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.

Device Description

The Aquilion ONE Vision, TSX-301C/3 and 301C/4, v6.00 are 320-row CT Systems and the TSX-301C/5, v6.00 is a 160-row CT system consisting of the same gantry, couch and console used for data processing and display. These devices capture cross sectional volume data sets used to perform specialized studies, using indicated software, by a trained and qualified physician. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

AI/ML Overview

The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified CT system (Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00) to its predicate device. This submission is for a hardware and associated software modification to an existing CT scanner, not a new AI/CADe device. Therefore, many of the typical acceptance criteria and study elements pertinent to AI systems that you requested are not directly applicable or explicitly detailed in this document.

However, I can extract the information that is present and explain why some of your requested details might not be found in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device modification, the "acceptance criteria" are generally related to demonstrating that the modified device performs at least as well as the predicate device in terms of image quality and safety, and continues to meet relevant standards. The performance is assessed through various tests, primarily utilizing phantoms and review by an expert.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Detector Sensitivity	Improvement compared to predicate device.	Demonstrated an improvement.
Spatial Resolution	Substantially equivalent to predicate device (via phantom testing).	Validated that the subject device is substantially equivalent to the predicate device.
CT Number	Substantially equivalent to predicate device (via phantom testing).	Validated that the subject device is substantially equivalent to the predicate device.
Contrast-to-Noise Ratio (CNR)	Substantially equivalent to predicate device (via phantom testing).	Validated that the subject device is substantially equivalent to the predicate device.
Noise Properties	Substantially equivalent to predicate device (via phantom testing).	Validated that the subject device is substantially equivalent to the predicate device.
Uniformity Performance	Substantially equivalent to predicate device (via phantom testing).	Validated that the subject device is substantially equivalent to the predicate device.
Diagnostic Image Quality	Produce images of diagnostic quality.	Representative diagnostic images, including brain, chest, abdomen, and peripheral exams, were obtained using the subject device and reviewed by an American Board Certified Radiologist, demonstrating that the device produces images of diagnostic quality and performs as intended.
Compliance with Standards	Conformance to applicable regulatory and performance standards.	Conforms to Quality System Regulations (21 CFR § 820, ISO 13485), applicable IEC standards (IEC60601 series, IEC62304, IEC62366), NEMA standards (PS 3.1-3.18, XR-25, XR-26), and radiation safety standards (21 CFR §1010 and §1020).
Software Validation	Successful completion per FDA guidance.	Successful completion of software validation for a Moderate Level of Concern, per FDA guidance.
Risk Management & Design Controls	Application of appropriate methodologies.	Application of risk management and design controls.

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

Sample Size for Test Set: The document mentions "representative diagnostic images" but does not specify a numerical sample size for the clinical image review. This type of submission often relies on a qualitative assessment of a small, representative set of images rather than a large statistical study.
Data Provenance: Not explicitly stated (e.g., country of origin). Since it's a Toshiba America Medical Systems submission, the testing would likely have occurred in the US or Japan. The assessment of diagnostic images by an "American Board Certified Radiologist" suggests at least some of the data review, if not acquisition, was US-based.
Retrospective or Prospective: Not specified. Given the nature of a device modification test, it could involve prospective acquisition of new images for evaluation, or retrospective review of images acquired with the modified device.

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" (singular).
Qualifications: "American Board Certified Radiologist." The duration of experience is not specified.

4. Adjudication method for the test set

Adjudication Method: Not applicable or specified. With only one radiologist reviewing, there is no inter-reader discrepancy to adjudicate.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a CT scanner itself, not an AI/CADe accessory intended to assist human readers in image interpretation. Therefore, assessing human reader improvement with/without "AI assistance" is not relevant to this submission.

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

Standalone Performance: Not applicable. This is a conventional CT imaging system, not an algorithm being evaluated for standalone performance. The "softwar" mentioned refers to control software and image processing pathways within the CT system, not an independent AI diagnostic algorithm.

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

Type of Ground Truth: For the image quality assessment, the "ground truth" was the qualitative judgment of an "American Board Certified Radiologist" that the images were of "diagnostic quality" and that the device "performs as intended." For the phantom studies, the ground truth is against known physical properties and measurements within the phantoms, assessed by quantitative metrics (spatial resolution, CT number, CNR, noise, uniformity).

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not provided. This submission is for a hardware and control software modification to a CT scanner. The concept of a "training set" in the context of machine learning (AI) does not apply here. The system's performance is based on engineered design and physical principles, not on being trained on a dataset of images with ground truth labels.

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

How Ground Truth for Training Set was Established: Not applicable, as there is no "training set" in the AI sense for this device. The system's operational parameters and calibration are established through design specifications, factory calibration, and quality control processes.

In summary: This 510(k) submission is for a modification to a general-purpose CT imaging system. The performance evaluation focuses on demonstrating that the modified hardware and software maintain or improve the fundamental imaging capabilities and safety profiles compared to the predicate device, primarily through phantom testing and qualitative clinical image review by a radiologist. It does not involve the a-typical AI/CADe specific study designs and ground truth methodologies you would expect for an AI-powered diagnostic tool.

Summary

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FEB 10 2014

ТОВНІВА АМЕРІСА MEDICAL БУБТЕМS, INC. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) SUMMARY

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.
1. ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563
1. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
1. Date Prepared: January 21, 2014
1. TRADE NAME(S): Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00
1. COMMON NAME: System, X-ray, Computed Tomography
1. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)

9. PRODUCT CODE / DESCRIPTION:

JAK - System, Computed Tomography

10. PERFORMANCE STANDARD:

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

11. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aquilion ONE Vision,TSX-301C/1 and 301C/2,v6.00	Toshiba America MedicalSystems	K132222	November 7, 2013

12. REASON FOR SUBMISSION:

Modification of a cleared device

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13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00 which was cleared via Pre-Market Notification 510(k), K132222, marketed by Toshiba America Medical Systems. The Aquilion ONE Vision, TSX-301C/4 and 301C/5, v6.00, incorporates modifications to the cleared device which include implementation of a new detector that meets the specifications of the current detector and software controls that limit the data acquisition in the TSX-301C/5 configuration. The method of operation and manufacturing process of the CT system remain unchanged from the cleared device.

A complete comparison table is included in this submission. See below for a brief summary of changes from Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00:

Item	Aquilion ONE VisionTSX-301C/3, 301C/4 and301C/5v6.00	Aquilion ONE VisionTSX-301C/1 and301C/2v6.00	Comments
510(k) Number	This submission	K132222
Number of detectorelements	320 x 0.5 mm rows	320 x 0.5 mm rows	No Change
Maximum scan slicethickness	0.5mm x 320 slices(TSX-301C/3 and TSX-301C/4)0.5mm x 160 slices(TSX-301C/5)	0.5mm x 320 slices	Softwarecontrols limitdataacquisition

The following applications have been implemented with the subject device:

Neuro Package (K072693), Vessel View (K063184), Body Perfusion (K090504), Colon View (K090220), Lung Volume Analysis (K113715), Sure Cardio Scoring (K072737), CT Cardiac Function Analysis Software (K023760), Sure Plaque (K043111)

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K133497
page 3 of 3

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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-6, IEC60601-1-9, 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 requirements for the modifications made to the system have been met. The modified system was evaluated to assess detector sensitivity, which demonstrated an improvement and image quality metrics, utilizing phantoms, which validated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and uniformity performance. Additionally, representative diagnostic images, reviewed by an American Board Certified Radiologist, including brain, chest, abdomen and peripheral exams were 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 modified system was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

18. CONCLUSION

The modifications incorporated into the Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00 do not change the indications for use or the intended use of the device. 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 devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

February 10, 2014

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780 US

Re: K133497

Trade/Device Name: Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00 Regulation Number: 21 CFR 892.1750 Regulation Name: System, Computed Tomography, X-Ray Regulatory Class: Il Product Code: JAK Dated: November 12, 2013 Received: November 14, 2013

Dear Mr. Biggins:

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) (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

for

Janine M. Morris 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):

K133497

Device Name:

Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sm.h.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 1 of _ 1

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.