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 Aquillion ONE Vision TSX-301C/1 and TSX-301C/Z, v6.00 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

AI/ML Overview

The provided text describes a 510(k) summary for the Aquilion ONE Vision CT scanner (K132222) and its modifications. However, it does not contain information about specific acceptance criteria or a study proving the device meets them with performance metrics related to diagnostic accuracy, sensitivity, or specificity.

The document states that the submission includes "summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met." It also mentions "successful completion of software validation" and compliance with various IEC, NEMA, and CFR standards.

This kind of 510(k) submission, particularly a "Special 510(k)" for modifications to a cleared device, often focuses on demonstrating that the changes do not adversely affect safety and effectiveness, and that the device still meets the performance specifications of the predicate device. It typically doesn't involve new clinical performance studies to establish acceptance criteria for diagnostic accuracy metrics in the same way a de novo device or a device with new clinical claims might.

Therefore, many of the requested categories related to clinical performance studies (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) cannot be extracted from this document as such studies are not described.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document refers to "requirements for the modifications" and "applicable standards" but does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) or report device performance against such metrics. The changes are primarily technical (OS change, image quality improvements, dose reduction availability, addition of previously cleared software).

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

Not available in the provided text. The document mentions "bench testing" and "software validation" but does not specify a test set of patient data or its characteristics.

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

Not available in the provided text.

4. Adjudication method for the test set

Not available in the provided text.

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

Not applicable/Not mentioned. The device is a CT scanner, and the modifications are largely technical and do not appear to involve AI-assisted reading or a direct comparison of human reader performance with and without AI.

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

Not applicable/Not mentioned. The device is a CT scanner, not a standalone algorithm.

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

Not available in the provided text.

8. The sample size for the training set

Not applicable/Not mentioned. There is no mention of a training set for an algorithm in this document. The "training" for a CT scanner typically refers to system calibration and quality control, not machine learning model training.

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

Not applicable/Not mentioned.

Summary of what the document DOES state regarding testing and safety:

The device is designed and manufactured under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards.
It conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020].
It complies with various IEC and NEMA standards (IEC60601-1 series, IEC60601-2-x series, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26).
A "Special 510(k) submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met."
"Software Documentation for a Moderate Level of Concern" was included.
"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."
Conclusion: "Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."

In essence, the document confirms that the modified CT scanner underwent rigorous engineering and software validation according to established industry standards and regulatory requirements, demonstrating that the modifications did not compromise the device's safety or effectiveness compared to the predicate device. However, it does not provide specific clinical performance metrics or studies as might be expected for an AI-powered diagnostic device.

Summary

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K1322222
Page 1 of 3

TOSHIBA AMERICA MEDICAL BYBTEMS, 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

NOV 07 2013

4. CONTACT PERSON: Paul Biggins

Director, Regulatory Affairs (714) 730-5000

1. Date Prepared: July 16, 2013
1. TRADE NAME(S): Aquilion ONE Vision, TSX-301C/1 and 301C/2, 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, v4:90	Toshiba AmericaMedical Systems	K122109	September 21, 2012

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12. REASON FOR SUBMISSION:

Modification of a cleared device

13. DEVICE DESCRIPTION:

14. SUMMARY OF INTENDED USES:

15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aquilion ONE Vision, TSX-301C/1, v4.90, K122109, marketed by Toshiba America Medical Systems. The Aquilion ONE Vision TSX-301C/1 and TSX-301C/2, v6.00, incorporates modifications to the cleared device which include an operating system change, image quality improvements, dose reduction availability in real time scanning and addition of previously 510(k) cleared post processing software. The indications for use, method of operation including the imaging chain, base software and manufacturing process 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, v4.90:

Item	Aquilion ONE VisionTSX-301C/1 and TSX-301C/2, v6.00	Aquilion ONE VisionTSX-301C/1, v4.90
Operating System	Windows 7	Windows XP
Subtraction Protocol	Optional	N/A
Image Quality	Metal Artifact Reduction	Beam Hardening Correction
	Improved Cone Beam Artifact Reduction	Cone Beam Artifact Reduction
	Improved MIP Image	MIP Image
Dose Reduction	AIDR available during CT Fluoroscopy	N/A
Lung Volume Analysis	Optional(Previously cleared under K113715)	N/A

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K132222
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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 IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-1-8, 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

This Special 510(k) submission includes summary tables detailing the risk analysis and verification/validation testing conducted through bench testing which demonstrates that the requirements for the modifications made to the system have been met.

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/1 and TSX-301C/2, v6.00 do not change the indications for use or the intended use of the device. Based upon bench testing, successful completion of software validation, application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and two wavy lines.

Public Health Service

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

November 7, 2013

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

Re: K132222

Trade/Device Name: Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 30, 2013 Received: October 31, 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 10 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 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/Industrv/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,

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

510(k) Number (if known):

K132222

Device Name:

Aquilion ONE Vision, TSX-301C/1 and 301C/2, 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 CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh.7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K132222 510(k)_

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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.