This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to imaqe whole orqans in a sinqle rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire orqan. These volume sets can be used to perform specialized studies, usinq indicated software/hardware, of the whole organ by a trained and qualified physician.

FIRST 2.0 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

Device Description

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 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 Toshiba CT systems. In addition, the subject device incorporates the latest iterative reconstruction technology, FIRST 2.0, intended to reduce exposure dose while maintaining and/or improving image quality.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Computed Tomography (CT) system named Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4. The documentation focuses on demonstrating substantial equivalence to a predicate device (Aquilion ONE Vision with FIRST 1.0) by updating an iterative reconstruction algorithm (FIRST 2.0).

Based on the provided document, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail table format for clinical performance. Instead, it describes performance in terms of improvements or equivalency compared to the predicate device and filtered back projection (FBP).

Acceptance Criteria Category	Reported Device Performance (Highlights)
Quantitative Dose Reduction	Achieved up to 84.6% dose reduction with 60% noise reduction compared to filtered back projection (FBP). A model observer evaluation showed equivalent low contrast detectability to FBP (range from 0.6 - 0.686) can be achieved with 71.4% to 84.6% less dose using FIRST 2.0 at Standard setting for thin (0.5 mm) reconstruction slice thickness in simulated body phantom. CTDIvol values for low-contrast object identification were improved with FIRST 2.0 vs. FBP and AIDR 3D.
Image Quality (General)	Maintained and/or improved image quality compared to FBP. Improved spatial resolution over FBP.
Image Quality Metrics	Demonstrated that the subject device is substantially equivalent to or demonstrates an improvement to the predicate device with regard to: - Contrast-to-noise ratio - CT number accuracy - Uniformity - Slice sensitivity profile - Modulation transfer function - Line pair gauge - Low contrast detectability - Standard deviation of noise - Noise power spectra.
Diagnostic Quality	Representative diagnostic images reviewed by an American Board Certified Radiologist demonstrated that the device produces images of diagnostic quality and performs as intended.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document mentions "Representative diagnostic images... including chest, abdomen and pelvis, extremity and cardiac exams." However, it does not specify the number of images or cases used for this review.
Data Provenance: The document implies the data was collected from the device itself ("obtained using the subject device"). There is no information about the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket submission for a new version of an existing device, it's likely part of internal validation testing.

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

Number of Experts: "an American Board Certified Radiologist" – indicates one expert was used.
Qualifications: "American Board Certified Radiologist" – this implies a board certification, which generally requires specific training, residency, and passing board examinations, demonstrating a certain level of expertise in radiology. The document does not specify the years of experience of this radiologist.

4. Adjudication method for the test set

Since only one radiologist was used for the diagnostic image review, an adjudication method (like 2+1 or 3+1) was not applicable/performed. The single expert's review served as the 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 study was mentioned or performed as part of this submission. The evaluation was primarily focused on technical image quality metrics and a single radiologist's review of diagnostic image quality, not the impact on human reader performance with or without AI assistance. The "AI" here (FIRST 2.0) is an iterative reconstruction algorithm, which enhances image quality/dose reduction, rather than an AI-driven diagnostic aid that would typically warrant a comparative reader study.

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

Yes, an algorithm-only (standalone) performance evaluation was done in terms of quantitative image quality metrics (e.g., contrast-to-noise ratio, spatial resolution, dose reduction claims) using phantoms.
"A model observer evaluation" directly assessed the algorithm's performance in achieving "equivalent low contrast detectability" with reduced dose, which is a standalone assessment of the algorithm's output.

7. The type of ground truth used

For quantitative image quality metrics and dose reduction claims: Phantoms (e.g., MITA-FDA phantom) were used to provide a known, controlled ground truth.
For diagnostic image quality review: The "ground truth" was established by the expert opinion of an American Board Certified Radiologist who reviewed representative images for "diagnostic quality." This is essentially expert consensus (albeit from a single expert).

8. The sample size for the training set

The document does not provide any information about the sample size used for training the FIRST 2.0 iterative reconstruction algorithm. This information is typically proprietary to the manufacturer and not required in this level of 510(k) summary.

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

The document does not provide any information on how the ground truth for the training set (if any, as iterative reconstruction algorithms might use phantoms or specific patient data for training their models without needing human-labeled "ground truth" for diagnosis) was established. This detail is also not typically shared in a 510(k) summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 22, 2016

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

Re: K161009

Trade/Device Name: Aquilion One Vision with First 2.0 (CCRS-001B) V7.4 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 15, 2016 Received: June 16, 2016

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael 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)

K161009

Device Name

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B)V7.4

Indications for Use (Describe)

FIRST 2.0 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

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)

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FOR FDA USE ONLY

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

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TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

1. SUBMITTER'S NAME:

Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

2. OFFICIAL CORRESPONDENT:

Akinori Hatanaka Senior Manager, Regulatory Affairs and Vigilance

3. 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

5. Date Prepared:

April 8, 2016

6. TRADE NAME(S):

Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4

7. COMMON NAME:

System, X-ray, Computed Tomography

8. 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]

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11. PREDICATE DEVICE:

Product	Marketed by	RegulationNumber	RegulationName	Product Code	510(k)Number	ClearanceDate
AquilionONE Visionwith FIRST1.0 (CCRS-001A)	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K151673	11/27/2015

12. REASON FOR SUBMISSION:

Modification of an existing 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, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc.

The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

FIRST 2.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac and extremities applications.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, is substantially equivalent to the Aquilion ONE Vision with FIRST 1.0 (CCRS-001A), that received premarket clearance under K151673 and is marketed by Toshiba America Medical Systems. The changes made to the subject device include the addition of FIRST 2.0, CCRS-001B, an iterative reconstruction algorithm that allows the exposure dose to be reduced while maintaining and/or improving image quality as seen when using FBP (filtered back projection) and improves spatial resolution over FBP. A comparison of the technological characteristics between the subject and the predicate devices is included below.

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Item	Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4	Aquilion ONE with FIRST 1.0 (CCRS-001A)
510(k) Number	This submission	K151673
Anatomical Region	Abdomen, pelvis, chest, cardiac and extremities	Chest (excluding cardiac), abdomen and pelvis
Exposure Dose Reduction	AIDR 3DFIRST 2.0	AIDR 3DFIRST 1.0
Quantitative Dose ReductionClaim	Yes	Yes
Image Quality Claim	Improved Spatial Resolution overFiltered Back Projection	Improved Spatial Resolution overFiltered Back Projection

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 IEC60601-1-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-2-28, IEC60601-2-32, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25 and NEMA XR-26. 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 are included in this submission which demonstrates that the established specifications for the device have been met.

Image Quality Evaluation

CT image quality metrics were performed, utilizing phantoms, which demonstrated that the subject device is substantially equivalent to or demonstrates an improvement to the predicate device with regard to contrast-to noise ratio, CT number accuracy, uniformity, slice sensitivity profile, modulation transfer function, line pair gauge, low contrast detectability, standard deviation of noise and noise power spectra.

Quantitative Dose Reduction/Spatial Resolution Evaluations

The subject device demonstrated a dose reduction claim of up to 84.6% with 60% noise reduction compared to filtered back projection. A model observer evaluation showed that equivalent low contrast detectability to FBP (range from 0.6 - 0.686) can be achieved with 71.4% to 84.6% less dose using FIRST2.0 at Standard setting for thin (0.5 mm) reconstruction slice thickness in simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it).

Low Contrast Detectability

Evaluations were conducted to measure low-contrast detectability using Aquilion ONE Vision CT systems with current detector (CDAS-052A/3) and previous detector (CDAS-052A/2) configurations. It was concluded that CTDIvol values at which the low-contrast object can be identified were improved with the use of FIRST 2.0 as compared to filtered back projection and AIDR 3D.

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Representative diagnostic images, reviewed by an American Board Certified Radiologist, including chest, abdomen and 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.

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 ONE Vision with FIRST 2.0 (CCRS-001B) V7.4, 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 is substantially equivalent in safety and effectiveness to the predicate device.

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.