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 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 These volume sets can be used to perform specialized studies, orqan. usinq indicated software/hardware, of the whole orqan by a trained and qualified physician.

FIRST 2.1 is an iterative reconstruction alqorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.

Device Description

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 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 2.1, intended to reduce exposure dose while maintaining and/or improving image quality.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and discussing improvements. Explicit, quantitative acceptance criteria are not clearly defined as pass/fail thresholds in the same way they might be for a novel device with a specific performance claim. Instead, the "acceptance criteria" are implied by showing the new device performs "substantially equivalent to or demonstrates an improvement" over the predicate device, particularly in terms of image quality and dose reduction.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Image Quality	Substantially equivalent to or improved over predicate device.	- CT image quality metrics (spatial resolution, CT number magnitude/uniformity, noise properties, low contrast detectability/CNR, contrast-to-noise ratio, uniformity, slice sensitivity profile, modulation transfer function, line pair gauge, standard deviation of noise, noise power spectra) were found "substantially equivalent to or demonstrates an improvement to the predicate device."- Diagnostic quality images for head, chest, abdomen/pelvis, extremity, and cardiac exams.- Superior LCD performance with FIRST.
Dose Reduction	Demonstrate dose reduction while maintaining/improving image quality.	- Dose reduction claim with a range of 59.2% to 82.4% supported.- 49.2% noise reduction demonstrated with FIRST.- Low Contrast Detectability (LCD) comparability at full dose (FBP) and reduced dose (FIRST 2.1) using a non-inferiority analysis with a model observer approach.
suRE Subtraction Angio	Improved visibility of contrast enhancement over predicate device.	- Visual assessment by doctors and clinical case examples determined "the visualization of contrast enhancement, especially blood vessels, are improved when compared to the predicate device."
suRE Subtraction Iodine Mapping	Functions as intended to assess contrast enhancement and provide additional information for abdominal organs.	- Visual assessment of clinical case examples determined "provides additional information for the assessment of abdominal organs, differential enhancement mapping images are useful visualization tools and CE Boost images provide improved CNR."

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

Test Set Sample Size:
- Image Quality Metrics (Phantoms): Not explicitly stated, as it uses phantoms for objective measurements.
- Quantitative Dose Reduction/Spatial Resolution Evaluations: Not explicitly stated, as it uses phantoms and a model observer approach to simulate human perception.
- suRE Subtraction Angio & Iodine Mapping (Clinical Evaluation): Refers to "clinical case examples" but does not specify the number of cases.
- Diagnostic Image Quality: "Representative diagnostic images" were obtained, but the number is not specified.
Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" (phantoms), "model observer studies," and "clinical evaluation/case examples," implying a mix of objective measurements and human review of images. It does not state whether the clinical evaluations were retrospective or prospective, though "clinical case examples" often implies retrospective.

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

Quantitative Dose Reduction/Spatial Resolution Evaluations (LCD): "A model observer approach which incorporates some aspects of human vision was used." This is not human expert ground truth but an algorithm mimicking human perception.
suRE Subtraction Angio & Iodine Mapping: "Visual assessment scoring method by doctors" (Angio) and "visual assessment scoring method of clinical case examples" (Iodine Mapping). The number of doctors/experts is not specified. Their qualifications are broadly stated as "doctors" for Angio and not specified beyond "visual assessment" for Iodine Mapping.
Diagnostic Image Quality: "Representative diagnostic images, reviewed by an American Board Certified Radiologist." The number of radiologists is not specified (could be one or more). The qualification is "American Board Certified Radiologist."

4. Adjudication Method for the Test Set

Not explicitly stated for the qualitative assessments. For the "visual assessment scoring method by doctors," it's not clear if there was a consensus process (e.g., 2+1, 3+1), or if individual assessments were aggregated.
For the dose reduction and image quality metrics using phantoms, adjudication is not applicable as it involves objective measurements or a model observer.

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

No, an MRMC comparative effectiveness study involving human readers comparing AI-assisted vs. non-AI-assisted performance was not explicitly described.
The document describes comparisons between images reconstructed with FIRST 2.1 (iterative reconstruction, the "AI" component) and Filtered Back Projection (FBP, the older method) in terms of objective metrics and model observer studies for dose reduction/spatial resolution.
For the suRE Subtraction features, it mentions "visual assessment scoring method by doctors" comparing the new features to the predicate device, but this is not framed as a rigorous MRMC study comparing human performance with and without the AI (FIRST 2.1) or the suRE features' assistance. It focuses on the features providing improved image visibility or additional information.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance assessment was conducted.
The "Image Quality Evaluation" and "Quantitative Dose Reduction/Spatial Resolution Evaluations" sections primarily describe the standalone performance of the FIRST 2.1 algorithm. This includes:
- CT image quality metrics (spatial resolution, noise, CNR, etc.) performed using phantoms.
- The dose reduction and noise reduction claims were established by comparing FIRST 2.1 to FBP using phantom data and a model observer approach, which is an algorithmic assessment of image quality.
- PUREViSION Optics (LCD and Noise Improvement) was evaluated via model observer studies using phantoms.

7. Type of Ground Truth Used

Phantom Data: For image quality metrics, dose reduction, and noise reduction evaluations (e.g., spatial resolution, CT number accuracy, low contrast detectability). This is an objective, physical standard.
Model Observer Approach: Used for low contrast detectability in the dose reduction studies. This is an algorithmic simulation of human perception, not human expert consensus or clinical outcomes.
Expert Visual Assessment/Clinical Case Examples: For suRE Subtraction Angio and Iodine Mapping, and for overall diagnostic image quality. This relies on medical expertise but is qualitative and subject to inter-observer variability if not rigorously adjudicated.

8. Sample Size for the Training Set

The document does not provide any information regarding the training set sample size for the FIRST 2.1 iterative reconstruction algorithm. This information is typically proprietary to the manufacturer and not usually included in 510(k) summaries unless specifically relevant to a new and unprecedented AI claim.

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

Since the training set sample size is not provided, how its ground truth was established is also not described in this document. Iterative reconstruction algorithms like FIRST 2.1 are developed by optimizing parameters based on phantom data, simulated noise models, and sometimes a large dataset of patient images with associated image quality metrics, but the specifics are not detailed here.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 30, 2017

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

Re: K170177

Trade/Device Name: Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 26, 2017 Received: May 30, 2017

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

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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.

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/ResourcesforYou/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,

Michael D.'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)

K170177

Device Name

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

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

SUBMITTER'S NAME: Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT: Akinori Hatanaka 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

1. Date Prepared:
  January 17, 2017

6. TRADE NAME(S):

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

COMMON NAME: 7.

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

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10. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

Product	Marketed	Regulation	Regulation	Product Code	510(k)	Clearance
	by	Number	Name		Number	Date
AquilionONE Visionwith FIRST2.0 (CCRS-001B) V7.4	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K161009	07/22/2016
AquilionONE (TSX-305A/3)V7.3	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K160587	06/09/2016

11. PREDICATE DEVICE:

12. REASON FOR SUBMISSION:

Modification to a previously cleared 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 2.1 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.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1, is substantially equivalent to the Aquilion ONE (TSX-305A/3) V7.3, which received premarket clearance under K160587, marketed by Toshiba America Medical Systems. The changes made to the subject device include the addition

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of FIRST 2.1, 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.

ltem	Aquilion ONE(TSX-305A/3) V8.3with FIRST 2.1	Aquilion ONE(TSX-305A/3)V7.3	Aquilion ONE Visionwith FIRST 2.0(CCRS-001B) V7.4
510(k) Number	This submission	K160587	K161009
Exposure Dose Reduction(Anatomical Region)	AIDR 3D (WholeBody)FIRST 2.1(Abdomen, pelvis,chest, cardiac,extremities andhead)	AIDR 3D (WholeBody)	AIDR 3D (WholeBody)FIRST 2.0(Abdomen, pelvis,chest, cardiac, andextremities)
Quantitative DoseReduction Claim	Yes	None	Yes
Image Quality Claim	Improved SpatialResolution overFiltered BackProjection	No Change	Improved SpatialResolution overFiltered BackProjection
sure Subtraction Angio	Available	Not Available	New Feature
suRE Subtraction lodine Mapping	Available	Not Available	New Feature

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, IEC60601-1-2, 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 demonstrate that the established specifications for the device have been met. CT image quality metrics were performed, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number magnitude/uniformity, noise properties and low contrast detectability/CNR performance.

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

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device with regard to contrast-to noise ratio, CT number accuracy, uniformity, slice sensitivity profile, modulation transfer function, low contrast detectability, line pair gauge, standard deviation of noise and noise power spectra.

Quantitative Dose Reduction/Spatial Resolution Evaluations

A dose reduction study was conducted and based on the results, a dose reduction claim with the range 59.2 to 82.4% is supported, as well as a claim of dose reduction that demonstrated a 49.2% noise reduction with FIRST on the Aquilion ONE Genesis Edition. In addition, the testing demonstrates superior LCD performance with FIRST.

These claims were evaluated by comparing Toshiba's iterative reconstruction algorithm, FIRST version 2.1, to filtered backprojection on the Aquilion ONE Genesis Edition system. The dose reduction value was established by demonstrating comparability of low contrast detectability at full dose reconstructed with filtered backprojection (FBP), and at reduced dose reconstructed with FIRST 2.1 (IR). A model observer approach which incorporates some aspects of human vision was used for investigation and a non-inferiority analysis conducted. The noise reduction value was established by comparing the standard deviation of noise magnitude at full dose with FBP with the standard deviation of noise magnitude at variety of dose reduction levels using IR. The study was designed to use clinically realistic dose levels (i.e. acquisition techniques).

PUREViSION Optics Quantitative LCD and Noise Improvement

The subject device demonstrated improvements in low contrast detectability and noise reduction at the same dose as evaluated via model observer studies (MITA-FDA LCD Head and MITA-FDA LCD Body phantoms).

suRE Subtraction Angio Evaluation

A clinical evaluation was conducted to assess whether or not the visibility of contrast enhancement was improved using 80855ubtraction Angio over the predicate device. Utilizing a visual assessment scoring method by doctors and clinical case examples it was determined that the visualization of contrast enhancement, especially blood vessels, are improved when compared to the predicate device.

suRE Subtraction Iodine Mapping Evaluation

In order to determine if Subtraction lodine Mapping functions as intended as an adjunct visualization tool to assess the enhancement of the visibility of contrast agents and the ability to provide additional information of abdominal organs, a clinical evaluation was conducted. Utilizing a visual assessment scoring method of clinical case examples it was determined that បឋម Subtraction lodine Mapping provides additional information for the assessment of abdominal organs, differential enhancement mapping images are useful visualization tools and CE Boost images provide improved CNR.

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.

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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 (TSX-305A/3) V8.3 with FIRST 2.1 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.