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

Device Description

Aquilion Serve SP (TSX-307B/1) V1.3 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, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

Aquilion Serve SP (TSX-307B/1) V1.3 is equipped with SilverBeam Filter which is a beam shaping filter that leverages the photon-attenuating properties of silver to selectively remove low energy photons from a polychromatic X-ray beam, leaving an energy spectrum optimized for high contrast CT applications.

AI/ML Overview

The provided text is a 510(k) summary for a Computed Tomography (CT) system (Aquilion Serve SP), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for a new AI algorithm's performance against acceptance criteria.

While the document mentions AiCE (Advanced Intelligent Clear-IQ Engine) as a noise reduction algorithm that improves image quality by employing Deep Convolutional Network methods, it does not provide the specifics of the study that proves this particular feature meets acceptance criteria. The performance testing section primarily describes bench testing using phantoms to assess image quality metrics and dose reduction, comparing the new device's overall performance to that of the predicate, not specifically the AI algorithm's standalone or human-in-the-loop performance.

Therefore, many of the requested details about the study proving the device (specifically its AI component, AiCE) meets acceptance criteria cannot be extracted from this text. The acceptance criteria and performance data provided are for the CT system as a whole, mainly from phantom testing.

However, based on the limited information related to performance testing in this 510(k) summary, here's what can be inferred and what is missing:

Acceptance Criteria and Device Performance (Inferred from Bench Testing Section):

The document states: "It was concluded that the performance of TSX-307B (Serve SP) was improved and/or substantially equivalent to the predicate device as demonstrated by the results of the testing." This indicates the general acceptance criterion was "improved and/or substantially equivalent" performance when compared to the predicate device, specifically across various image quality metrics and dose reduction.

Acceptance Criterion (Inferred)	Reported Device Performance (Summary)
Contrast-to-Noise Ratio (CNR)	Improved and/or substantially equivalent to predicate device
CT Number Accuracy	Improved and/or substantially equivalent to predicate device
Uniformity	Improved and/or substantially equivalent to predicate device
Slice Sensitivity Profile (SSP)	Improved and/or substantially equivalent to predicate device
Modulation Transfer Function (MTF)-Wire	Improved and/or substantially equivalent to predicate device
Modulation Transfer Function (MTF)-Edge	Improved and/or substantially equivalent to predicate device
Standard Deviation of Noise (SD)	Improved and/or substantially equivalent to predicate device
Noise Power Spectra (NPS)	Improved and/or substantially equivalent to predicate device
Low Contrast Detectability (LCD)	Improved and/or substantially equivalent to predicate device
Pediatric phantom/protocol performance	Improved and/or substantially equivalent to predicate device
Dose reduction (with SilverBeam Filter / DR-Mode)	Able to achieve dose reduction in both Head and Body modes compared to normal scan mode.

Missing Information (Crucial for AI Algorithm Performance):

The provided text does not contain the detailed information for a clinical study specifically evaluating the AiCE (Advanced Intelligent Clear-IQ Engine) AI algorithm against acceptance criteria. The summary focuses on the overall CT system's substantial equivalence to a predicate.

Therefore, the following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not described for a study specifically on AiCE. The performance testing described is bench testing using phantoms.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set using expert ground truth is described for AiCE.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The focus is on technical equivalence and phantom-based image quality.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document states AiCE improves image quality and reduces noise. This implies a standalone capability for image processing, but no specific study or metrics for this standalone performance (e.g., diagnostic accuracy on a dataset) are detailed. The "bench testing" is related to the overall CT system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any AI-specific performance. The stated "ground truth" for the overall CT system's performance is derived from physical phantom measurements.
The sample size for the training set: Not mentioned. It's only stated that AiCE uses Deep Convolutional Network methods.
How the ground truth for the training set was established: Not mentioned.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of the Aquilion Serve SP CT system to a predicate device, primarily through bench testing using phantoms and comparing general technical specifications. While it mentions the inclusion of an AI-powered noise reduction algorithm (AiCE), the document does not detail specific studies or acceptance criteria for this AI component's performance, either standalone or in a human-in-the-loop setting, which would typically involve clinical data, expert readers, and specific accuracy metrics.

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.

December 6, 2023

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

Re: K233334

Trade/Device Name: Aquilion Serve SP (TSX-307B/1) V1.3 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: September 29, 2023 Received: November 13, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233334

Device Name

Aquilion Serve SP (TSX-307B/1) V1.3

Indications for Use (Describe)

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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K233334 510(k) SUMMARY

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: September 29, 2023
1. TRADE NAME(S): Aquilion Serve SP (TSX-307B/1) V1.3
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	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
Aquilion Serve (TSX-307A/1) V1.3Primary Predicate	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K231281	September19, 2023
Aquilion Prime SP(TSX-303B/8) V10.2with AiCE-iReference Predicate	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K192832	February 21,2020

REASON FOR SUBMISSION: 11.

Modification of a cleared medical device

12. DEVICE DESCRIPTION:

13. INDICATIONS FOR USE:

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion Serve SP (TSX-307B/1) V1.3 is substantially equivalent to Aquilion Serve (TSX-307A/1) V1.3, which received premarket clearance under K231281, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Serve SP is the same as that of the predicate device. The Aquilion Serve SP (TSX-307B/1) V1.3 includes implementation of a 7.5 MHU X-ray tube and the increased X-ray generator output which are identical to the components that received 510(k) clearance as part of the Aquilion Prime SP (TSX-303B/8), K1912832. A comparison of the technological characteristics between the subject and the predicate device is included below.

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	Subject Device	Primary Predicate Device	Reference Predicate Device
Device Name, Model Number	Aquilion Serve SP(TSX-307B/1) V1.3	Aquilion Serve(TSX-307A/1) V1.3	Aquilion Prime SP(TSX-303B/8) V10.2 with AiCE-i
510(k) Number	This submission	K231281	K192832
X-ray generation
Channel-direction (fan) angle	49.2°	49.2°	49.2°
Rated output	Max.72 kW(with Option installed)	Max. 50.4 kW	Max.72 kW(with Option installed)
X-ray tube voltage	80/100/120/135 kV	80/100/120/135 kV	80/100/120/135 kV
X-ray tube current*	10 - 600 mA10 - 500 mA( with Option installed)	10 - 420 mA	10 - 600 mA10 - 500 mA( with Option installed)
X-ray tube heat capacity	7.5 MHU	5.0 MHU	7.5 MHU
X-ray tube cooling rate	Max. 1,386 kHU/min(16.5 kW)Actual 1,008 kHU/min(12.0 kW)	Max. 864 kHU/min	Max. 1,386 kHU/min(16.5 kW)Actual 1,008 kHU/min(12.0 kW)
Focal spots sizes - IEC 60336: 2005, nominal:	Small: 0.9 mm x 0.8 mmLarge: 1.6 mm x 1.4 mm	Small: 0.9 mm x 0.7 mmLarge: 1.4 mm x 1.4 mm	Small: 0.9 mm x 0.8 mmLarge: 1.6 mm x 1.4 mm
X-ray tube inherent filtration	1.0 mm Al equivalent or more	1.0 mm Al equivalent or more	1.0 mm Al equivalent or more
X-ray generator (HFG)	Model: CXXG-012A	Model: CXXG-015A	Model: CXXG-012A

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 IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366-1, 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.

Performance Testing - Bench

Objective 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 performance of TSX-307B (Serve SP) was improved and/or substantially equivalent to the predicate device as demonstrated by the results of the testing.

Dose Reduction Mode (DR-Mode) - SilverBeam

A study was conducted to confirm that Dose Reduction mode (DR-Mode), which uses the SilverBeam Filter, is able to realize dose reduction compared to normal scan mode. Utilizing 160mm and 320 mm dosimetry phantoms, CTDI300 and CTDIw values for Head and Body modes were compared between normal scan mode and DR-Mode. Results of the study demonstrated that DR-Mode (with SilverBeam Filter) is able to achieve dose reduction in both Head and Body modes compared to normal scan mode.

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

Software Documentation for a Basic Documentation Level, per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is included in this submission. This documentation includes justification for the Basic Documentation Level determination as well as testing which demonstrates that the verification and validation requirements 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 Serve SP (TSX-307B/1) V1.3 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