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

FIRST 3.0 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 Neural Network methods for abdomen and pelvis applications.

Device Description

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is an ultra-high resolution whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7-MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest reconstruction technology, AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural Network methods to 1024x1024 HR/SHR images. 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

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

Acceptance Criterion (Implicit)	Reported Device Performance and Confirmation
Image Quality (General)	- CT image quality metrics were performed: 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 water phantom. - "AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing." - "The AiCE reconstructed images were of diagnostic quality," as reviewed by an American Board Certified Radiologist.
Low Contrast Detectability (LCD) Improvement	- "AiCE demonstrated 13% improved low contrast detectability" for super-high resolution body at the same dose compared to AIDR 3D. - "superior LCD performance for super-high resolution body at the same dose for AiCE vs AIDR 3D."
Noise Reduction	- "AiCE demonstrated... 42% noise reduction for super-high resolution body at the same dose compared to AIDR 3D."
Dose Neutrality	- "it was demonstrated that there is dose neutrality between super-high resolution mode with AiCE and normal resolution mode with AIDR."
Spatial Resolution Improvement (High Contrast)	- "A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 8.8 lp/cm at 10% of the MTF for AiCE relative to AIDR 3D Standard for abdomen/body."
Diagnostic Quality of AiCE Images (Clinical)	- "Representative abdomen/pelvis 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."
Safety and Regulatory Compliance	- "The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards." - Conforms to applicable parts of IEC60601-1, IEC60601-1-2, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26 and NEMA XR-29. - Complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020. - Software Documentation for a Moderate Level of Concern included per FDA guidance. - Cybersecurity documentation included per FDA guidance. - Testing conducted in accordance with applicable IEC standards.

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

Sample Size for Test Set: The document mentions "Representative abdomen/pelvis diagnostic images" but does not specify the numerical sample size for this clinical review. For phantom studies, the concept of a "sample size" of images is less directly applicable; rather, it's about the number of measurements taken from the phantom.
Data Provenance: The document does not explicitly state the country of origin for the data. Given the manufacturer is Canon Medical Systems Corporation based in Japan, it's possible the data originated there or from a multi-national study. The document also does not specify if the data was retrospective or prospective. The use of "representative diagnostic images" suggests real-world data, but the study design (retrospective vs. prospective) is not detailed.

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

Number of Experts: "an American Board Certified Radiologist" (singular).
Qualifications of Experts: American Board Certified Radiologist. No specific number of years of experience is mentioned.

4. Adjudication Method for the Test Set

The document describes a review by a single American Board Certified Radiologist. Therefore, there was no adjudication method described for resolving disagreements, as only one expert was involved in this specific clinical image evaluation aspect. The primary testing relies on objective phantom measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not explicitly described. The document mentions a single radiologist's review for diagnostic quality confirmation.
The study primarily focuses on standalone performance improvements demonstrated through objective phantom measurements (noise reduction, LCD, spatial resolution) and the radiologist's qualitative assessment of diagnostic quality. It does not compare human readers with AI assistance versus human readers without AI assistance to quantify an "effect size" of improvement in human performance.

6. If a Standalone (i.e., Algorithm Only Without Human-In-The-Loop Performance) Was Done

Yes, a standalone performance evaluation was done. The phantom studies (CNR, CT Number Accuracy, Uniformity, SSP, MTF, SD, NPS, LCD, Pediatric water phantom) directly measure the performance characteristics of the AiCE algorithm as applied to CT data, without human interaction in the measurement process.
The reported improvements in low contrast detectability (13%), noise reduction (42%), and spatial resolution (8.8 lp/cm) are all measures of the algorithm's standalone performance.

7. The Type of Ground Truth Used

For the phantom studies, the "ground truth" is established by the known physical properties and measurements derived from the phantom itself, and standardized metrology for CT image quality. This is an objective, quantitative ground truth.
For the clinical image evaluation, the ground truth for "diagnostic quality" was established by expert consensus (of one expert), specifically an American Board Certified Radiologist.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set of the Deep Convolutional Neural Network (DCNN) for AiCE. This information is typically proprietary and not included in 510(k) summaries unless specifically requested or deemed critical for substantial equivalence in a novel device.

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

The document states that AiCE "improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods...By learning to differentiate structure from noise, the algorithm produces fast, high quality CT reconstruction." However, the document does not describe how the ground truth was established for the training data used to train this Deep Convolutional Neural Network. This is a critical piece of information for AI/ML-based devices but is not detailed in this 510(k) summary.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is 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: K182901

Trade/Device Name: Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 11, 2019 Received: July 12, 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

July 5, 2019

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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) K182901

Device Name

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

Indications for Use (Describe)

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen and pelvis applications.

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: June 11, 2019
1. TRADE NAME(S): Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

7. COMMON NAME:

System, X-ray, Computed Tomography

1. DEVICE CLASSIFICATION (Regulatory Class, CFR Reference, Name): Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)

9. PRODUCT CODE / DESCRIPTION: JAK / 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]

K182901

Made For life

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11. PREDICATE DEVICE:

Product	Marketedby	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
Aquilion Precision(TSX-304A/2) V8.6	CanonMedicalSystems,USA	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K173468	02/23/2018

12. REASON FOR SUBMISSION:

Modification of existing medical device

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

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

The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, by a trained and qualified physician.

AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen and pelvis applications.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE, is substantially equivalent to the Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0, which received premarket clearance under K173468 and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Precision is the same as that of the predicate device. The changes made to the subject device include the addition of AiCE (Advanced intelligent Clear-IQ Engine), a reconstruction algorithm that utilizes Deep Convolutional 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.

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Item	Aquilion Precision(TSX-304A/1 and 2) V8.8 with AiCE	Aquilion Precision(TSX-304A/2) V8.6K173468
Anatomical Region	Whole Body (FBP, AIDR 3D, FIRST)Abdomen and pelvis (AiCE)	Whole Body (FBP, AIDR 3D, FIRST)
Noise ReductionProcessing	AIDR 3DAIDR 3D EnhancedAiCE	AIDR 3DAIDR 3D Enhanced
Central processing unitmemory size	128 Gbytes or more	256 Gbytes or more
Patient couch - Frameslide stroke	310 mm	330 mm
Handy Snap*(CAXS-001A)	Optional	N/A
Dual energy system*package (CSDP-001A)	Optional	N/A

*Feature previously cleared under K141741. No changes made for implementation into the subject device.

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, IEC60601-1-2, IEC60601-1-6, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, 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.

17. TESTING

Risk analysis and verification/validation testing 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 water phantom. AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.

Low Contrast Detectability, Noise Reduction, Dose Neutrality

AiCE demonstrated 13% improved low contrast detectability and 42% noise reduction for superhigh resolution body at the same dose compared to AIDR 3D. Additionally, it was demonstrated that there is dose neutrality between super-high resolution mode with AiCE and normal resolution mode with AIDR as well as superior LCD performance for super-high resolution body at the same dose for AiCE vs AIDR 3D.

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Spatial Resolution

A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 8.8 lp/cm at 10% of the MTF for AiCE relative to AIDR 3D Standard for abdomen/body.

Representative abdomen/pelvis 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.

18. CONCLUSION

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE 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.