cybersecurity Documents
Animal Study
No animal study was required.
Clinical Studies
No clinical study was required.
Performance Verification
There are three algorithms based on ML/AI method:
-
Spine labeling algorithm
-
Rib labeling algorithm
-
TAVR analysis algorithm
More information about the ML/AI algorithm is as follows:
1. Spine labeling Algorithm
The performance testing for deep learning-based spine labeling algorithm was performed on 120 subjects (data shown in Table 8-2) during the product development.
Acceptance Criteria ●
The validation type and acceptance criteria is shown in the Table 8-1 below:
24
Image /page/24/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The "U" shape has a vertical line running through the center and a horizontal line across the top, creating a cross-like shape within the "U".
| Table 8-1. Validation type and acceptance criteria | ||
|---|---|---|
| Validation Type | Acceptance Criteria |
|---|---|
| Score based on ground truth | The average score of the proposed device |
| results is higher than 4 points. |
. Testing Data Information
Equipment and Protocols 1)
CT data were acquired from five major manufacturers (GE, Phillips, Siemens, Toshiba, UIH), and with tube voltage of 80 - 140kVp, slice thickness of 0.625-3.75 mm.
Clinical Subgroup Information 2)
The subgroup information of testing data is summarized below.
| Subgroup | Details of Each Subgroup | Sample Size |
|---|---|---|
| Ethnicity | U.S. | 90 |
| Asia | 30 | |
| Age | [22, 25] | 4 |
| [26, 40] | 11 | |
| [41, 60] | 25 | |
| [61, 75] | 52 | |
| [76, 100] | 9 | |
| Unknown | 18 | |
| Gender | Female | |
| Male | 63 | |
| Unknown | 7 | |
| BMI (kg/m(2)) | =25 | 37 |
| Unknown | 58 |
Table 8-2. Testing data subgroup information
. Performance Testing Summary
The average score of the proposed device results to be validated is 5 points, which is greater than 4 points. Meanwhile, the subgroup analysis shows that (Table 8-3) the proposed device algorithm has good generalization in different subgroups.
| Table 6-3. Subgroup performance test | |
|---|---|
| Ethnicity | Average Score of All Test Dataset |
| U.S. | 5.0 |
| Asia | 5.0 |
| Age | Average Score of All Test Dataset |
| [22, 25] | 5.0 |
| [26, 40] | 5.0 |
| [41, 60] | 5.0 |
| [61,75] | 5.0 |
| [76, 100] | 5.0 |
| Unknown | 5.0 |
| Gender | Average Score of All Test Dataset |
| Female | 5.0 |
| Male | 5.0 |
| Unknown | 5.0 |
Table 8-3. Subgroup performance test
25
Image /page/25/Picture/1 description: The image shows the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark blue. The logo is simple and modern.
| BMI (kg/m(2)) | Average Score of All Test Dataset |
|---|---|
| =25 | 5.0 |
| Unknown | 5.0 |
. Standard Annotation Process
For ground truth annotations, all ground truth are annotated by well-trained annotators.
The annotators use an interactive tool to observe the image, and then set annotation points near the center of vertebral body and assign anatomical labels. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.
. Testing & Training Data Independence
The training data used for the training of the spine labeling algorithm is independent of the data used to test the algorithm.
2. Rib labeling Algorithm
The performance testing for deep learning-based rib labeling algorithm was performed on 120 subjects (data shown in Table 8-5) during the product development.
. Acceptance Criteria
The validation type and acceptance criteria is shown in the Table 8-4 below:
| Validation Type | Acceptance Criteria |
|---|---|
| Score based on ground truth | The average score of the proposed device |
| results is higher than 4 points. |
Table 8-4. Validation type and acceptance criteria
. Testing Data Information
Equipment and Protocols 1)
CT data were acquired from five major manufacturers (GE, Phillips, Siemens, Toshiba, UIH), and with tube voltage of 80 - 140kVp, slice thickness of 0.625-3.75 mm.
2) Clinical Subgroup Information
The subgroup information of testing data is summarized below.
| Table 8-5. Testing data subgroup information | ||
|---|---|---|
| Subgroup | Details of each subgroup | Sample Size |
| Ethnicity | U.S. | 80 |
| Asia | 40 | |
| Age | [22, 25] | 4 |
| [26, 40] | 14 | |
| [41, 60] | 25 | |
| [61, 75] | 46 | |
| [76, 100] | 18 | |
| Unknown | 13 |
26
Image /page/26/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED" and "IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.
| Gender | Female | 54 |
|---|---|---|
| Male | 66 | |
| BMI (kg/m(2)) | =25 | 36 |
| Unknown | 51 |
. Performance Testing Summary
The average score of the proposed device results to be validated is 5 points, which is greater than 4 points. Meanwhile, the subgroup analysis shows that (Table 8-6) the proposed device algorithm has good generalization in different subgroups.
| Ethnicity | Average Score of All Test Dataset |
|---|---|
| U.S. | 5.0 |
| Asia | 5.0 |
| Age | Average Score of All Test Dataset |
| [22, 25] | 5.0 |
| [26, 40] | 5.0 |
| [41, 60] | 5.0 |
| [61, 75] | 5.0 |
| [76, 100] | 5.0 |
| Unknown | 5.0 |
| Gender | Average Score of All Test Dataset |
| Female | 5.0 |
| Male | 5.0 |
| BMI (kg/m(2)) | Average Score of All Test Dataset |
| =25 | 5.0 |
| Unknown | 5.0 |
Table 8-6. Subgroup performance test
. Standard Annotation Process
For ground truth annotations, all ground truth are annotated by well-trained annotators. A threshold based interactive tool is used to generate initial rib mask, then annotators will refine the rib mask and assign anatomical labels. After the first round annotation, they will check each other's annotation. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.
. Testing & Training Data Independence
The training data used for the training of the rib labeling algorithm is independent of the data used to test the algorithm.
3. TAVR analysis algorithm
The performance testing for the AI-based TAVR analysis algorithm was performed on 60 subjects (data shown in Table 8-8) during the product development.
● Acceptance Criteria
27
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The validation type and acceptance criteria are shown in Table 8-7 below:
| Validation Type | Acceptance Criteria |
|---|---|
| Verify the consistency with ground truth | The mean landmark error between the proposed device results and ground truth is less than the threshold, 1 mm. |
| Subjective Scoring of doctors with U.S. professional qualifications | The average score of the evaluation criteria is higher than 2. |
9 7 Validetion tu and .............................................................................................................................................................................. . .
Testing Data Information .
| Information of data | Details of each subgroup | Sample size |
|---|---|---|
| Sex | Male | 29 |
| Female | 21 | |
| Unknown | 10 | |
| Age | [40, 60) | 9 |
| [60, 70) | 16 | |
| [70, 80) | 14 | |
| [80, 100) | 11 | |
| Unknown | 10 | |
| Ethnicity | Asia | 25 |
| U.S. | 35 | |
| US. Facility | U.S. Facility 1 | 25 |
| U.S. Facility 2 | 10 |
Table 8-8, Testing data information
. Performance Testing Summary:
The Mean Landmark Error for all data is 0.86 mm, which is less than 1mm. The average scores of two MD with the American Board of Radiology Qualification on the testing data set is 3, which is higher than 2. Meanwhile, the subgroup analysis shows that (Table 8-9) the performance of the algorithm consists of different subgroups.
| All | Mean Landmark Error (mm) | Average Score |
|---|---|---|
| All data | 0.86 | 3 |
| Age | Mean Landmark Error (mm) | Average Score |
| [40, 60) | 0.888 | 3 |
| [60, 70) | 0.818 | 3 |
| [70, 80) | 0.907 | 3 |
| [80, 100) | 0.845 | 3 |
| unknown | 0.85 | 3 |
| Gender | Mean Landmark Error (mm) | Average Score |
| Female | 0.9 | 3 |
| Male | 0.834 | 3 |
| Unknown | 0.85 | 3 |
| Ethnicity | Mean Landmark Error (mm) | Average Score |
| Asia | 0.852 | 3 |
| U.S. | 0.866 | 3 |
| US. Facility | Mean Landmark Error (mm) | Average Score |
| U.S. Facility 1 | 0.872 | 3 |
Table 8-9. Subgroup performance test
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| YY N
The States of the Career of the Comments of the Children
0.85
| J.S. Facility | ||
|---|---|---|
| --------------------------------------------------------------------------------------------- | -- | -- |
. Standard Annotation Process
For ground truth annotations, all ground truth are annotated by well-trained annotators. After the first round of annotation, they will check each other's annotation. Finally, all ground truth are evaluated by two licensed physicians with U.S. credentials.
. Testing & Training Data Independence
The training data used for the training of the post-processing algorithm is independent of the data used to test the algorithm.
Other Standards and Guidance
- NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
- ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007).
- . IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015).
Summary
The features described in this premarket submission are supported with the results of the testing mentioned above; the uOmnispace.CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.
9. Substantially Equivalent (SE) Conclusion
The proposed device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics, performance specification, device hazards as well as verification and validation results.
In summary, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device and reference devices.