This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Exceed LB has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, extremities, head and inner ear applications.

Device Description

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i (Advanced intelligent Clear-IQ Engineintegrated) 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, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

In addition, the subject device incorporates the latest reconstruction technology, AiCE-i (Advanced intelligent Clear-IQ Engine - integrated), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Network methods. These methods can more fully explore the statistical properties of the signal and noise. By learning to differentiate structure from noise, the algorithm produces fast, high quality CT reconstruction. The AiCE algorithm has not been modified or retrained since the previous clearance in the predicate, K192832.

AI/ML Overview

The provided text is a 510(k) summary for the Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i, a Computed Tomography (CT) system. The document focuses on demonstrating substantial equivalence to a predicate device (Aquilion Prime SP with AiCE-i, K192832) primarily through bench testing and phantom studies, rather than a clinical multi-reader, multi-case (MRMC) study with human subjects. Therefore, many of the requested criteria related to clinical study design and human reader performance are not directly addressed in this submission.

Here's a breakdown based on the provided information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by demonstrating "substantially equivalent or improved performance relative to the predicate device" in various image quality metrics and dose reduction, based on phantom studies. Quantitative targets are stated for some metrics.

Acceptance Criteria (Implicit from Testing)	Reported Device Performance (Phantom Study Results)
CT image quality metrics (Contrast-to-Noise Ratios (CNR), CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF), Standard Deviation of Noise (SD), Noise Power Spectra (NPS))	Aquilion Exceed LB system demonstrated substantially equivalent or improved performance relative to the predicate device for all tested metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF, SD, NPS).
Dose reduction with AiCE	Up to 82% dose reduction for AiCE Abdomen relative to FBP.
Improved high contrast spatial resolution with AiCE Body STD	Improved high contrast spatial resolution documented (quantitative values not explicitly stated, but "supported" by the study).
Simultaneous 50% noise reduction with AiCE Body STD	50% noise reduction documented (quantitative values not explicitly stated, but "supported" by the study).
Noise appearance/texture similarity to high dose FBP (compared to MBIR)	Noise appearance/texture is more similar to high dose filtered backprojection, compared to MBIR.
Low contrast detectability and noise reduction with AIDR (vs FBP)	63% improved low contrast detectability and 57.8% noise reduction with AIDR at the same dose for body compared to FBP.
Low contrast detectability and noise reduction with AiCE (vs FBP)	87% improved low contrast detectability and 67.2% noise reduction with AiCE at the same dose for body compared to FBP.
PUREViSION Optics: Low contrast detectability and dose reduction for Body CT	22% improved low-contrast detectability and 27.5% dose reduction at the same dose for Body CT.
PUREViSION Optics: Low contrast detectability for Brain CT	Improved low contrast detectability at the same dose for Brain CT.

2. Sample size used for the test set and the data provenance

The testing described is primarily bench testing utilizing phantoms. Therefore, the "sample size" refers to the number of phantom acquisitions and measurements, not patient data. The provenance is internal to the manufacturer's testing facility, as it's not a clinical study. The data is prospective in the sense that the tests were specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this submission. The ground truth for phantom studies is established by the physical properties of the phantom and known input parameters. No human experts were used for ground truth establishment as it was not a clinical reading study.

4. Adjudication method for the test set

Not applicable. Since the measurements are quantitative from phantom studies, human adjudication is not part of the process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case comparative effectiveness study involving human readers was not reported in this 510(k) summary. The submission explicitly states: "Representative clinical images were not necessary to demonstrate substantial equivalence of the subject device." The focus was on engineering performance demonstrated through phantom studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance of the AiCE algorithm (as integrated into the CT system, referred to as "AiCE-i") was evaluated in a standalone manner using phantom studies. The results in the table above demonstrate the algorithm's impact on image quality metrics and noise reduction. The AiCE algorithm itself was not modified or retrained since its previous clearance (K192832), indicating its performance characteristics are presumed stable.

7. The type of ground truth used

The ground truth used for these performance tests was phantom-based. This includes:

Physical properties of the phantoms (e.g., known material densities, lesion sizes, contrast values).
Quantitative measurements derived from the phantom scans (e.g., comparing reconstructed values to known phantom values).
Comparison to gold standards for image quality metrics (e.g., ideal MTF, NPS curves).

8. The sample size for the training set

The document states that "The AiCE algorithm has not been modified or retrained since the previous clearance in the predicate, K192832." This means the training of the AiCE algorithm itself was done prior to the submission for the predicate device. The actual sample size for the training data is not provided in this specific 510(k) summary (K203042). It would have been part of the K192832 submission.

9. How the ground truth for the training set was established

The document does not detail how the ground truth for the training data of the AiCE algorithm was established, as the algorithm itself was not retrained for this submission. This information would typically be found in the original submission for the AiCE algorithm (K192832). Generally, for deep learning algorithms in medical imaging, ground truth for training data is established through a combination of expert consensus, high-quality reference scans, or other validated methods, but this is not specified here.

Summary

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December 10, 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 and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K203042

Trade/Device Name: Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 5, 2020 Received: October 6, 2020

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

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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

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Indications for Use

510(k) Number (if known)

K203042

Device Name Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i

Indications for Use (Describe)

This device is indicated to acquire and display cross-sectional volumes of the whole the head. The Aquilion Exceed LB has the capability to provide volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, extremities, head and inner ear applications.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K203042

510(k) SUMMARY

SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

1. OFFICIAL CORRESPONDENT: Fumiaki Teshima Senior Manager, Quality Assurance Department
1. 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

ട. DATE PREPARED:
October 5, 2020
1. TRADE NAME(S): Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i

7. COMMON NAME:

System, X-ray, Computed Tomography

8. DEVICE CLASSIFICATION:

a) Classification Name: Computed Tomography X-ray system b) Regulation Number: 21 CFR §892.1750 c) Regulatory Class: Class II

9. PRODUCT CODE / DESCRIPTION:

90JAK / Computed Tomography X-Ray System

10. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

PHONE: 800-421-1968 2441 Michelle Drive, Tustin, CA 92780

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11. PREDICATE DEVICE:

Product	Marketed by	Regulation Number	Regulation Name	Product Code	510(k) Number	Clearance Date
Primary:Aquilion Prime SP(TSX-303B/8) V10.2with AiCE-i	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K192832	02/21/2020
Reference Device:Aquilion LB, TSX-201A/3, V6.0	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K150003	03/19/2015

12. REASON FOR SUBMISSION:

New device

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i is substantially equivalent to Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i, which received premarket clearance under K192832, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Exceed LB is the same as that of the predicate device. Additionally, Aquilion LB (TSX-201A/3) V6.0, is included in this submission as a Reference Device due to its similarity with the subject device with regard to the gantry size opening of 900mm. A comparison of the technological characteristics between the subject and the predicate device is included below.

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	Subject Device	Primary Predicate Device
Device Name,Model Number	Aquilion Exceed LB(TSX-202A/3) V10.6 with AiCE-i	Aquilion Prime SP (TSX-303B/8)V10.2 with AiCE-i
510(k) Number	This submission	K192832
Scan (Rotation) time	(0.26), 0.4, 0.45, 0.5, 0.6, 0.75,1, 1.5, 2, 3 s	(0.23), 0.35, 0.375, 0.4, 0.45,0.5, 0.6, 0.75, 1, 1.5, 2, 3 s
View rate	Max. 2400 views/s (0.5 s)	Max. 2572 views/s (0.35 s)
Scan field diameter(Field of View)	320/550/700 mm	320/500 mm
Extended Field of View	Available	Available
Gantry opening diameter	900 mm	780 mm
Gantry tilt	No tilt	±30°Axial and helical scanningGantry and remote controlled
Wedge Filter Types	Two typesSmall: FOV MLarge: FOV L and XL	Two typesSmall: FOV MLarge: FOV L
Detector	PURE ViSION detector	PURE ViSION detector
Data acquisition	1136 channels × 80 rows	896 channels × 80 rows
X-ray generation
• Channel-direction (fan) angle	52.2°	49.2°
• Slide-direction (cone) angle	3.22°	3.8°
• Rated output	Max.72 kW	Max.72 kW
• X-ray tube voltage	80/100/120/135 kV	80/100/120/135 kV
• X-ray tube current	10-500 mA (10-600 mA)	10-500 mA (10-600 mA)
• X-ray tube heat capacity	7.5 MHU	7.5 MHU
• X-ray tube cooling rate	Max. 1,386 kHU/min (16.5 kW)Actual 1,008 kHU/min (12.0 kW)	Max. 1,386 kHU/min (16.5 kW)Actual 1,008 kHU/min (12.0 kW)
Metal Artifact Reduction	Single Energy Metal ArtifactReduction (SEMAR)	Single Energy Metal ArtifactReduction (SEMAR)
Noise reduction processing	• Quantum Denoising Software(QDS)• Adaptive Integrative DoseReduction 3D (AIDR 3D)• AIDR 3D Enhanced• AiCE (Body, Lung, Bone, Brain,Inner Ear)	• Quantum Denoising Software(QDS)• Adaptive Integrative DoseReduction 3D (AIDR 3D)• AIDR 3D Enhanced• AiCE (Body, Lung, Cardiac,Bone, Brain, Inner Ear)
Respiratory-gating system	Available	Available
Couch lateral movement	+85mm	+42mm

16. 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, IEC60601-1-1, IEC60601-1-3, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, 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.

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This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

17. TESTING

Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met. These studies compared both FBP and AiCE reconstructions in the predicate and subject devices.

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), Standard Deviation of Noise (SD) and Noise Power Spectra (NPS). It was concluded that the Aquilion Exceed LB system demonstrated substantially equivalent or improved performance relative to the predicate device as demonstrated by the results of the above testing.

Dose Reduction with AiCE

A phantom study was conducted using the MITA-FDA LCD Body phantom and the results demonstrated a dose reduction of up 82% for AiCE Abdomen, relative to FBP.

Quantitative Spatial Resolution

A comparison study was conducted, utilizing phantoms, in order to support a quantitative spatial resolution improvement claim of improved high contrast spatial resolution and simultaneous 50% noise reduction with AiCE Body STD.

Noise Texture

An analysis of the NPS and kurtosis values for FBP, FIRST and AiCE was conducted and the results of the study support the following claim, noise appearance/texture is more similar to high dose filtered backprojection, compared to MBIR.

Quantitative Body LCD and Noise Improvement

A phantom study was conducted using the MITA-FDA LCD Body phantom and the results demonstrated 1) 63% improved low contrast detectability and noise reduction of 57.8% with AIDR at the same dose for body compared to FBP and 2) 87% improved low contrast detectability and noise reduction of 67.2% with AiCE at the same dose for body compared to FBP.

PUREViSION Optics

Phantom studies were conducted using the MITA-FDA LCD Body phantom and the results demonstrated 22% improved in low-contrast detectability and dose reduction of 27.5% at the same dose for Body CT and improved low contrast detectability at the same dose for Brain CT.

Representative clinical images were not necessary to demonstrate substantial equivalence of the subject device.

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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.

18. CONCLUSION

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i 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 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.

Regulation Number and Section

§ 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.