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, usinq 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.

Device Description

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 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 iterative reconstruction technology, FIRST 3.0, intended to reduce exposure dose while maintaining and/or improving image quality.

AI/ML Overview

The provided document describes the Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0, a Computed Tomography (CT) system, and its substantial equivalence to a predicate device. The performance validation focuses heavily on image quality metrics and spatial resolution, particularly for the new HR (High Resolution) and SHR (Super High Resolution) modes and the FIRST 3.0 iterative reconstruction algorithm.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with corresponding performance metrics like a typical study design. Instead, it describes various tests and their outcomes, often in qualitative terms comparing the new device to a predicate or describing improvements. However, we can infer some criteria and their met outcomes:

Metric Category	Acceptance Criteria (Inferred from text)	Reported Device Performance
Image Quality (General)	Demonstrate equivalent or improved image quality compared to the predicate device and FBP reconstruction, across various standard metrics (CT number accuracy, contrast-to-noise ratio, uniformity, slice sensitivity profile, modulation transfer function, low contrast detectability, standard deviation of noise, noise power spectra).	- The Aquilion Precision in NR mode is "substantially equivalent" to the predicate device for CT image quality metrics. - The HR and SHR modes "yield improved high contrast spatial resolution with some tradeoff in noise and LCD relative to NR mode." - The FIRST algorithm "demonstrates equivalent or improved image quality relative to FBP for all modes."
High Contrast Spatial Resolution	Achieve a specific high contrast spatial resolution, particularly with HR mode and FC90 reconstruction.	- A high contrast spatial resolution claim of "up to 46.1 lp/cm based upon the 2% of the MTF of images of a wire test object acquired in HR mode, under the axial scan mode and reconstructed with FC90" is supported initially. - Later, it's stated that "a high contrast spatial resolution claim of up to 49.5 lp/cm, based upon the 2% of the MTF of images of a wire test object acquired in HR mode and reconstructed with FC90, is supported." This suggests an even better performance than initially stated, or a refinement of the measurement.
Low Contrast Detectability (LCD) and Dose	Maintain equivalent or reasonable LCD, and ideally demonstrate dose reduction capabilities with FIRST.	- HR and SHR modes "may result in equivalent or a modest increase in X-ray dose as compared to scanning in normal resolution mode (NR)." - "As demonstrated by the performance of FIRST at reduced mA values for standard deviation, MTF, and visual LCD as compared to FBP at higher mA values a qualitative claim of Dose Reduction with FIRST is supported." - A study on Head and Body MITA-FDA LCD phantoms established baseline LCD (AUC) values and indicated potential trade-offs.
Size Discrimination	Demonstrate improved size discrimination.	- A 50% improvement in size discrimination was observed with High Resolution mode compared to Normal Resolution mode at the same dose, using Catphan 10HU contrast rods (4-9mm diameter) in a model observer study.
Diagnostic Quality	Produce images of diagnostic quality across various anatomical regions.	- "Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended."
Substantial Equivalence	Demonstrate substantial equivalence to the predicate device.	- "The Aquilion Precision in NR mode is substantially equivalent to the predicate device." - "NR mode and predicate device images were substantially equivalent."

2. Sample Size used for the test set and the data provenance:

The document does not explicitly state sample sizes for all tests.

Spatial Resolution Confirmation: "the MTF results of seven Aquilion Precision systems" were measured. This is a sample size of 7 systems, likely involving phantom data.
Low Contrast Detectability: "Head and Body MITA-FDA LCD phantoms" were utilized. The number of phantoms or scans is not specified.
Size Discrimination Performance: "Catphan 10HU contrast rods, 4-9mm in diameter" were used. The number of scans or virtual phantoms is not specified.
Cadaver and Cardiac Stent Images: "cadaver and cardiac stent images" were provided. The number of cadavers or stents is not specified.
Diagnostic Quality Images: "Representative diagnostic images... including head, chest, abdomen/pelvis, extremity and cardiac exams" were obtained. The number of cases is not specified.

Data Provenance: Primarily phantom data and some cadaver/stent images appear to be used for the technical performance assessments. The diagnostic quality images were "obtained using the subject device," implying prospective acquisition for the purpose of this submission rather than retrospective data. The location of data acquisition (country of origin) is not specified, but the submission is by Toshiba Medical Systems Corporation, Japan, and Toshiba America Medical Systems, Inc., USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Diagnostic Quality Images: "Representative diagnostic images, reviewed by an American Board Certified Radiologist."
- Number of Experts: Singular, "an American Board Certified Radiologist" (implying one).
- Qualifications: "American Board Certified Radiologist." No specific experience level is mentioned (e.g., 10 years of experience).
For the phantom-based studies (spatial resolution, LCD, size discrimination), the "ground truth" is typically inherent in the phantom design and physical measurements, rather than established by human experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

For the diagnostic quality image review by "an American Board Certified Radiologist," no adjudication method is mentioned, implying it was a single reader assessment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study involving human readers and AI assistance (FIRST 3.0) is described. The studies primarily focus on the objective image quality metrics of the device itself and its reconstruction algorithms. The "model observer study" for size discrimination is a computational model, not human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the majority of the image quality evaluations (CT number accuracy, contrast-to-noise ratio, uniformity, slice sensitivity profile, MTF, LCD, etc.) of the FIRST 3.0 algorithm and the new acquisition modes (HR, SHR) are "standalone" performance evaluations. They assess the inherent image characteristics produced by the system and its algorithms using phantoms, independent of a human observer's interpretation in a clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Phantom-based studies: The ground truth is the known properties of the phantoms (e.g., known dimensions of rods, known contrast differences, known noise levels).
Diagnostic Quality Images: The ground truth for this qualitative assessment is the subjective expert opinion of "an American Board Certified Radiologist" that the images are of "diagnostic quality." This is a form of expert opinion, but not "consensus" as only one expert is mentioned.
No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set:

The document does not provide any information about the training set or its sample size. This is typical for submissions focused on the hardware and reconstruction algorithms of a CT scanner, where the "training" (if applicable for AI components) would be part of the algorithm development process, not usually detailed in a 510(k) summary for hardware clearance unless the AI itself is the primary new component. FIRST 3.0 is an iterative reconstruction algorithm, which generally relies on mathematical models and image processing, not necessarily on "training data" in the machine learning sense to learn to identify specific pathologies.

9. How the ground truth for the training set was established:

Not applicable, as no information on a training set or its ground truth establishment is provided.

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 and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

Toshiba Medical Systems Corporation % Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive TUSTIN CA 92780

February 23, 2018

Re: K173468

Trade/Device Name: Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 10, 2018 Received: January 11, 2018

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173468

Device Name

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

Indications for Use (Describe)

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

ك Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

1. SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
OFFICIAL CORRESPONDENT: 2. Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
1. ESTABLISHMENT REGISTRATION: 9614698

4. CONTACT PERSON:

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

ട. Date Prepared:

February 20, 2018

6. TRADE NAME(S):

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

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]

Image /page/3/Picture/20 description: The image shows the Canon logo in red, with the words "CANON GROUP" in black below it. The words "Page 1 of 6" are located in the bottom left corner of the image. The logo and text are crisp and clear against a white background.

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11. PREDICATE DEVICE:

Product	Marketed		Regulation Regulation	Product Code	510(k)	Clearance
	by	Number	Name		Number	Date
Aquilion PRIME,TSX-303A/A, /B and /F,v6.00(Primary PredicateDevice)	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K141741	11/11/2014
Aquilion ONE (TSX-305A/3) V8.3 withFIRST 2.1	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K170177	06/30/2017

12. REASON FOR SUBMISSION:

New 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.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0, is substantially equivalent to the Aquilion PRIME, TSX-303A/A, /B and /F v6.00, which received premarket clearance under K141741 and is marketed by Toshiba America Medical Systems. The intended use of the Aquilion Precision is the same as that of the predicate device. Software applications that have already received 510(k) clearance are being implemented on the subject device. The main difference between the Aquilion Precision and the predicate device is the configuration of the detector as well as the implementation of two new acquisition modes, HR (High Resolution) and

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SHR (Super High Resolution), in addition to the conventional, NR (Normal Resolution) mode, which provides the user with image quality improvements. The NR mode is substantially equivalent to the acquisition mode employed by the predicate device. A comparison of the technological characteristics between the subject and the predicate device is included below.

ltem	Aquilion Precision (TSX-304A/2)V8.6 with FIRST 3.0	Aquilion PRIME, TSX-303A/A, /Band /F v6.00
510(k) Number	This submission	K141741
Configuration of the detector	0.25 mm x 160 rows	0.5 mm x 80 rows
Detector	1792 channels × 160 rows	896 channels × 80 rows
Max. scan length/rotation	40 mm/rotation	40 mm/rotation
Acquisition Modes	NR mode:
	0.5mm x 80 rows / 896 channels	0.5mm x80 rows /896 channels
	HR mode:
	0.5mm x 80 rows /1792 channels
	SHR mode:
	0.25mm x 160 rows /1792channels
Reconstruction Matrix	NR mode: 512×512	512 x 512
	HR & SHR mode: 512×512, 1024×1024
FOV (field of view)	320/500mm in diameter	180/240/320/400/500 mm indiameter
Wedge filter Types	Three types	Three types
	Small1:FOV M	Small :FOV SS, S
	Large1:FOV L	Medium :FOV M
	Large2:FOV L	Large :FOV L, LL
X-ray tube capacity	5.7 MHU	7.5 MHU
Maximum tube cooling rate	1,026 kHU/min	1,386 kHU/min
Continuous tube cooling rate	660 kHU/min	1,008 kHU/min
Focal spots size	Small: Two types	Small: One type
	Large: Four types	Large: One type
CPU memory	256 Gbyte or more	12 Gbyte or more
Image reconstruction time	Up to 80 images/s	Up to 30 images/s (0.033 s/image)
(Max. speed)	(0.0125 s/image)	Option:
		Up to 60 images/s (0.017 s/image)
Magnetic disk	9.8 TB or more	915 GB or more
	Raw data: 4,000 rotations or more	Raw data: 4000 rotations
		Image data: 500,000 images
Item	Aquilion Precision (TSX-304A/2)V8.6 with FIRST 3.0	Aquilion PRIME, TSX-303A/A, /Band /F v6.00
510(k) Number	This submission	K141741
BD-RE(Blu-ray Disc)	Image data: 2,000,000 images ormore (1024 x 1024 pixel images)	N/A
	25 GBImage data:10,000 images (1024 x1024 pixel images)
Noise reduction processing	AIDR 3DAIDR3D Enhanced	QDSAIDR 3DAIDR3D Enhanced
Metal artifact reduction	SEMAR(Volume, Helical)SEMAR (ECG gated)	SEMAR(Volume, Helical)SEMAR (ECG gated)
Gantry opening size	780 mm in diameter	780 mm in diameter
Tilt angle	$\pm$ 30°	$\pm$ 30°
Patient Couch
Vertical movement:	2050mm	2390mm
Couch top stroke	1750mm	1890mm
Frame slide stroke	330mm	N/A
Scan permissible range:	2000mm	2000mm
Conventional	1700mm	1500mm
Scan permissible range:	1950mm	1950mm
Helical	1650mm	1450mm
Couch-top Speed ofmovement (fast)	200mm/s	200mm/s
Vertical movement stroke	520mm	568mm
Couch-top width	470mm	470mm
Lowest couch height	420mm	332mm
Max. guaranteed weight	300kg	300kg
Footswitch	Standard	Standard
Lateral movement unit	Optional	Optional
Movement speed	20mm/s	10mm/s
Lateral Stroke (right andleft)	170mm (85mm in the lateraldirection)	84mm (42mm in the lateraldirection)
FIRST 3.0	Optional	N/A

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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, IEC60601-1-3, 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 CT number accuracy, contrast-to noise ratio, uniformity, slice sensitivity profile, modulation transfer function, low contrast detectability, standard deviation of noise and noise power spectra. The Aquilion Precision in NR mode is substantially equivalent to the predicate device. The HR and SHR modes yield improved high contrast spatial resolution with some tradeoff in noise and LCD relative to NR mode. The FIRST algorithm demonstrates equivalent or improved image quality relative to FBP for all modes. A high contrast spatial resolution claim of "up to 46.1 lp/cm based upon the 2% of the MTF of images of a wire test object acquired in HR mode, under the axial scan mode and reconstructed with FC90" is supported. As demonstrated by the performance of FIRST at reduced mA values for standard deviation, MTF, and visual LCD as compared to FBP at higher mA values a qualitative claim of Dose Reduction with FIRST is supported.

Confirmation of Spatial Resolution

The spatial resolution claim was confirmed by measuring the MTF results of seven Aquilion Precision systems. It was determined that a high contrast spatial resolution claim of up to 49.5 lp/cm, based upon the 2% of the MTF of images of a wire test object acquired in HR mode and reconstructed with FC90, is supported.

Low Contrast Detectability Equivalence in Normal Resolution vs High Resolution Modes

A study was conducted utilizing the Head and Body MITA-FDA LCD phantoms to establish a baseline LCD value (AUC) in Normal Resolution (NR) mode using a protocol based on Toshiba's standard adult abdomen protocol and standard adult head protocol, with a fixed technique at a clinically realistic CTDI, and reconstructed with Filtered Backprojection (FBP), AIDR Enhanced, and FIRST. Results of the study demonstrated that scanning in high resolution mode (HR) and in super high resolution mode (SHR) may result in equivalent or a modest increase in Xray dose as compared to scanning in normal resolution mode (NR).

Size Discrimination Performance

A model observer study was conducted comparing detectability of a 0.5 mm change in object radius in Normal Resolution vs High Resolution mode utilizing the Catphan 10HU contrast rods, 4-9mm in diameter, which demonstrated a 50% improvement in size discrimination with High Resolution mode compared to Normal Resolution mode at the same dose.

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Alternatives to clinical images of cardiac and extremities using cardiac stent and cadaver A study was conducted to provide cadaver and cardiac stent images for certain anatomical regions in lieu of sample clinical images acquired in NR and HR mode since these examples were not available. This study demonstrated that NR mode and predicate device images were substantially equivalent and that the images acquired in HR and SHR modes showed improved spatial resolution as compared to images acquired in NR mode.

Representative diagnostic images, reviewed by an American Board Certified Radiologist, including head, chest, abdomen/pelvis, extremity and cardiac exams were also obtained using the subject device which demonstrates that the device produces images of diagnostic quality and; therefore, performs as intended.

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/2) V8.6 with FIRST 3.0 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.