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 Network methods for abdomen, pelvis, lung, cardiac, brain, inner ear and extremities applications.

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.

Device Description

Aquilion ONE (TSX-306A/3) V10.4 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study Type
Image Quality Evaluation	Spectral Images are substantially equivalent to the predicate device.	Bench Test (Phantom Study)
Specific Metrics:
Contrast-to-Noise Ratios (CNR)	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
CT Number Accuracy	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Uniformity	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Slice Sensitivity Profile (SSP)	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Modulation Transfer Function (MTF)-Wire	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Standard Deviation of Noise (SD)	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Noise Power Spectra (NPS)	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Low Contrast Detectability (LCD)	Met expectations (substantially equivalent)	Bench Test (Phantom Study)
Dose Neutrality	Spectral 70keV was dose neutral with single energy AIDR 120KvP.	Bench Test (Phantom Study)
Noise Magnitude Reduction	Spectral 70keV images had 50% noise reduction compared to same dose single energy images.	Bench Test (Phantom Study)
Contrast to Noise Ratio Improvement	There was a 150% CNR improvement for iodine with Spectral 70keV relative to single energy AIDR, at the same dose.	Bench Test (Phantom Study)
Iodine Concentration Reduction	There was a 60% iodine concentration reduction at 60keV relative to 120kVp single energy AIDR.	Bench Test (Phantom Study)
Clinical Image Diagnostic Quality	Spectral Imaging reconstructed images using the subject device were of diagnostic quality.	Clinical Images Review

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

Bench Testing (Phantom Studies): The text indicates "phantoms" were used for various image quality and dose-related tests. Specific numbers of phantoms are not provided, nor is their provenance (obviously not country of origin for phantoms).
Clinical Images: "Representative abdomen/pelvis, lung, extremity and cardiac Spectral Images" were obtained. The exact sample size (number of images or patients) is not specified. The provenance (e.g., country of origin, retrospective/prospective) for these clinical images is also not explicitly stated, beyond being "representative."

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

Clinical Images: "An American Board Certified Radiologist" reviewed the clinical images. This indicates one expert.
Qualifications: American Board Certified Radiologist. The number of years of experience is not specified.

4. Adjudication Method for the Test Set

For the clinical images, the review was performed by a single American Board Certified Radiologist. This implies no multi-reader adjudication method (like 2+1 or 3+1). The radiologist's assessment directly served as the ground truth for diagnostic quality.

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 MRMC comparative effectiveness study is mentioned. The primary focus of the clinical image review was to confirm the diagnostic quality of the spectral images themselves, not to assess human reader performance with or without AI assistance. The device includes "AiCE is a noise reduction algorithm," but its impact on human reader performance is not evaluated in this submission documentation.

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

Yes, the majority of the image quality metrics (CNR, CT Number Accuracy, Uniformity, SSP, MTF-Wire, SD, NPS, LCD, Dose Neutral, Noise Reduction, CNR Improvement, Iodine Reduction) were evaluated in a standalone fashion using phantoms. This represents an algorithm-only performance assessment against predefined physical criteria.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for the bench tests was derived from known phantom properties and measurements against those properties (e.g., known iodine concentrations in phantoms, measurements of noise, etc.). This is essentially physical/objective measurements against known standards.
Clinical Images: The ground truth for the clinical images was expert opinion/consensus from a single American Board Certified Radiologist regarding diagnostic quality.

8. The Sample Size for the Training Set

The document does not specify a sample size for the training set for any algorithms (like FIRST or AiCE). The submission focuses on verification and validation of the device changes, not the development or training of its internal algorithms.

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

The document does not provide information on how the ground truth for the training set (if applicable to the algorithms like AiCE, which uses Deep Convolutional Network methods) was established. This information would typically be detailed during the development and initial validation of such algorithms, not necessarily in a submission for an updated device version that incorporates these existing algorithms.

Summary

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March 24, 2021

Image /page/0/Picture/1 description: The image shows 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, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K203225

Trade/Device Name: Aquilion ONE (TSX-306A/3) V10.4 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: February 18, 2021 Received: February 22, 2021

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) K203225

Device Name

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

Indications for Use (Describe)

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.

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)
【区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

K203225

1. SUBMITTER'S NAME: Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. ESTABLISHMENT REGISTRATION: 9614698

OFFICIAL CORRESPONDENT/CONTACT PERSON: 3.

Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

1. DATE PREPARED:
  October 30, 2020
1. TRADE NAME(S): Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

6. COMMON NAME:

System, X-ray, Computed Tomography

7. DEVICE CLASSIFICATION:

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

8. PRODUCT CODE / DESCRIPTION:

JAK / Computed Tomography X-Ray System

9. 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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10. PREDICATE DEVICE:

Product	Marketed by	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
Aquilion ONE (TSX-306A/3) V10.0 withSpectral ImagingSystem	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K192828	02/13/2020

11. REASON FOR SUBMISSION:

Modification of existing device to extend the range of the Spectral Imaging System to include cardiac and to improve image quality for existing Spectral scan regions.

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.

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.

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. 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.

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14. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is substantially equivalent to Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System, which received premarket clearance under K192828, 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) V10.4 with Spectral Imaging System includes changes made to the predicate device including addition of cardiac clinical region for the Spectral Imaging System, addition of marketing that Spectral offers the ability to optimize iodinated contrast media usage* , and image quality improvements to existing Spectral scan regions.

Optimization of contrast usage is only recommended within the dosing ranges that appear in approved iodinated contrast drug labeling.

	Subject Device	Predicate Device	Comment
Device Name,Model Number	Aquilion ONE(TSX-306A/3) V10.4 withSpectral Imaging System	Aquilion ONE(TSX-306A/3) V10.0 withSpectral Imaging System
510(k) Number	This submission	K192828
Spectral Imaging System(CSDE-004A)	Available	Available
• Scan Type	-Rapid kV Switching	-Rapid kV Switching
• Scan Regions	-Abdomen and pelvis,Chest, Extremitiesand Cardiac	-Abdomen and pelvis,Chest and Extremities	Addition of Cardiacscan region and imagequality improvementsto existing regions
• Spectral ReconstructionImages	-Basis material image-Monochromaticimage-Iodine Map-VNC (virtual non-contrast) image	-Basis material image-Monochromaticimage-Iodine Map-VNC (virtual non-contrast) image
• Metal ArtifactReduction (MAR)	Available	N/A
• ECG-gated scan	Available	N/A
• Gantry tilt	Available	N/A
• Rotation time	0.275, 0.5, 0.75 and1.0 s	0.5, 0.75 and 1.0 s

A comparison of the technological characteristics between the subject and the predicate device is included below.

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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, 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]

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.

Dose Neutral

A phantom study was conducted using the MITA-FDA LCD Body phantom and the results demonstrated that Spectral 70keV was dose neutral with single energy AIDR 120KvP.

Noise Magnitude Reduction and Texture

A phantom study was conducted using phantoms comparing Spectral 70keV and AIDR 120kVp standard deviation results and it was determined that Spectral 70keV images had 50% noise reduction compared to same dose single energy images.

Contrast to Noise Ratio Improvement

A study using the 33cm Gammex dual energy CT phantom was conducted and it was determined that there was a 150% CNR improvement for iodine with Spectral 70keV relative to single energy AIDR, at the same dose.

lodine Concentration Reduction

A study using the 33cm Gammex dual energy CT phantom with inserts of varying iodine concentration demonstrated that there was a 60% iodine concentration reduction at 60keV relative to 120kVp single energy AIDR.

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Spectral Imaging Performance Testing - Clinical Images

Representative abdomen/pelvis, lung, extremity and cardiac 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.

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) V10.4 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 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.