This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve has the capability to provide 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 Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

Device Description

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (Advanced intelligent Clear-IQ Engine-integrated) 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

The provided text describes the regulatory clearance of the Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i, a Computed Tomography X-ray System, by the FDA. The submission outlines comparisons to a predicate device and various performance tests. However, the document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal study with acceptance criteria and a detailed breakdown of results for a specific performance claim of the device's AI component (AiCE) in improving human reader performance.

Several key pieces of information requested, particularly regarding clinical studies focused on AI's impact on human readers, are not explicitly present in the provided text. The document describes technical performance comparisons of the AiCE algorithm (noise reduction, image quality metrics) and clinical verification of diagnostic quality, but not a multi-reader multi-case (MRMC) study on human performance with and without AiCE assistance.

Therefore, the following response will extract the information available and indicate where the requested information is not provided in the supplied text.

Acceptance Criteria and Study Proving Device Meets Criteria

The primary objective of this submission is to demonstrate substantial equivalence of the Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i to a predicate device (Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i). The "acceptance criteria" can therefore be inferred as demonstrating equivalent or improved performance in various image quality metrics and functional aspects compared to the predicate device, or demonstrating image quality that is diagnostically acceptable. There is no specific acceptance criteria table provided in the context of an "AI effect" on reader performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As there isn't a single "AI acceptance criteria" table for human performance, the table below summarizes the objective image quality performance comparisons the manufacturer conducted to support their claims about AiCE. The "acceptance criteria" is implicitly "equivalent or improved performance" compared to the baseline (FBP, AIDR 3D, or predicate device).

Acceptance Criteria (Implicit for AiCE)	Reported Device Performance (Relative to FBP/AIDR 3D or Predicate)
Objective IQ Performance Comparison (TSX-307A vs. Predicate)
Contrast-to-Noise Ratios (CNR)	Equivalent or improved performance
CT Number Accuracy	Equivalent or improved performance
Uniformity	Equivalent or improved performance
Slice Sensitivity Profile (SSP)	Equivalent or improved performance
Modulation Transfer Function (MTF)-Wire	Equivalent or improved performance
Standard Deviation of Noise (SD)	Equivalent or improved performance
Noise Power Spectra (NPS)	Equivalent or improved performance
Low Contrast Detectability (LCD)	Equivalent or improved performance
Image Quality Metric Evaluation (AiCE vs. FBP/AIDR 3D)
CNR	Equivalent or improved image quality performance
CT Number Accuracy	Equivalent or improved image quality performance
Uniformity	Equivalent or improved image quality performance
SSP	Equivalent or improved image quality performance
MTF-Wire	Equivalent or improved image quality performance
MTF-Edge	Equivalent or improved image quality performance
SD of Noise	Equivalent or improved image quality performance
NPS	Equivalent or improved image quality performance
LCD	Equivalent or improved image quality performance
Pediatric	Equivalent or improved image quality performance
AiCE for Lung Cancer Screening IQ Evaluation
CNR	Equivalent or improved performance
CT Number Accuracy	Equivalent or improved performance
Uniformity	Equivalent or improved performance
SSP	Equivalent or improved performance
MTF-Edge	Equivalent or improved performance
SD of Noise	Equivalent or improved performance
NPS	Equivalent or improved performance
Noise Texture
Natural noise texture	More natural than FIRST, as natural as FBP, distinct from MBIR
Quantitative Spatial Resolution
High contrast spatial resolution	Twice the high contrast spatial resolution for AiCE Body (10% MTF)
	4.1 lp/cm increase for AiCE Cardiac (10% MTF) vs. AIDR
Quantitative Body LCD and Noise Improvement / Dose Reduction
Low contrast detectability	Improved LCD at same dose for AiCE Body vs. AIDR
Noise reduction	Noise reduction with AiCE at same dose for body vs. AIDR
Dose reduction	Dose reduction for AiCE Abdomen relative to FBP
Low Contrast Detectability Evaluation
Low contrast detectability	8.8 mGy (0.3%/3 mm) for AIDR3D; 15.9mGy (0.3%/2mm) & 8.1mGy (0.3%/3mm) for AiCE
Clinical Image Assessment
Diagnostic Quality	Confirmed diagnostic quality of reconstructed images

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

Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of number of patient cases for the clinical image review. It mentions "Representative body, cardiac, chest, head, and extremity diagnostic images." For phantom studies, specific phantom types (e.g., MITA - FDA LCD Body phantom, 24cm and 32cm water phantoms) are mentioned but not a "sample size" in terms of repeated measurements, though implied through quantitative reporting.
Data Provenance: Not explicitly stated. The document refers to "volunteer assessment" for automatic scan planning and "clinical images" for diagnostic quality review. The location (country of origin), and whether the data was retrospective or prospective, are not provided.

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

Number of Experts: For the clinical image review, the document states "reviewed by an American Board-Certified Radiologist." This implies a single expert.
Qualifications of Experts: "American Board-Certified Radiologist". No mention of years of experience.

4. Adjudication Method for the Test Set

For the "clinical images," it states "reviewed by an American Board-Certified Radiologist," indicating a single reader, so no adjudication method is described or implied.
For phantom studies, the ground truth is objective measurements (e.g., from phantoms), not requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is described in the provided text. The document focuses on technical image quality metrics and a single radiologist's review of diagnostic quality, not a comparative study showing human readers' improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was assessed for the AiCE algorithm through various phantom and objective image quality metric evaluations (e.g., CNR, MTF, NPS, LCD, noise reduction claims). These evaluate the algorithm's output (image quality characteristics) without human interpretation in the loop.

7. Type of Ground Truth Used

Phantom-based objective ground truth: For most image quality metrics (CNR, CT number accuracy, uniformity, SSP, MTF, SD, NPS, LCD, spatial resolution, dose reduction claims), physical phantoms were used, and the "ground truth" was derived from objective measurements on these phantoms.
Expert Consensus/Pathology/Outcomes Data:
- For the "Clinical Images" evaluation, the ground truth was the subjective assessment of diagnostic quality by a single American Board-Certified Radiologist. This is a form of expert assessment, though not explicitly a "consensus" by multiple experts.
- No pathology or outcomes data is mentioned as ground truth in this submission for the AI (AiCE) component.

8. Sample Size for the Training Set

Not provided. The document states that AiCE uses "Deep Convolutional Neural Network methods," implying a training phase, but gives no details on the training dataset size.

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

Not provided. The document does not detail how the ground truth for the training data used by the Deep Convolutional Neural Network (AiCE) was established. This information would typically be found in more detailed technical specifications or a different section of a submission.

Summary

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March 3, 2023

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

Re: K222819

Trade/Device Name: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: February 1, 2023 Received: February 2, 2023

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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of 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)

K222819

Device Name

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

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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510(k) SUMMARY

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 16, 2022
1. TRADE NAME(S): Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

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	Regulation Name	Product Code	510(k) Number	Clearance Date
Primary Predicate:Aquilion Lightning(TSX-036A/7) V10.2with AiCE-i	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K201836	01/12/2021
Reference Predicate:Aquilion Prime SP(TSX-303B/8) V10.2with AiCE-i	CanonMedicalSystems, USA	21 CFR§892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K192832	02/21/2020

11. REASON FOR SUBMISSION:

New 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 Serve 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 (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

14. SUBSTANTIAL EQUIVALENCE:

The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is substantially equivalent to Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i, which received premarket clearance under K201836, and is marketed by Canon Medical Systems USA. The intended use of the Aquilion Serve is the same as that of the predicate device.

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 Serve(TSX-307A/1) V1.2 with AiCE-i	Aquilion Lightning(TSX-036A/7) V10.2 with AiCE-i
510(k) Number	This submission	K201836
Scan modes	Conventional scan (Axial Scan*)Volume, Dynamic volume scanHelical scan	Conventional scan (S&S, S&V)Volume, Dynamic volume scanHelical scan	*: S&V is notsupportedS&S is called"Axial Scan"
	Subject Device	Predicate Device	Comment
Device Name,Model Number	Aquilion Serve(TSX-307A/1) V1.2 with AiCE-i	Aquilion Lightning(TSX-036A/7) V10.2 with AiCE-i
510(k) Number	This submission	K201836
Positioning Scan	Positioning:Single	Scanoscopy:Scano
	Dual3D Landmark Scan	Dual Scano
3D Landmark Scan	Available	Not Available
AnatomicalLandmarkDetection	Available	Not Available
Scan planning assistfunction*	Available	Not Available	*: If 3D LandmarkScan is set in ascan protocol.
Scan slice thickness	[Conventional scan (Axial scan)]4-row scan: 0.5, 1, 2, 3, 4, 5, 8mm1-row scan: 1 mm[Volume, Dynamic volume scan](80-row scan: 0.5 mm)40-row scan: 0.5 mm[Helical scan](80-row scan: 0.5 mm)40-row scan: 0.5 mm and 1 mm20-row scan: 0.5 mm4-row scan: 0.5 mm[3D Landmark Scan]40-row scan: 1.0 mm	[Conventional scan (S&S, S&V)]4-row scan: 0.5, 1, 2, 3, 4, 5, 8,10 mm1-row scan: 1 mm[Volume, Dynamic volume scan](80-row scan: 0.5 mm)40-row scan: 0.5 mm and 1 mm4-row scan: 8 mm and 10 mm[Helical scan](80-row scan: 0.5 mm)40-row scan: 0.5 mm and 1 mm20-row scan: 0.5 mm and 1 mm4-row scan: 0.5 mm	scan protocol.*: Option
Imagereconstruction time	Up to 30 images/s with AIDR 3D(0.033 s/image)Up to 50 images/s with AIDR 3D(0.02 s/image)1Up to 70 images/s with AIDR 3D(0.014 s/image)2Up to 100 images/s with AIDR 3D(0.01 s/image) *3(Depending on the scan andreconstruction conditions)	Up to 20 images/s with AIDR 3D(0.05 s/image)Up to 50 images/s with AIDR 3D(0.02 s/image) *2(Depending on the scan andreconstruction conditions)	1: When the Fastscan kit (CGS-041A) is installed.2: OptionWhen the FastImageReconstruction kit(CCFR-010A) isinstalled.*3: When the FastImageReconstruction kit(CCFR-010A) andthe Fast scan kit(CGS-041A) areinstalled.
Flex e-Tilt	Available	Not Available
	Subject Device	Predicate Device	Comment
Device Name,Model Number	Aquilion Serve(TSX-307A/1) V1.2 with AiCE-i	Aquilion Lightning(TSX-036A/7) V10.2 with AiCE-i
510(k) Number	This submission	K201836
Gantry openingdiameter (aperture)	800 mm in diameter	780 mm in diameter
Wedge filter types	Three (3) types- Small- Large- SilverBeam Filter*	Two (2) types- Small- Large	*Previouslycleared underK213504(TSX-306A)
Gantry internalcameras	Available	Not Available	Two camerasmounted insidethe system at a90-degree phasedifference.
Reconstructionfunctions	Identified as anatomical regions*	Identified as numberedfunctions	*Previouslycleared underK213504(TSX-306A)
Noise reductionprocessing	Adaptive Iterative DoseReduction 3D (AIDR 3D)	Adaptive Iterative DoseReduction 3D (AIDR 3D)
	AIDR 3D Enhanced	AIDR 3D Enhanced
	Advanced Intelligent Clear-IQEngine (AiCE)	Advanced Intelligent Clear-IQEngine (AiCE)
		Quantum Denoising Software(QDS)
NewUX Console*	Available	Not Available	*Previouslycleared underK213504(TSX-306A)
Display monitor	27 inch (3840 x 2160)	19 inch (1280 x 1024)
User Input	Keyboard and Control Pad(Performs scan operation andcontrols voice messages)	Scan Keyboard
Data processor	CPU : 64-bitMemory size: 64 Gbyte or more	CPU : 64-bitMemory size: 32 Gbyte or more
Window width/level	Controlled and continuouslyvariable using the mouse	Controlled and continuouslyvariable using a speed-sensitiverotary encoder
Preset windows	1/image	3/image
Window types	Linear only	Linear and non-linear (6 user-programmable), and doublewindows
ROI shape available	Point, Circular	Point, square, free-form,circular, polygon

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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.

Performance Testing - Bench

Objective IQ Performance Comparison

An image quality metric evaluation comparing performance of the TSX-307A (Aquillon Serve) system relative to the predicate device was conducted. In order to compare the image quality between these two systems, the following image quality performance tests were conducted. It was concluded that the subject device demonstrated equivalent or improved performance, compared to the predicate device, as demonstrated by the results of the above testing.

1. Contrast-to-Noise Ratios (CNR)
1. CT Number Accuracy
1. Uniformity
Slice Sensitivity Profile (SSP) 4.
1. Modulation Transfer Function (MTF)-Wire
1. Standard Deviation of Noise (SD)
1. Noise Power Spectra (NPS)
1. Low Contrast Detectability (LCD)

Image Quality Metric Evaluation

An image quality metric evaluation of Aquilion Serve (TSX-307A/1) V1.2 reconstructed with AiCE, for the available Body, Body Sharp, Lung, Bone, Inner ear, Brain LCD, Brain CTA and Cardiac modes was conducted and equivalent or improved image quality performance relative to FBP and AIDR 3D was demonstrated. The following image quality performance tests were conducted: 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), Pediatric.

AiCE Reconstruction for Lung Cancer Screening Image Quality Metric Evaluation The performance of the subject device (Aquilion Serve with AiCE) was compared to the results for the Aquilion ONE / GENESIS Edition with the AAPM lung cancer screening protocol for both a small and a larger sized phantom. Please note the AAPM protocol

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does not use a fixed mA, but rather an automatic exposure setting of 20HU. Therefore, the dose for the predicate device was determined by first establishing the AECpredicated dose for each phantom and then scanning with a fixed technique on the GENESIS based on the result. The nearest fixed technique on the Serve was then scanned. All results were reconstructed with AIDR (FC18 and FC52) as prescribed by the AAPM protocol and were also reconstructed with AiCE DLR Body Sharp and AiCE Lung and FBP FC18.

In order to compare the image quality between AiCE DLR on the Aquilion Serve and Aquilion ONE / GENESIS Edition with AIDR (AAPM protocol), the following image quality performance tests were conducted:

Contrast-to-Noise Ratios (CNR) 1.
1. CT Number Accuracy
ന് Uniformity
1. Slice Sensitivity Profile (SSP)
1. Modulation Transfer Function (MTF)-Edge
1. Standard Deviation of Noise (SD)
1. Noise Power Spectra (NPS)

It was concluded that the subject device demonstrated equivalent or improved performance as demonstrated by the results of the above testing.

Automatic Scan Planning

Volunteer assessment demonstrated that couch movement appropriately positioned volunteers to the selected anatomical region.

Flex e-Tilt

Image comparison studies were conducted between Flex e-Tilt reconstructed images with the Aquilion Serve versus conventional tilt and MPR (oblique) images utilizing the predicate device, Aquilion Lightning. It was determined that the images were equivalent and there were no significant differences observed.

Noise Texture

An analysis of the NPS and kurtosis values for FBP, FIRST and AiCE was conducted and the results of the study support the following claims, more natural noise texture compared to FIRST, noise texture as natural as filtered backprojection, and noise texture distinct from MBIR.

Quantitative Spatial Resolution

A comparison study was conducted, utilizing phantoms, in order to support a quantitative spatial resolution improvement claim of twice the high contrast spatial resolution for AiCE Body at 10% MTF and a 4.1 lp/cm increase in high contrast spatial resolution for AiCE Cardiac at 10% MTF as compared to AIDR reconstruction.

Quantitative Body LCD and Noise Improvement and Dose Reduction

A phantom study was conducted using the MITA - FDA LCD Body phantom and the results demonstrated improved low contrast detectability at the same dose for AiCE body compared to AIDR, noise reduction with AiCE at the same dose for body compared to AIDR and dose reduction for AiCE Abdomen relative to FBP.

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3D Scano Water Equivalence

A comparison phantom study was conducted utilizing a 24cm and 32cm water phantom to demonstrate that both 3D Scano and dual scano produced 24cm and 32cm water equivalent diameters with less than 5% mean absolute error.

Low Contrast Detectability Evaluation

A phantom study was conducted in order to support claims of low-contrast detectability of 8.8 mGy (0.3%/3 mm) of AIDR3D, and 15.9mGv (0.3% / 2mm) and 8.1mGv (0.3% / 3mm) of AiCE, respectively.

Performance Testing – Clinical Images

Representative body, cardiac, chest, head, and extremity diagnostic images, 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.

A Software Information Checklist is included at the conclusion of this Executive Summary.

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 (TSX-307A/1) V1.2 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.