This device is indicated to acquire and display cross-sectional volumes of the whole 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 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, pelvis, lung, and cardiac applications.

Device Description

Aquilion Precision (TSX-304A/4) V10.10 with AiCE is an ultra-high resolution whole body multislice 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, c 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 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 supporting studies for the Aquilion Precision (TSX-304A/4) V10.10 with AiCE, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document doesn't explicitly lay out "acceptance criteria" in a typical pass/fail table format with specific numerical targets. Instead, it describes performance studies and their outcomes. The central theme is achieving substantial equivalence to the predicate device, often by demonstrating equivalent or improved performance in key areas.

Performance Metric / Area of Evaluation	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality (General Bench Testing)	Substantial equivalence to predicate device.	CT image quality metrics (CNR, CT Number Accuracy, Uniformity, SSPz, MTF-Wire, MTF-Edge, SD, NPS, LCD, Pediatric conditions) were performed utilizing phantoms. AiCE demonstrated substantial equivalence to the predicate device.
Noise Texture	AiCE images should have a more natural noise texture compared to FIRST images and be as natural as FBP.	An analysis of NPS and kurtosis values for FBP, FIRST, and AiCE concluded that AiCE images have a more natural noise texture compared to FIRST images, and AiCE noise texture is as natural as filtered backprojection (FBP) and distinct from MBIR images.
Quantitative Spatial Resolution Improvement	Demonstrate improvement in high contrast spatial resolution compared to hybrid iterative reconstruction.	Demonstrated high contrast spatial resolution improvement of: - 16.5 lp/cm for Body in HR mode - 10.5 lp/cm for Cardiac in HR mode - 15 lp/cm for Lung in HR mode - >10 lp/cm across all AiCE available body regions. (All compared to hybrid iterative reconstruction with conventional scanning at the same dose).
Dose Neutral/Equivalent LCD & HC Spatial Resolution (Body)	Dose neutral relative to AIDR normal resolution mode, equivalent LCD with AIDR normal resolution, and improved high contrast spatial resolution.	Study comparing Aquilion Precision HR (High Resolution) mode with AiCE Body Sharp to Aquilion Precision NR (Normal Resolution) mode with AIDR Body determined: - HR mode with AiCE is dose neutral relative to AIDR normal resolution mode. - HR mode with AiCE has equivalent Low Contrast Detectability relative to normal resolution mode. - AiCE has equivalent Low Contrast Detectability with 10 lp/cm more high contrast spatial resolution for body.
Lung Cancer Screening (Image Quality)	Equivalent or improved performance relative to predicate device (Aquilion ONE GENESIS with AIDR).	CT image quality metrics (CT Number Accuracy, Uniformity, SSP, MTF-Edge, SD, NPS) were performed utilizing phantoms relevant to Lung Cancer Screening. Results demonstrated equivalent or improved performance for the Aquilion Precision in HR and SHR mode reconstructed with AiCE DLR, relative to the Aquilion ONE GENESIS with AIDR, for Lung Cancer Screening.
Clinical Image Quality	Reconstructed images must be of diagnostic quality.	Representative body, cardiac, and low-dose chest images, as well as images of diseased patients with low contrast and small lesions, were reviewed by an American Board Certified Radiologist. It was confirmed that the reconstructed images using the subject device were of diagnostic quality.

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

Quantitative Spatial Resolution Improvement, Dose Neutral/Equivalent LCD & HC Spatial Resolution, Lung Cancer Screening Image Quality: These studies utilized phantoms, not human patient data. Therefore, the concept of sample size and data provenance (country, retrospective/prospective) related to human data does not apply in the conventional sense. The "sample size" would relate to the number of phantom scans and settings tested. The document does not specify the exact number of phantom scans or specific phantom models.
Clinical Image Quality: "Representative body, cardiac and low dose chest images, as well as images of diseased patients with low contrast and small lesions" were used. The exact number of images/cases (sample size) is not specified. The provenance of this data (country of origin, retrospective or prospective) is not explicitly stated.

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

Noise Texture Reader Study, Quantitative Spatial Resolution Improvement, Dose Neutral/Equivalent LCD & HC Spatial Resolution, Lung Cancer Screening Image Quality: These studies primarily involved quantitative technical metrics derived from phantom scans. Expert assessment of "ground truth" in terms of clinical diagnosis or lesion identification was not the primary method for these bench tests.
Clinical Image Quality: "An American Board Certified Radiologist" reviewed the images to confirm diagnostic quality. This indicates one expert. The specific years of experience or sub-specialization are not stated beyond "American Board Certified."

4. Adjudication Method for the Test Set

Quantitative Bench/Phantom Studies: These studies rely on objective, quantitative measurements (e.g., lp/cm, CNR, SD, NPS, kurtosis values). Adjudication by multiple human readers is not applicable for these metrics.
Clinical Image Quality: The document states that the images were "reviewed by an American Board Certified Radiologist" and "it was confirmed that the reconstructed images using the subject device were of diagnostic quality." This implies a single-reader review, without explicit mention of an adjudication process (e.g., 2+1, 3+1 consensus).

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

No, an MRMC comparative effectiveness study is not explicitly mentioned or described. The document focuses on demonstrating substantial equivalence through technical performance metrics and a single-reader clinical review for diagnostic quality. There is no information provided about human readers improving with or without AI assistance, or any effect size.

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

Yes, the majority of the performance testing described (Image Quality Evaluation, Noise Texture Reader Study, Quantitative Spatial Resolution Improvement, Dose Neutral/Equivalent LCD and High Contrast Spatial Resolution Improvement, Lung Cancer Screening Image Quality) are standalone algorithm performance evaluations. These tests assess the objective image quality characteristics produced by the AiCE algorithm (and FIRST) primarily through phantom studies. The algorithm's output (reconstructed images) is then measured or analyzed.

7. The Type of Ground Truth Used

Quantitative Bench/Phantom Studies: The "ground truth" for these studies is typically based on the known physical properties of the phantoms and the objective measurements derived from them. For example, for spatial resolution, the known line pair patterns in a phantom serve as ground truth for resolution capabilities. For CT number accuracy, the known attenuation properties of materials in the phantom serve as ground truth.
Noise Texture Reader Study: The ground truth for perceptual "naturalness" of noise texture is more subjective but relies on expert consensus in the field regarding what constitutes "natural" CT noise (often referencing FBP). The study used quantitative measures (NPS and kurtosis) to support the claim without explicitly defining a human "ground truth" consensus process.
Clinical Image Quality: The "ground truth" for diagnostic quality in this context is the expert opinion of the American Board Certified Radiologist reviewing the images.

8. The Sample Size for the Training Set

The document states that the "subject device has been retrained to fit for the updated/novel indications." However, the sample size for the training set for the AiCE algorithm is not specified in this document.

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." Deep learning models like AiCE rely on extensive training data. While the document mentions "learning to differentiate structure from noise," it does not explicitly describe how the ground truth for this training data was established. Typically, this would involve large datasets of images (scans) with corresponding "ground truth" images or labels (e.g., ideal noise-free images, images with known anatomical structures, or images reviewed by experts). This information is not provided in the supplied text.

Summary

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September 12, 2022

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 and 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 Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive TUSTIN CA 92780

Re: K220986

Trade/Device Name: Aquilion Precision (TSX-304A/4) V10.10 with AiCE Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: August 9, 2022 Received: August 11, 2022

Dear Orlando 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

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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Laurel Burk Assistant Director Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K220986

Device Name

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

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.

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

Type of Use (Select one or both, as applicable)

	Residential Use (Part 21 CFR 601.2 Subject Drugs)
	Commercial Use (Non-Subject Use)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Made For life

K220986

1. SUBMITTER'S NAME: Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. ESTABLISHMENT REGISTRATION: 9614698

3. OFFICIAL CORRESPONDENT/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:
  March 31, 2022

5. TRADE NAME(S):

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

COMMON NAME: 6.

Computed Tomography X-ray System

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:

JAK

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	Regulation Number	RegulationName	Product Code	510(k)Number	ClearanceDate
Aquilion Precision(TSX-304A/1 and /2)V8.8 with AiCE	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K182901	July 5, 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.

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.

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, and cardiac applications.

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion Precision (TSX-304A/4) V10.10 with AiCE is substantially equivalent to Aquillion Precision (TSX-304A/1 and /2) V8.8 with AiCE, which received premarket clearance under K182901, 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 Aquilion Precision (TSX-304A/4) V10.10 with AiCE includes changes made to the predicate device that expand the use of AiCE to lung/cardiac applications and gantry tilt operability. The subject device has been retrained to fit for the updated/novel indications. A comparison of the technological characteristics between the subject and the predicate device is included below.

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	Subject Device	Predicate Device	Comment
Device Name,Model Number	Aquilion Precision (TSX -304A/4) V10.10 with AiCE	Aquilion Precision (TSX -304A/1 and /2) V8.8 with AiCE
510(k) Number	This submission	K182901
AiCE Modifications
	● Scan Regions	Abdomen and Pelvis / Chest / Cardiac	Abdomen and Pelvis
	● Available ScanTypes	- Helical scan- Volume scan- vHP*	- Helical scan(Not applicable to tilt scans)- Volume scan(Not applicable to W-Volume tilt scans)- vHP*
	● ECG-gated scan	Available in BODY SHARP,LUNG and CARDIAC	N/A
	● Respiratory-gated scan	Available in BODY SHARP,LUNG and CARDIAC	N/A
	● Applicableanatomicalregions	- BODY and BODY SHARP(For Abdomen and Pelvis)- LUNG (For Chest)- CARDIAC (For Cardiac)	- BODY (For Abdomen andPelvis)
	● Image thickness	0.25, 0.5, 1, 2, 3, 4, 5, 7, 8and 10 mm	0.25 and 0.5 mm
	● Magnifiedreconstruction -AvailablemagnificationSize (D-FOV)	BODY / BODY SHARP: Min.100 mmLUNG: Min. 100 mmCARDIAC: Min. 70 mmMax. 500 mm	Min. 100 mmMax. 500 mm
	Gantry tilt	±30°Axial and helical scanning• Tilt scans are applicablewith AiCE BODY SHARP,LUNG and CARDIAC• For BODY parameters,ECG-gated scan,respiratory-gated scan,W-Volume tilt scan andtilt helical scan cannot beapplied	±30°Axial and helical scanning• Helical and W-Volume tiltscans are not applicablewith AiCE

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	Subject Device	Predicate Device
Device Name,Model Number	Aquilion Precision (TSX -304A/4) V10.10 with AiCE	Aquilion Precision (TSX -304A/1 and /2) V8.8 with AiCE
510(k) Number	This submission	K182901
Console	AiCE/FIRST (CCRS-003B) canbe installed in the consoleunit	Separate unit, I-REC BOX, wasused as the AiCE/FIRST (CCRS-002A) server

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, IEC60601-1-2, 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.

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 (SSPz), 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 conditions. AiCE is substantially equivalent to the predicate device as demonstrated by the results of the above testing.

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 claims that AiCE images have a more natural noise texture compared to FIRST images, AiCE noise texture is as natural as filtered backprojection and is distinct from MBIR images.

Quantitative Spatial Resolution Improvement

A spatial resolution comparison study was conducted to support a high contrast spatial resolution improvement claim of 16.5 lp/cm improvement for Body in HR mode, 10.5 lp/cm improvement for Cardiac in HR mode, 15 lp/cm improvement for Lung in HR mode and more than 10 lp/cm improvement across all AiCE available body regions, all compared to hybrid iterative reconstruction with conventional scanning at the same dose.

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Dose Neutral/Equivalent LCD and High Contrast Spatial Resolution Improvement A study was conducted comparing the Aquilion Precision in HR (High Resolution) mode with AiCE Body Sharp and AiCE Cardiac to the Aquilion Precision NR (Normal Resolution) mode with AIDR Body and AIDR Cardiac. Results of the study determined that High Resolution mode with AiCE is dose neutral relative to AIDR normal resolution mode, High Resolution mode with AiCE has equivalent Low Contrast Detectability relative to normal resolution mode and AiCE has equivalent Low Contrast Detectability with 10lp/cm more high contrast spatial resolution for body.

Lung Cancer Screening

CT image quality metrics were performed, utilizing phantoms, relevant to Lung Cancer Screening to assess CT Number Accuracy, Uniformity, Slice Sensitivity Profile (SSP), Modulation Transfer Function (MTF)-Edge, Standard Deviation of Noise (SD) and Noise Power Spectra (NPS). Results demonstrated that equivalent or improved performance for the Aquilion Precision in HR and SHR mode reconstructed with AiCE DLR, relative to the Aquilion ONE GENESIS with AIDR, for Lung Cancer Screening.

Performance Testing - Clinical Images

Representative body, cardiac and low dose chest images, as well as images of diseased patients with low contrast and small lesions, reviewed by an American Board Certified Radiologist, were obtained using the subject device and it was confirmed that the reconstructed images using the subject device were of diagnostic quality.

A summary of the risk analysis and verification/validation testing conducted through bench and clinical testing is included in this submission which demonstrates that the requirements for the system have been met.

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 included in this submission. This documentation includes justification for the Moderate Level of Concern determination as well as testing which demonstrates that the verification and validation requirements for the modifications described above have been met.

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.

17. CONCLUSION

The Aquilion Precision (TSX-304A/4) V10.10 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.