(134 days)
Yes
The summary explicitly mentions "Deep Convolutional Neural Network methods" and "Deep Convolutional Network methods" in the description of the AiCE algorithm, which is a form of artificial intelligence/machine learning.
No.
This device is an imaging system (CT scanner) used for diagnostic purposes, specifically to acquire and display cross-sectional volumes of the body and perform specialized studies. While the acquired images can inform a physician's treatment decisions, the device itself does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" states the device is "indicated to acquire and display cross-sectional volumes of the whole the head..." and these "volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician." It also mentions that "a potential application is to determine the course of treatment" when used by a qualified physician. Furthermore, the "Summary of Performance Studies" section repeatedly refers to "diagnostic quality" of the images obtained from the device. These statements clearly indicate the device's role in providing information for diagnosis.
No
The device description explicitly states it is a "whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display." This indicates it includes significant hardware components beyond just software. While it utilizes software for image processing and reconstruction (FIRST, AiCE, Spectral Imaging), it is fundamentally a hardware-based imaging system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "whole body multi-slice helical CT scanner." It acquires and displays cross-sectional volumes of the head and whole organs using X-rays. This is an in vivo imaging technique, meaning it examines the body directly, not samples taken from the body.
- Intended Use: The intended use is to acquire and display images for diagnostic purposes, and to perform specialized studies using indicated software. This aligns with the function of a medical imaging device, not an IVD.
- Lack of Mention of Samples: There is no mention of analyzing biological samples or performing tests on them.
The device is a medical imaging system used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
No
The input text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
This device is indicated to acquire and display cross-sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, inner ear and extremities applications.
The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.
Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.
When used by a qualified physician, a potential application is to determine the course of treatment.
Product codes
JAK
Device Description
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
whole body, head, brain, heart, pancreas, abdomen, pelvis, chest, cardiac, extremities, inner ear, lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician / 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
Spectral Imaging Performance Testing - Bench
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). It was concluded that the Spectral Images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.
Catphan and Body Phantom Evaluation
A side-by-side study was conducted to compare the image quality between the predicate dual energy scanning versus the subject Spectral Imaging scanning at varying dose levels.
Other studies using various phantoms were conducted to support the following Spectral Imaging claims:
- Spectral Imaging reduces beam hardening artifact (relative to AIDR3D/FBP)
- High linear correlation between CT number and iodine concentration
Spectral Imaging Performance Testing – Clinical Images
Representative abdomen/pelvis, lung, and extremity Spectral Images, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the Spectral Imaging reconstructed images using the subject device were of diagnostic quality.
Non-Spectral Imaging and AiCE Performance Testing – Bench
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD) and Pediatric phantom/protocol. It was concluded that AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
Quantitative Body LCD, Noise Improvement, Dose Reduction
A model observer evaluation was conducted and the subject device demonstrated a dose reduction of 69-81% compared to filtered back projection, a 18.4% improvement in low contrast detectability and 32% noise reduction at the same dose for body AiCE compared to AIDR 3D.
Other studies using various phantoms were conducted to support the following claims:
- Streak and beam hardening artifacts appeared the same with AiCE as when FBP and AIDR 3D were used and additional artifacts were not introduced
- Twice the high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF
- AiCE noise appearance/texture more similar to high dose filtered backprojection (compared to FIRST)
- AiCE noise appearance/texture more similar to filtered backprojection (compared to FIRST)
- AiCE has improved noise appearance/texture (compared to FIRST)
- AiCE has more natural noise texture (compared to FIRST)
- Effective 144 (180 with option) kW max. equivalent generator power with AIDR
AiCE Imaging Performance Testing – Clinical Images
Representative abdomen/pelvis, brain, inner ear and extremity AiCE images were reviewed by an American Board Certified Radiologist. All images were obtained using the subject device and it was confirmed that the images were of diagnostic quality.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Spectral Imaging Performance Testing - Bench
- Study Type: Bench testing using phantoms
- Key Results: Spectral Images were found to be substantially equivalent to the predicate device based on CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, and LCD. A side-by-side comparison showed image quality comparable to the predicate dual energy scanning. Spectral Imaging reduces beam hardening artifact and shows high linear correlation between CT number and iodine concentration.
Spectral Imaging Performance Testing – Clinical Images
- Study Type: Clinical image review by an American Board Certified Radiologist
- Sample Size: Representative abdomen/pelvis, lung, and extremity Spectral Images
- Key Results: Confirmed that the Spectral Imaging reconstructed images using the subject device were of diagnostic quality.
Non-Spectral Imaging and AiCE Performance Testing – Bench
- Study Type: Bench testing using phantoms and model observer evaluation
- Key Results: AiCE was found to be substantially equivalent to the predicate device based on CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD, and Pediatric phantom/protocol. Demonstrated a dose reduction of 69-81% compared to filtered back projection, a 18.4% improvement in low contrast detectability, and 32% noise reduction at the same dose for body AiCE compared to AIDR 3D. Also showed that streak and beam hardening artifacts were not introduced, high contrast spatial resolution was improved, and noise appearance/texture was more natural and similar to high dose filtered backprojection.
AiCE Imaging Performance Testing – Clinical Images
- Study Type: Clinical image review by an American Board Certified Radiologist
- Sample Size: Representative abdomen/pelvis, brain, inner ear and extremity AiCE images
- Key Results: Confirmed that the images were of diagnostic quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Quantitative Body LCD: 18.4% improvement in low contrast detectability
- Noise Reduction: 32% noise reduction (for body AiCE compared to AIDR 3D at the same dose)
- Dose Reduction: 69-81% compared to filtered back projection
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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February 13, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K192828
Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 30, 2019 Received: December 31, 2019
Dear Mr. Tadeo:
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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192828
Device Name
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
Indications for Use (Describe)
This device is indicated to acquire and display cross-sectional volumes of the whole the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software, of the whole organ by a trained and qualified physician.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, inner ear and extremities applications.
The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The X-ray dose will be the sum of the dose at each respective tube voltage and current in a rotation.
Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies.
When used by a qualified physician, a potential application is to determine the course of treatment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image contains the text "K192828" on the top line, with the phrase "Made For life" on the second line. The text is in a simple, sans-serif font, with the phrase "Made For life" in a slightly larger and bolder font than the code above it. The text is black against a white background.
510(k) SUMMARY
-
- SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
-
- OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
-
- ESTABLISHMENT REGISTRATION: 9614698
4. CONTACT PERSON:
Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459
-
- DATE PREPARED:
September 30, 2019
- DATE PREPARED:
-
- TRADE NAME(S): Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
7. COMMON NAME:
System, X-ray, Computed Tomography
8. DEVICE CLASSIFICATION:
a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 892.1750 c) Regulatory Class: Class II
9. PRODUCT CODE / DESCRIPTION:
JAK / Computed Tomography X-Ray System
PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780
4
10. PREDICATE DEVICE:
| Product | Marketed by | Regulation
Number | Regulation
Name | Product Code | 510(k)
Number | Clearance
Date |
|---------------------------------------------------------------|----------------------------------|----------------------|----------------------------------------|---------------------------------------------------|------------------|-------------------|
| Primary:
Aquilion ONE (TSX-
306A/3) V10.0 | Canon
Medical
Systems, USA | 21 CFR
892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K192188 | 09/06/2019 |
| Reference:
Aquilion ONE (TSX-
305A/6) V8.9 with
AiCE | Canon
Medical
Systems, USA | 21 CFR
892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K183046 | 06/12/2019 |
| Reference:
Dual Energy System
Package, CSDP-001A | Canon
Medical
Systems, USA | 21 CFR
892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K132813 | 02/06/2014 |
| Reference:
Revolution CT | GE Medical
Systems,
L.L.C. | 21 CFR
892.1750 | Computed
Tomography
X-ray System | JAK:
System, X-ray,
Tomography,
Computed | K163213 | 12/16/2016 |
11. REASON FOR SUBMISSION:
Modification of existing medical device
12. DEVICE DESCRIPTION:
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
13. INDICATIONS FOR USE:
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.
The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, brain, inner ear and extremities applications.
The Spectral Imaging System allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The Xray dose will be the sum of the dose at each respective tube voltage and current in a rotation.
5
Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment.
14. SUBSTANTIAL EQUIVALENCE:
The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is substantially equivalent to Aquilion ONE (TSX-306A/3) V10.0, which received premarket clearance under K192188, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion ONE is the same as that of the predicate device. The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System includes changes made to the predicate device including implementation of Spectral Imaging System, AiCE and FIRST. A comparison of the technological characteristics between the subject and the predicate device is included below.
| Subject Device | Predicate Device | Comment | |
|---|---|---|---|
| Device Name, | |||
| Model Number | Aquilion ONE | ||
| (TSX-306A/3) V10.0 with | |||
| Spectral Imaging System | Aquilion ONE | ||
| (TSX-306A/3) V10.0 | |||
| 510(k) Number | This submission | K192188 | |
| Spectral Imaging System | |||
| (CSDE-004A) | Available | N/A | Reference Predicate |
| Device: K132813 | |||
| • Scan Type | -Rapid kV Switching | -Two consecutive volume | |
| scans with short tube | |||
| voltage switching | |||
| • Scan Regions | -Abdomen and pelvis, | ||
| Chest and Extremities | -Whole Body | ||
| • Spectral Reconstruction | |||
| Images | -Basis material image | ||
| -Monochromatic image | |||
| -Iodine Map | |||
| -VNC (virtual non- | |||
| contrast) image | N/A | ||
| Advanced Intelligent Clear-IQ | |||
| Engine (AiCE) | Available | N/A | Reference Predicate |
| Device: K183046 | |||
| • Scan Regions | Abdomen and Pelvis | ||
| Chest | |||
| Cardiac | |||
| Extremities* | |||
| Brain* | |||
| Inner ear* | Abdomen and Pelvis | ||
| Chest | |||
| Cardiac | |||
| *New scan regions | |||
| FIRST | |||
| (Forward projected model- | |||
| based Iterative Reconstruction | |||
| Solution) | Available | N/A | |
| Reconstruction processing | |||
| unit (CCRS-003A*) | Available | N/A | * Includes FIRST and AiCE |
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15. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA XR-25, NEMA XR-26 and NEMA XR-29. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.
This device conforms to applicable Performance Standards for lonizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]
16. TESTING
Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.
Spectral Imaging Performance Testing - Bench
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). It was concluded that the Spectral Images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.
Catphan and Body Phantom Evaluation
A side-by-side study was conducted to compare the image quality between the predicate dual energy scanning versus the subject Spectral Imaging scanning at varying dose levels.
Other studies using various phantoms were conducted to support the following Spectral Imaging claims:
- । Spectral Imaging reduces beam hardening artifact (relative to AIDR3D/FBP)
- । High linear correlation between CT number and iodine concentration
Spectral Imaging Performance Testing – Clinical Images
Representative abdomen/pelvis, lung, and extremity Spectral Images, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the Spectral Imaging reconstructed images using the subject device were of diagnostic quality.
Non-Spectral Imaging and AiCE Performance Testing – Bench
Image Quality Evaluation
CT image quality metrics were performed, utilizing phantoms, to assess Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP),
7
Modulation Transfer Function (MTF)-Wire, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD) and Pediatric phantom/protocol. It was concluded that AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.
Quantitative Body LCD, Noise Improvement, Dose Reduction
A model observer evaluation was conducted and the subject device demonstrated a dose reduction of 69-81% compared to filtered back projection, a 18.4% improvement in low contrast detectability and 32% noise reduction at the same dose for body AiCE compared to AIDR 3D.
Other studies using various phantoms were conducted to support the following claims:
- Streak and beam hardening artifacts appeared the same with AiCE as when FBP and AIDR 3D were used and additional artifacts were not introduced
- Twice the high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF
- AiCE noise appearance/texture more similar to high dose filtered backprojection (compared to FIRST)
- AiCE noise appearance/texture more similar to filtered backprojection (compared to FIRST)
- AiCE has improved noise appearance/texture (compared to FIRST)
- AiCE has more natural noise texture (compared to FIRST)
- Effective 144 (180 with option) kW max. equivalent generator power with AIDR
AiCE Imaging Performance Testing – Clinical Images
Representative abdomen/pelvis, brain, inner ear and extremity AiCE images were reviewed by an American Board Certified Radiologist. All images were obtained using the subject device and it was confirmed that the images were of diagnostic quality.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices " issued on October 2, 2014, is also included as part of this submission.
Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.
17. CONCLUSION
The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance
8
data presented in this submission it is concluded that the subject device has demonstrated substantial equivalence to the predicate device and is safe and effective for its intended use.