This device is indicated to acquire and display cross-sectional volumes of the whole the 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, of the whole organ by a trained and qualified physician.

Device Description

Aquilion ONE (TSX-306A/3) V10.0 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, c by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on what is explicitly stated:

Acceptance Criteria and Reported Device Performance

The provided document describes modifications to an existing Computed Tomography (CT) system (Aquilion ONE) and seeks clearance based on substantial equivalence to a predicate device. The core "acceptance criteria" here relate to demonstrating that the modified device performs similarly to or better than the predicate device, particularly concerning image quality, and that the modifications do not introduce new safety concerns.

The study presented focuses not on the clinical performance of an AI algorithm, but on demonstrating the image quality equivalence of the modified CT system (Aquilion ONE (TSX-306A/3) V10.0) compared to its predicate (Aquilion ONE (TSX-305A/6) V8.9 with AiCE).

Acceptance Criteria Category	Specific Criteria (Implicit from Testing)	Reported Device Performance
Image Quality	Standard deviation of noise (CT number accuracy)	Demonstrated substantial equivalence to predicate device.
	Image Standard Deviation (SD)	Demonstrated substantial equivalence to predicate device.
	Spatial Resolution (High Contrast Detectability)	Demonstrated substantial equivalence to predicate device.
	Density Resolution (Low Contrast Detectability)	Demonstrated substantial equivalence to predicate device.
Safety	Conformance to Quality System Regulations (21 CFR § 820 and ISO 13485 Standards)	Compliant
	Conformance to applicable IEC standards (e.g., IEC60601-1-1, IEC60601-2-28)	Compliant
	Conformance to radiation safety performance standards (21 CFR §1010 and §1020)	Compliant
Software	Adherence to FDA guidance for software in medical devices (Moderate Level of Concern)	Software documentation included and validated.
Cybersecurity	Adherence to FDA guidance for cybersecurity in medical devices	Cybersecurity documentation included.

Study Details

It's important to note that this submission is for a CT system hardware and software update, not a separate AI-driven diagnostic device or AI assistance tool for human readers. Therefore, many of the typical questions for AI performance studies (like human reader improvement with AI, ground truth for AI training, etc.) are not directly applicable to this specific submission. The "study" here is a technical verification rather than a clinical trial.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the sense of patient data. The testing was phantom-based. The document does not specify the number of phantoms used, but describes the type of tests performed (e.g., assessing different image quality parameters).
- Data Provenance: Not applicable as it was phantom-based testing, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for phantom-based image quality metrics is inherently defined by the physical characteristics of the phantom and the measurement techniques, not by expert interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was phantom-based objective measurement, not subjective expert adjudication of clinical cases.
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, an MRMC comparative effectiveness study was not done. This submission is for a CT system update, not an AI assistance device that impacts human reader performance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a CT scanner, not a standalone AI algorithm. While the predicate device included "AiCE" (Canon's Advanced Intelligent Clear-IQ Engine, an AI-based reconstruction technology), the primary focus of this submission's testing is on the general image quality equivalence of the updated system with its modified hardware and software, rather than a specific performance study of AiCE itself or any new AI feature. The subject device removes AiCE as an option from this specific version, indicating the focus is elsewhere.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective physical measurements from phantom-based tests. The "ground truth" for image quality metrics like noise, spatial resolution, and density resolution is established through controlled measurements of known phantom properties, not clinical outcomes or expert consensus.
The sample size for the training set:
- Not applicable. This document describes the verification of a modified CT system, not the training of a new AI model.
How the ground truth for the training set was established:
- Not applicable. (See #7).

Summary

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September 6, 2019

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

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

Re: K192188

Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 12, 2019 Received: August 13, 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 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-reporting

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combination-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 medical devices and radiation-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)

K192188

Device Name

Aquilion ONE (TSX-306A/3) V10.0

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.

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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510(k) SUMMARY

1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT: Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
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:
  August 30, 2019
1. TRADE NAME(S): Aquilion ONE (TSX-306A/3) V10.0

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

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

Made For life

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10. PREDICATE DEVICE:

Product	Marketed by	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
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

11. REASON FOR SUBMISSION:

Modification of existing medical 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, with the capability to image whole organs in a single rotation. Whole organs include, but are not limited to brain, heart, pancreas, etc.

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-306A/3) V10.0 is substantially equivalent to Aquilion ONE (TSX-305A/6) V8.9 with AiCE, which received premarket clearance under K183046, and is marketed by Canon Medical Systems USA. The intended use and the indications for use of the Aquilion ONE is the same as that of the predicate device. The Aquilion ONE (TSX-306A/3) V10.0 includes changes made to the predicate device including modifications made to the X-ray generator, gantry and detector in order to support rapid kV switching scans, the Windows operating system version is updated to Windows 10 from Windows 7, and to update the 5085Fluoro operating panel. 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	Aquilion ONE(TSX-305A/6) V8.9with AiCE
510(k) Number	This submission	K183046
X-ray generator(HFG)	CXXG-018A	CXXG-013A	Modifications to support rapid kVswitching-X-ray high-voltage generator upgradekit, Model CXGS-020A, also available toupgrade existing TSX-305A systems.-CXXG-013A with CXGS-020A isequivalent to the high voltage generatorused in TSX-306A. Model CXXG-018A.

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	Subject Device	Predicate Device	Comment
Device Name,Model Number	Aquilion ONE,TSX-306A/3	Aquilion ONE(TSX-305A/6) V8.9with AiCE
510(k) Number	This submission	K183046
Gantry	Model CGGT-039A	CGGT-036A	Modifications to support rapid kVswitching and acquisition viewsynchronization capabilities
- Exterior covers	Surface and paint withgloss coating	Surface and paint	Gloss coating is added
Detector model	CDAS-052A/6A	CDAS-052A/5A	Modifications to support the rapid kVswitching and kV view synchronization.No change in the hardware.
Type of X-ray tube	CXB-750F	CXB-750F	Improvement for stabilization duringelectrical discharge
Rear operatingpanel kit(CAGP-003A)	Option(Paint with gloss coating)	Option(Paint)	Gloss coating is added
System SoftwareVersion	V10.0	V8.9	Change
Console operatingsystem	Windows 10	Windows 7	Upgrade
SURE Fluoro	OptionTSXF-004A	OptionTSXF-0031	ChangeUpdated operating panel installed on thepatient couch
AiCE	N/A	Option	Change
FIRST	N/A	Option	Change

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, IEC60601-1-3, 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 Ionizing 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. An image quality evaluation using phantom-based tests was performed to compare the Aquilion ONE (TSX-306A/3) V10.0 and the predicate device. Results of the testing demonstrated substantial equivalence of image

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quality between the systems, with regard to standard deviation of noise (CT number accuracy, image SD, spatial resolution (high contrast detectability) and density resolution (low contrast detectability)). As a result of the phantom-based tests, it was determined that clinical data was not necessary to demonstrate substantial equivalence between the Aquilion ONE (TSX-306A/3) V10.0 and the predicate device.

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 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.