This device is indicated to acquire and display cross sectional volumes of the whole 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, of the whole organ by a trained and qualified physician.

FIRST 1.0 is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for chest (excluding cardiac), abdomen and pelvis applications. This algorithm is not intended for head or extremity applications.

Device Description

Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) 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 1.0, intended to reduce exposure dose while maintaining and/or improving image quality.

AI/ML Overview

The provided text describes the Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) CT system and its iterative reconstruction algorithm, FIRST 1.0. Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal of FIRST 1.0)	Reported Device Performance (Summary)
Reduce exposure dose	Up to 82.2% dose reduction compared to FBP for equivalent low contrast detectability.
Improve high contrast spatial resolution	Improved spatial resolution over FBP.
Maintain and/or improve image quality	Equivalent low contrast detectability to FBP with dose reduction. Visual reduction of streak artifacts and improved image SD values in shoulders compared to AIDR 3D. Diagnostic quality images (visually confirmed by Radiologist).
No significant artifacts/missing anatomical structures	Visually confirmed (by Radiologist) that no significant artifacts and missing anatomical structures occur.

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

Quantitative Dose Reduction Evaluation: A simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it) was used. This indicates a phantom study, not human data.
Artifact Reduction: A body phantom was used for truncation and streak artifact assessment. This indicates a phantom study.
Image Quality Check: Existing clinical data was used. The specific sample size of clinical cases is not provided. The provenance of this clinical data (e.g., country of origin, retrospective/prospective) is not specified.

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

For the "Image Quality Check" using existing clinical data, one American Board Certified Radiologist reviewed a representative diagnostic image set for chest, abdomen, and pelvis exams. Their specific years of experience are not provided, only that they are "American Board Certified."
For the quantitative dose reduction and artifact reduction studies, phantoms were used, so expert ground truth establishment for patient images was not directly applicable.

4. Adjudication Method for the Test Set

For the image quality check, with only one American Board Certified Radiologist reviewing images, there was no adjudication method (e.g., 2+1, 3+1) described.
For the phantom studies, the assessment was based on objective measurements (e.g., model observer evaluation, image SD values) and visual comparison to AIDR 3D, and thus, an adjudication method for experts was not applicable.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly described. The document mentions a single radiologist's review of diagnostic images and phantom studies. No comparison of human reader performance with and without AI assistance is presented.

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

Yes, a standalone performance assessment was conducted for FIRST 1.0.
- Quantitative Dose Reduction Evaluation: This was performed using a "model observer evaluation" on a phantom, indicating an algorithm-only assessment of low contrast detectability.
- Image Quality Evaluation (Phantom Studies): Various CT image quality metrics (spatial resolution, CT number accuracy, contrast-to-noise ratio, noise properties, uniformity, slice sensitivity profile, low contrast detectability, standard deviation of noise) were measured using phantoms, which are objective algorithm-only assessments.
- Artifact Reduction (Phantom Studies): Objective measures like image SD values and visual comparisons (implied to be algorithm output comparison) were made.

7. The Type of Ground Truth Used

Phantom Measurements: For quantitative dose reduction, spatial resolution, CT number accuracy, CNR, noise properties, uniformity, SSP, low contrast detectability, and artifact reduction, the ground truth was derived from objective measurements on phantoms (e.g., MITA-FDA phantom, body phantoms).
Expert Visual Confirmation: For the "Image quality check" using clinical data, the ground truth for "diagnostic quality" and "no significant artifacts and missing anatomical structures" was established by visual confirmation from a single American Board Certified Radiologist.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for training the FIRST 1.0 algorithm.

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

The document does not provide any information regarding how the ground truth for the training set was established.

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

November 27, 2015

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

Re: K151673

Trade/Device Name: Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 20, 2015 Received: October 21, 2015

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,

Robert Ools

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) K151673

Device Name Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:

June 19, 2015 (Updated November 24, 2015)

6. TRADE NAME(S):

Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)

7. COMMON NAME:

System, X-ray, Computed Tomography

8. DEVICE CLASSIFICATION:

Class II (per 21 CFR 892.1750, Computed Tomography X-ray System)

9. PRODUCT CODE / DESCRIPTION:

90JAK / 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 Vision,TSX-301C/1-8, V7.0	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K142465	03/10/2015

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.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE Vision with FIRST 1.0 (CCRS-001A), is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1-8, V7.0, that received premarket clearance under K142465 and is marketed by Toshiba America Medical Systems. The changes made to the subject device include the addition of FIRST 1.0, CCRS-001A, 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 with FIRST 1.0(CCRS-001A)	Aquilion ONE (TSX-301C/1-8) V7.0
510(k) Number	This submission	K142465
Anatomical Region	Chest (excluding cardiac),abdomen and pelvis	Whole Body
Exposure Dose Reduction	AIDR 3DFIRST 1.0	AIDR 3D
Quantitative Dose ReductionClaim	Yes	None
Image Quality Claim	Improved Spatial Resolution	No change

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, IEC60601-1-1, 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 spatial resolution, CT number accuracy, contrast-to-noise ratio, noise properties, uniformity, slice sensitivity profile, low contrast detectability and standard deviation of noise. Studies were also conducted to demonstrate equivalence and/or improvements in CT number accuracy in water phantoms and artifact reduction using body phantoms.

Quantitative Dose Reduction Evaluation

The subject device demonstrated a dose reduction claim of up to 82.2% compared to filtered back projection as demonstrated by a model observer evaluation which showed that equivalent low contrast detectability to FBP (range from 0.6 - 0.686) can be achieved with 51.7% to 82.2% less dose using FIRST1.0 at Standard setting for thin (0.5 mm) reconstruction slice thickness in simulated body phantom (MITA-FDA phantom with a body ellipse surrounding it).

Artifact Reduction

For truncation artifacts, a body phantom was scanned at 25/50/150 mA and 80/160/320 rows and FIRST reconstruction was performed. It was confirmed that the image SD values in the shoulders have been improved and streak artifacts have been visually reduced, as compared with AIDR 3D. For streak artifacts, a body phantom was scanned at 25/50/150 mA and 80/160/320 rows and FIRST reconstruction was performed. It was confirmed that the image SD values in the shoulders have been improved and streak artifacts have been visually reduced, as compared with AIDR 3D. Image quality check was performed using the existing clinical data. Images obtained with FIRST were compared with those obtained with FBP and AIDR 3D. It was visually confirmed that no significant artifacts and missing anatomical structures occur in FIRST.

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Representative diagnostic images, reviewed by an American Board Certified Radiologist, including chest, abdomen and pelvis 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 1.0 (CCRS-001A), 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.