(263 days)
Not Found
Yes
The document explicitly mentions "DELTA (Deep Recon) algorithm" and describes training and test datasets for this algorithm, which are characteristic of AI/ML development and evaluation.
No
The device is a diagnostic imaging system used to produce images of the body for the purpose of detecting conditions like lung nodules. It does not provide treatment or therapy.
Yes.
The device is a Computed Tomography x-ray system intended to produce cross-sectional images of the body, which are used for diagnostic purposes, including for the early detection of lung nodules that may represent cancer. Additionally, the post-processing software analyzes chemical composition differences to provide further diagnostic information.
No
The device description clearly states that the submission is for a "Computed Tomography X-ray System, uCT 780," which is a hardware device. While it includes a software component (uWS-CT-Dual Energy Analysis), the overall device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The uCT 780 and its associated software are imaging systems. They produce cross-sectional images of the body using X-rays. While these images are used for diagnostic purposes (identifying lung nodules, assessing anatomical structures), they do not involve the analysis of in vitro specimens.
- Intended Use: The intended use clearly describes producing images of the body and using those images for diagnosis and screening. It does not mention analyzing biological samples.
- Device Description: The description focuses on the imaging process and the software's ability to process image data. There is no mention of handling or analyzing biological specimens.
Therefore, the uCT 780 and uWS-CT-Dual Energy Analysis are considered medical imaging devices, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
- Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The Computed Tomography X-ray System, uCT 780, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.
The uWS-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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information. In this submission, the DETLA (Deep Recon) feature of the proposed device is modified and there is no other significant change compared with K230162. The detail comparison of DELTA between the proposed device and the predicate device (K230162) is introduced in the below sections.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography X-ray
Anatomical Site
whole body (including head, neck, cardiac and vascular)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The validation dataset includes 20 cases, with 5 cases for each body part-abdomen, chest, head, and cardiac-scanned at a normal dose and reconstructed using normaldose FBP, as well as simulated low-dose DELTA images. The test dataset includes 40 cases, with 10 cases for each body part-abdomen, chest, head, and cardiac-scanned at various doses and reconstructed using FBP and DELTA.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing for DELTA (Deep Recon) algorithm was performed on the Bench Testing and the Clinical Evaluation.
8.1 Bench Test - Phantom Test
The bench testing is conducted on a variety of phantoms to quantify the improvement of images with DELTA when compared to the Standard Reconstruction Protocol using FBP. Some basic image quality tests were also performed on DELTA to confirm that it meets the diagnostic requirements. The image quality (IQ) of the proposed device was tested through the below evaluation methods:
- General IQ Performance testing of metrics identified in IEC 61223-3-5 to study overall performance in a standardized and referenceable manner. General IQ tests include CT HU number test and thickness section test based on water phantom and Catphan 700 phantom.
- Noise power spectrum test was applied on water phantom for more comprehensive test on DELTA.
- Mean CT value test on CT Whole Body Phantom PBU-60 phantom was applied to comparing mean HU value of different clinical relevant tissue between FBP and DELTA.
- A low contrast detectability (LCD) test was performed to evaluate the LCD enhancement, dose reduction and noise reduction on MITA CCT189 and MITA CCT191 phantom.
- A high contrast spatial resolution test was performed under the guidance of IEC 61223-3-5 to evaluate the high contrast spatial resolution enhanced comparing with FBP.
8.1.3 Bench Testing Results and conclusion
- DELTA passed the basic general IQ test which satisfied the requirement of IEC 61223-3-5.
- Noise power spectrum of DELTA is similar to FBP.
- Mean CT value for different tissues of DELTA is less than 4HU in head and 6HU in body compared with that of FBP.
- DELTA showed better LCD and noise compared with FBP at same scanning dose and can reduce scanning dose compared with FBP at same LCD.
- DELTA showed better spatial resolution compared with FBP at same scanning dose.
In summary, the bench testing result shows that DELTA had better image noise, LCD and spatial resolution at same scanning dose compared with FBP, and DELTA can keep the image quality (LCD) under lower scanning dose compared with FBP.
8.2 Clinical Assessment
8.2.1 Clinical Evaluation Method
The proposed device performed a reader study of sample clinical data as clinical evaluation. The image quality was scored by 2 board-certified U.S. radiologists to perform a five-point scale evaluation of both image sets on three image quality aspects: noise, structure fidelity and overall image quality.
8.2.2 Testing Data Information
The clinical datasets in the evaluation covered different head, chest, abdomen and cardiac protocol, common diseases, different scanning dose and a wide range of population. The datasets were reconstructed with DELTA and FBP. The performance testing for DELTA algorithm was performed on 60 subjects during the product development.
The validation dataset includes 20 cases, with 5 cases for each body part-abdomen, chest, head, and cardiac-scanned at a normal dose and reconstructed using normaldose FBP, as well as simulated low-dose DELTA images.
The test dataset includes 40 cases, with 10 cases for each body part-abdomen, chest, head, and cardiac-scanned at various doses and reconstructed using FBP and DELTA.
8.2.3 Clinical Acceptance Criteria
- The mean score of simulated low dose DELTA image is equal or higher than the mean score of normal dose FBP.
- The mean score of DELTA is better than the mean score of FBP under same dose.
- DELTA can have satisfy diagnosis requirement in all the evaluated image.
8.2.4 Clinical Evaluation Results and Conclusion
- Validation dataset evaluation showed that the DELTA method yielded equivalent or better image quality at lower dose compared with the FBP on them with standard dose.
- Test dataset evaluation showed that DELTA reconstruction method yielded better image quality compared with FBP reconstruction.
- All the study results show that the acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 7, 2025
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd. Jiading District Shanghai, 201807 CHINA
Re: K241079
Trade/Device Name: uCT 780 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 30, 2024 Received: December 6, 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.
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,
Lu Jiang
Lu Jiang, PhD Assistant Director Diagnsotic X-ray Systems 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
Enclosure
3
Indications for Use
Device Name
uCT 780
Indications for Use (Describe)
uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
- Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
uWS-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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
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)
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Image /page/4/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 letter "U" that is split into two halves with a horizontal line in the middle. The logo is a dark gray color and is set against a white background.
510 (K) SUMMARY
K241079
Date of Preparation 1.
January 7, 2025
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Contact Person: Xin GAO Position: Regulatory Affair Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: uCT 780 Model(s): uCT 780, uWS-CT-Dual Energy Analysis Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
Identification of Predicate Device(s) 4.
Predicate Device 510(k) Number: K230162 Trade Name: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis Model(s): uCT 760, uCT 780 Regulation Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750 Regulatory Class: II Product Code: JAK Review Panel: Radiology
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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" stacked on top of each other in a sans-serif font. To the right of the words is a stylized letter "U" that is dark gray. The logo is simple and modern.
Device Description: 5.
The Computed Tomography X-ray System, uCT 780, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.
The uWS-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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. CT dual energy analysis application combines images acquired with low and high energy spectra to visualize this information. In this submission, the DETLA (Deep Recon) feature of the proposed device is modified and there is no other significant change compared with K230162. The detail comparison of DELTA between the proposed device and the predicate device (K230162) is introduced in the below sections.
6. Indications for Use
uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).
uCT 780 is intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. * Please refer to clinical literature, including the results of the National Lung Screening
Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
6
Image /page/6/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is also in a bold, sans-serif font. The logo is a dark gray color.
uWS-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 various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.
7. Substantially Equivalence Discussion
The DELTA (Deep Recon) is an AI-based reconstruction method that deployed within uCT 780 acquisition and processing software. The hardware environment and software platform for the DELTA in the proposed device and the predicate device are same. The indications for use and the scientific technology remain unchanged. The table below summarizes the Technological Characteristics between the proposed and predicate devices.
| | Proposed device
uCT 780 with uWS-CT-Dual
Energy Analysis | Predict device
uCT 760/780 with uWS-
CT-Dual Energy Analysis
(K230162) | Discussion |
|--------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| DELTA
(Deep
Recon) | AI-based deep learning
reconstruction algorithm. | AI-based deep learning
reconstruction algorithm. | Same |
| Applicable
Body Parts | head, chest, abdomen, cardiac and
vascular CT applications for adults | head, chest, abdomen,
cardiac and vascular CT
applications for adults | Same |
| User
Interface | 5 noise reduction levels. | 4 noise reduction levels. | The user interface
increased the choice for the
noise reduction level. This
will not introduce safety or
effectiveness issues. |
| Dataset Size | The new dataset was increased to
127 cases compared with the
original dataset. | Original Dataset | Dataset was increased .to
improve robustness of the
algorithm. The difference
will not introduce safety or
effectiveness issues. |
| Clinical
workflow | Select recon type and strength
(noise index level). | Select recon type and
strength (noise index level). | Same |
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Image /page/7/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is also in a bold font. The logo is simple and modern, and the colors are muted.
| Phantom test | Phantom test for dose
reduction, LCD, noise and
spatial resolution improving
test.
Basic IQ performance test
including HU value on water
phantom, thickness section
test.
Additional HU value test on
tissue-mimicking phantom,
noise spectrum power test. | Phantom test for dose
reduction, LCD, noise
and spatial resolution
improving test.
Basic IQ performance
test including HU value
on water phantom,
thickness section test. | Adding more phantom
tests, including HU value
test on tissue-mimicking
phantom and noise
spectrum power test to give
a more comprehensive tests
results. The difference will
not introduce safety and
effectiveness issues. |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | DELTA is able to generate CT
images at lower dose in the low
dose simulation validation and
generate equivalent or better
image quality compared with FBP
in the clinical scenarios of real
scan under a variety of dose levels. | DELTA is able to generate
CT images with lower image
noise and improve low
contrast detectability and
also to reduce the dose
required for diagnostic CT
imaging. | Substantially Equivalent.
The function of DELTA is
optimized in the proposed
device, which improved the
algorithm framework. The
difference will not
introduce safety and
effectiveness issues. |
8. Performance Testing Information
The performance testing for DELTA (Deep Recon) algorithm was performed on the Bench Testing and the Clinical Evaluation.
8.1 Bench Test - Phantom Test
The bench testing is conducted on a variety of phantoms to quantify the improvement of images with DELTA when compared to the Standard Reconstruction Protocol using FBP. Some basic image quality tests were also performed on DELTA to confirm that it meets the diagnostic requirements. The image quality (IQ) of the proposed device was tested through the below evaluation methods:
8.1.1 Phantom Testing
- . General IQ Performance testing of metrics identified in IEC 61223-3-5 to study overall performance in a standardized and referenceable manner. General IQ tests include CT HU number test and thickness section test based on water phantom and Catphan 700 phantom.
- . Noise power spectrum test was applied on water phantom for more comprehensive test on DELTA.
- . Mean CT value test on CT Whole Body Phantom PBU-60 phantom was applied to comparing mean HU value of different clinical relevant tissue between FBP and DELTA.
- . A low contrast detectability (LCD) test was performed to evaluate the LCD enhancement, dose reduction and noise reduction on MITA CCT189 and MITA CCT191 phantom.
- . A high contrast spatial resolution test was performed under the guidance of IEC 61223-3-5 to evaluate the high contrast spatial resolution enhanced comparing with FBP.
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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 words is a stylized "U" shape, also in bold. The color of the logo is a dark teal.
8.1.2 Study pass criteria
- DELTA should pass the basic IQ test according to IEC 61223-3-5. .
- Noise power spectrum of DELTA should be similar to FBP image. ●
- Mean CT value of DELTA under various tissues should be similar to that of FBP ● and the error should be less than 4HU in head and 6HU in body.
- . Compared with FBP, DELTA should have better LCD and noise under same scanning dose, and DELTA can reduce scanning dose keep similar LCD comparing with FBP.
- . Compared with FBP, DELTA should have better high contrast spatial resolution.
8.1.3 Bench Testing Results and conclusion
- DELTA passed the basic general IQ test which satisfied the requirement of IEC ● 61223-3-5.
- Noise power spectrum of DELTA is similar to FBP. ●
- Mean CT value for different tissues of DELTA is less than 4HU in head and 6HU in body compared with that of FBP
- . DELTA showed better LCD and noise compared with FBP at same scanning dose and can reduce scanning dose compared with FBP at same LCD.
- DELTA showed better spatial resolution compared with FBP at same scanning dose.
In summary, the bench testing result shows that DELTA had better image noise, LCD and spatial resolution at same scanning dose compared with FBP, and DELTA can keep the image quality (LCD) under lower scanning dose compared with FBP.
8.2 Clinical Assessment
8.2.1 Clinical Evaluation Method
The proposed device performed a reader study of sample clinical data as clinical evaluation. The image quality was scored by 2 board-certified U.S. radiologists to perform a five-point scale evaluation of both image sets on three image quality aspects: noise, structure fidelity and overall image quality.
8.2.2 Testing Data Information
The clinical datasets in the evaluation covered different head, chest, abdomen and cardiac protocol, common diseases, different scanning dose and a wide range of population. The datasets were reconstructed with DELTA and FBP.
The performance testing for DELTA algorithm was performed on 60 subjects during the product development.
The validation dataset includes 20 cases, with 5 cases for each body part-abdomen, chest, head, and cardiac-scanned at a normal dose and reconstructed using normaldose FBP, as well as simulated low-dose DELTA images.
The test dataset includes 40 cases, with 10 cases for each body part-abdomen, chest, head, and cardiac-scanned at various doses and reconstructed using FBP and DELTA.
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Image /page/9/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.
Validation data & Testing Data Independence
Training dataset do not contain any validation dataset or test dataset of DELTA algorithm.
| Body Part | Number | Age | Sex | Dose Distribution |
|---|---|---|---|---|
| Head | 15 | 27-82 | 6 male | |
| 9 female | ≥70%: 10 | |||
| 30%-70%: 3 |