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, cardiac, extremities, head and inner ear applications.

Device Description

Aquilion Exceed LB (TSX-202A/3) V10.9 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.

AI/ML Overview

The provided document is a 510(k) summary for the Canon Medical Systems Corporation's Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i. It discusses the device's substantial equivalence to a predicate device, focusing on an expanded clinical use for the AiCE (Advanced Intelligent Clear-IQ Engine) feature, specifically to include cardiac applications.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating that the subject device performs similarly to or better than the predicate device. The acceptance criteria are implicitly tied to maintaining or improving upon the predicate's performance, particularly in image quality and the diagnostic utility of AiCE-reconstructed images.

Acceptance Criteria (Implicit)	Reported Device Performance
Image Quality Metrics (measured via phantoms):	Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i demonstrated:
Contrast-to-Noise Ratios (CNR)	Substantially equivalent or improved performance relative to the predicate device.
CT Number Accuracy	Substantially equivalent or improved performance relative to the predicate device.
Uniformity	Substantially equivalent or improved performance relative to the predicate device.
Slice Sensitivity Profile (SSP)	Substantially equivalent or improved performance relative to the predicate device.
Modulation Transfer Function (MTF)	Substantially equivalent or improved performance relative to the predicate device.
Standard Deviation of Noise (SD)	Substantially equivalent or improved performance relative to the predicate device.
Noise Power Spectra (NPS)	Substantially equivalent or improved performance relative to the predicate device.
Low Contrast Detectability (LCD)	Substantially equivalent or improved performance relative to the predicate device.
Dual Energy (Electron Density):	For Electron Density using the CBCT Electron Density Phantom:
Mean and SD error within established criteria	The mean and SD error between measured and true Electron Density values fall within the established criteria. Precise electron density accuracy is maintained throughout the field of view with monoenergetic images.
Dual Energy (Effective Atomic Number Map):	For Effective Atomic Number Map using the Catphan 700 phantom:
Mean and SD error within established accuracy criteria	The mean and SD error between measured and true Effective atomic number images fall within the established accuracy criteria.
Dual Energy (CT Number Accuracy):	For CT Number Accuracy using the Catphan 600 phantom:
Precise CT number accuracy throughout the field of view (70keV)	Precise CT number accuracy is maintained throughout the field of view on 70keV monoenergetic images.
AiCE Diagnostic Image Quality (Cardiac Application):	For cardiac diagnostic images reconstructed with AiCE:
Images of diagnostic quality	Representative cardiac diagnostic images were obtained using the subject device, and it was confirmed by an American Board Certified Radiologist that the AiCE reconstructed images were of diagnostic quality. This indicates the acceptance criteria for diagnostic utility for the new cardiac application were met, maintaining the expected standard of image quality provided by the AiCE feature for other cleared applications.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify exact sample sizes for the phantom studies (e.g., number of scans, repetitions). For the human review of cardiac images, it states "Representative cardiac diagnostic images," but does not provide a numerical count.
Data Provenance: The document implies the studies were conducted internally by Canon Medical Systems, given the context of a 510(k) submission. No specific country of origin is mentioned for the data, but the submitter is based in Japan (Canon Medical Systems Corporation, Shimoishigami Otawara-Shi, Tochigi-ken, Japan). The studies are inherently "prospective" in the context of validating the device for its submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: For the evaluation of cardiac diagnostic images, only one expert is explicitly mentioned: "reviewed by an American Board Certified Radiologist."
Qualifications of Experts: The expert was an "American Board Certified Radiologist." No specific tenure or experience level is mentioned beyond being Board Certified.

4. Adjudication Method for the Test Set

For the phantom studies, no human adjudication is mentioned, as the results are based on objective image quality metrics.
For the cardiac diagnostic image review, with only one radiologist reviewing, there was no adjudication method described (e.g., no 2+1 or 3+1 consensus process). The assessment was a single expert's confirmation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not explicitly done or described. The document focuses on technical bench testing (phantom studies) and a single expert's review of "representative cardiac diagnostic images" to confirm diagnostic quality. There is no mention of human readers improving with or without AI assistance, or any comparative analysis of human performance. The AiCE itself is a noise reduction algorithm, not a diagnostic AI intended to assist human interpretation directly in terms of detection or diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, in essence, standalone performance (algorithm only) was assessed for the AiCE feature. The "Image Quality Evaluation" using phantoms measured the intrinsic performance of the AiCE algorithm (and the overall system) in terms of various image quality metrics (CNR, CT Number Accuracy, etc.). These are objective measurements of the algorithm's output quality, independent of human interpretation.
The "Dual Energy" phantom studies also represent a form of standalone performance assessment for those features of the system.

7. The Type of Ground Truth Used

Physiological Phantom Measurements: For the bulk of the image quality and dual-energy assessments, the ground truth was established by known physical properties of phantoms. These phantoms are designed with specific, measurable characteristics (e.g., known electron densities, accurate CT numbers, specific contrast elements) that serve as the "true" values against which the device's measurements are compared.
Expert Consensus (single expert): For the "representative cardiac diagnostic images," the ground truth regarding "diagnostic quality" relied on the opinion/assessment of a single American Board Certified Radiologist. While not a "consensus" in the multi-reader sense, this expert's judgment served as the ground truth for diagnostic utility in this specific clinical application.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the AiCE Deep Convolutional Network. Information on training data is typically proprietary and not included in 510(k) summaries unless specifically relevant to substantial equivalence arguments.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth was established for the training set of the AiCE Deep Convolutional Network. This information is usually part of the internal development and validation of the AI algorithm itself, which predates the specific 510(k) submission for this device modification.

Summary

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September 10, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K211828

Trade/Device Name: Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 20, 2021 Received: August 23, 2021

Dear Orlando Tadeo, Jr.:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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) K211828

Device Name

Aquilion Exceed LB (TSX-202A/3) V10.9 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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

1. 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

1. DATE PREPARED:
  June 11, 2021
1. TRADE NAME(S): Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i

7. COMMON NAME:

Computed Tomography X-ray system

8. DEVICE CLASSIFICATION:

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

1. PRODUCT CODE:
  JAK

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

K211828

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11. PREDICATE DEVICE:

Product	Marketed by	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
Primary:Aquilion Exceed LB(TSX-202A/3) V10.6with AiCE-i	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K203042	12/10/2020
Reference:Dual Energy SystemPackage, CSDP-001A	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K132813	02/06/2014

12. REASON FOR SUBMISSION:

Modification of an existing device to expand the clinical use of AiCE to cardiac applications

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion Exceed LB (TSX-202A/3) V10.9 with AiCE-i is substantially equivalent to Aquillion Exceed LB (TSX-202A/3) V10.6 with AiCE-i, which received premarket clearance under K203042, and is marketed by Canon Medical Systems USA. The changes made to the subject device include expansion of the clinical use of AiCE to include cardiac applications (previously cleared under K192832), introduction of Dual Energy imaging (originally cleared under K132813) including new features and implementation of SOREStart and Single Energy Metal Artifact Reduction (SEMAR) to the XL scan field. A comparison of the technological characteristics between the subject and the predicate device is included below.

	Subject Device	Primary Predicate Device
Device Name,Model Number	Aquilion Exceed LB(TSX-202A/3) V10.9 with AiCE-i	Aquilion Exceed LB(TSX-202A/3) V10.6 with AiCE-i
510(k) Number	This submission	K203042
SUREStart	12 measurements/sApplicable to the XL scan field.	12 measurements/s
	Subject Device	Primary Predicate Device
Device Name, Model Number	Aquilion Exceed LB(TSX-202A/3) V10.9 with AiCE-i	Aquilion Exceed LB(TSX-202A/3) V10.6 with AiCE-i
510(k) Number	This submission	K203042
Parameter editing	Up to 7 pairs of Volume andMultiview reconstructions can beprescribed.	Up to 3 pairs of Volume andMultiview reconstructions can beprescribed.
Metal Artifact Reduction	Single Energy Metal ArtifactReduction (SEMAR)Applicable to the XL scan field.	Single Energy Metal ArtifactReduction (SEMAR)
Noise ReductionProcessing	Quantum Denoising Software(QDS)Adaptive Integrative DoseReduction 3D (AIDR 3D),AIDR 3D EnhancedAiCE(Advanced Intelligent Clear - IQEngine)• Abdomen and Pelvis• Chest• Extremities• Brain• Inner ear• Cardiac	Quantum Denoising Software(QDS)Adaptive Integrative DoseReduction 3D (AIDR 3D),AIDR 3D EnhancedAiCE(Advanced Intelligent Clear - IQEngine)• Abdomen and Pelvis• Chest• Extremities• Brain• Inner ear
Dual energy systempackage(CSDP-001A)	AvailableNew Features:Generation of Electron DensityMapGeneration of Effective AtomicNumber Map	N/A
Extended field of view(CSTC-005A)	AvailableCan be set with SEMAR	Available
Magnifiedreconstruction -Available magnificationSize (D-FOV)	BODY / BODY SHARP: Min. 100 mmLUNG: Min. 100 mmBONE: Min. 50 mmINNER EAR: Min. 50 mmBRAIN LCD / CTA: Min. 100 mmCARDIAC: Min. 70 mmMax. 700 (900) mmOption	BODY / BODY SHARP: Min. 100mmLUNG: Min. 100 mmBONE: Min. 50 mmINNER EAR: Min. 50 mmBRAIN LCD / CTA: Min. 100 mmMax. 700 (900) mmOption

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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, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, 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]

17. TESTING

Risk analysis and verification/validation activities conducted through bench testing demonstrate that the established specifications for the device have been met.

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), Noise Power Spectra (NPS) and Low Contrast Detectability (LCD). 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.

Dual Energy - Electron Density

Phantom studies were conducted using the CBCT Electron Density Phantom and the results demonstrated that the mean and SD error between the measured and true Electron Density values fall within the established criteria and that precise electron density accuracy is maintained throughout the field of view with monoenergetic images.

Dual Energy – Effective Atomic Number Map

A phantom study was conducted using the Catphan 700 phantom and the results demonstrated that the mean and SD error between the measured and true Effective atomic number images fall within the established accuracy criteria.

Dual Energy - CT Number Accuracy

A phantom study was conducted using the Catphan 600 phantom and the results demonstrated that precise CT number accuracy is maintained throughout the field of view on 70keV monoenergetic images.

Representative cardiac diagnostic images, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the AiCE reconstructed 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.

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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) V10.9 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.