The Aquilion Prime SP 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 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

The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. An optional Dynamic Volume CT Upgrade Kit can be installed in order to expand the active detector rows to 80. 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.

AI/ML Overview

The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i is a CT x-ray system, and information on its acceptance criteria and the study proving it is provided below:

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

Acceptance Criteria (Claims)	Reported Device Performance
Improved Quantitative high contrast Spatial Resolution over AIDR 3D with reduced noise	Confirmed through MTF-Wire and MTF-Edge tests.
Improved Quantitative Dose Reduction over FBP	82% dose reduction relative to FBP.
Better Low-contrast Detectability than AIDR 3D for abdomen at the same dose	13.8% improved low contrast detectability compared to AIDR 3D.
Noise appearance/texture more similar to high dose filtered backprojection compared to MBIR	Supported by analysis of NPS and kurtosis values for FBP, FIRST, and AiCE. Claims state "Noise appearance/texture more similar to high dose filtered backprojection compared to MBIR," "Noise appearance/texture more similar to filtered backprojection compared to MBIR," "Improved noise appearance/texture compared to MBIR," and "More natural noise texture compared to MBIR."
Reduced noise (quantitative)	21.4% noise reduction at the same dose for the body compared to AIDR 3D.
Low-contrast detectability of 1.5 mm at 0.3%, 21.8mGy, using AiCE Body	Confirmed through a phantom study.
AiCE reconstructed images are of diagnostic quality for various applications (abdomen, pelvis, lung, cardiac, brain, extremities, and inner ear).	Representative images for these applications were reviewed by an American Board Certified Radiologist and confirmed to be of diagnostic quality.
Substantial equivalence in image quality metrics (CNR, CT Number Accuracy, Uniformity, SSP, SD, NPS, LCD, Pediatric phantom/protocol) compared to the predicate device.	Concluded that AiCE images are substantially equivalent to the predicate device based on the results of performed phantom studies for these metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a sample size for patient data. The testing primarily relies on phantom studies and a review of diagnostic images.
- Data Provenance: Not specified for any potential patient data. The document mentions "Representative abdomen/pelvis, lung, cardiac, brain, extremities and inner ear diagnostic images" were obtained using the subject device, suggesting prospective acquisition for evaluation, but this is not definitively stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the assessment of diagnostic image quality:
- Number of experts: One
- Qualifications of experts: An "American Board Certified Radiologist." Further details (e.g., years of experience) are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Based on the mention of a single American Board Certified Radiologist reviewing images, there was no multi-reader adjudication method (e.g., 2+1, 3+1) described for the diagnostic quality assessment. It appears to be a solitary expert's assessment.
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 multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is described in the provided text. The study focused on assessing image quality and specific performance metrics of the AI-integrated system (AiCE-i) through phantom studies and expert review of diagnostic images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, standalone testing of the algorithm (AiCE-i) was a primary component of the study. This is evidenced by:
- The extensive use of phantom studies to assess various image quality metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF, SD, NPS, LCD, etc.). These are objective measurements of the algorithm's output.
- Direct claims stating quantitative dose reduction (82%) and noise reduction (21.4%) by the AiCE algorithm relative to other reconstruction methods.
- Claims about improved low contrast detectability (13.8%) by the algorithm.
- Analysis of NPS and kurtosis values to assess noise appearance/texture of the algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for the evaluation can be categorized as follows:
- Objective Phantom Measurements: For quantitative image quality metrics like dose reduction, noise reduction, CNR, MTF, NPS, and LCD. The "ground truth" here is the physical properties of the phantom and the established measurement methodologies.
- Expert Radiologist Review: For confirming the "diagnostic quality" of the AiCE reconstructed images. The "ground truth" in this context is the qualitative assessment and professional judgment of the American Board Certified Radiologist.
8. The sample size for the training set

The document does not provide details on the sample size or characteristics of the training data used for the Deep Convolutional Network methods employed by AiCE-i.
9. How the ground truth for the training set was established

The document does not provide details on how the ground truth for the training set was established for the Deep Convolutional Network methods used by AiCE-i.

Summary

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February 21, 2020

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

Re: K192832

Trade/Device Name: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 17, 2020 Received: January 21, 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

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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,

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) K192832

Device Name

Aquilion Prime SP (TSX-303B/8) V 10.2 with AiCE-i

Indications for Use (Describe)

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion Prime SP 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.

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)

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Made For life

510(k) SUMMARY

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

2. OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance

3. 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

5. Date Prepared:

September 30, 2019

6. TRADE NAME(S):

Aquilion Prime SP (TSX-303B/8) V10.2 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: 892.1750 c) Regulatory Class: Class II

9. PRODUCT CODE / DESCRIPTION:

JAK – System, Computed Tomography

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

K192832

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10. PREDICATE DEVICE:

Product	Marketed by	RegulationNumber	RegulationName	Product Code	510(k)Number	Clearance Date
Aquilion Prime SP,TSX-303B/1, v8.4(Primary PredicateDevice)	CanonMedicalSystems, USA	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K172188	October 6, 2017
Aquilion ONE (TSX-305A/6) V8.9 withAiCE(Reference Device)	CanonMedicalSystems, USA	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K183046	June 12, 2019

11. REASON FOR SUBMISSION:

Modification of a cleared device

12. DEVICE DESCRIPTION:

13. INDICATIONS FOR USE:

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

The Aquilion Prime SP 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.

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i is substantially equivalent to Aquilion Prime SP, TSX-303B/1, v8.4, which received premarket clearance under K172188 and is marketed by Canon Medical Systems USA. The changes made to the subject device include the addition of AiCE (Advanced intelligent Clear-IQ Engine), a reconstruction that utilizes Deep Convolutional

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Neural Network methods to reduce image noise and improve image quality. A comparison of the technological characteristics between the subject and the predicate device is included below.

Item	Aquilion Prime SP (TSX-303B/8)V10.2 with AiCE-i	Aquilion Prime SP (TSX-303B/1) V8.4
510(k) ClearanceNumber	N/A	K172188
Anatomical Region	AIDR 3D (Whole Body)	AIDR 3D (Whole Body)
Noise ReductionProcessing	AiCE (Abdomen and Pelvis, Chest,Cardiac, Extremities, Brain, Inner ear)	AIDR 3DAIDR 3D EnhancedQuantum Denoising Smoothing (QDS)
	AIDR 3D
	AIDR 3D EnhancedQuantum Denoising Smoothing (QDS)AiCE
Processing capability	Console CKCN-020C	Console CKCN-017B
	Reconstruction processing system(AiCE-i: CSAL-001A)	Reconstruction processing system(N/A)

Display console kit	CGS-72B (Optional)	CGS-72A: TSX-303B/1 (Optional)
Image Quality Claims	- Improved Quantitative high contrastSpatial Resolution over AIDR 3D withreduced noise	No change
	- Improved Quantitative DoseReduction over FBP
	- Better Low-contrast Detectabilitythan AIDR 3D for abdomen at thesame dose
	-Noise appearance/texture moresimilar to high dose filteredbackprojection compared to MBIR

Operating System	Microsoft Windows 10	Microsoft Windows 7

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, IEC60601-1-9, IEC60601-1-2, IEC60601-1-3, 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 Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

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16. TESTING

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

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, Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD), Noise Power Spectra (NPS), Low Contrast Detectability (LCD) and Pediatric phantom/protocol. It was concluded that the AiCE images are substantially equivalent to the predicate device as demonstrated by the results of the above testing.

A dose reduction study was conducted using AiCE and based on the results, a dose reduction claim of 82%, relative to FBP, is supported as well as 13.8% improved low contrast detectability and noise reduction of 21.4 at the same dose for body compared to AIDR 3D.

Low Contrast Detectability

A phantom study was conducted in order to support claims of low-contrast detectability of 1.5 mm at 0.3%, 21.8mGy, using AiCE Body

Noise Texture Reader Study

An analysis of the NPS and kurtosis values for FBP, FIRST and AiCE was conducted and the results of the study support the following claims:

"Noise appearance/texture more similar to high dose filtered backprojection compared to MBIR"
"Noise appearance/texture more similar to filtered backprojection compared to MBIR"
"Improved noise appearance/texture compared to MBIR"
"More natural noise texture compared to MBIR"

Representative abdomen/pelvis, lung, cardiac, brain, extremities and inner ear 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.

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.

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17. CONCLUSION

The Aquilion Prime SP (TSX-303B/8) V10.2 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

N/A