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.

Device Description

The Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 are whole body CT scanners that capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, 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 document is a 510(k) summary for the Toshiba Aquilion ONE Vision CT system. While it details several modifications and general safety and testing procedures, it does not provide specific acceptance criteria or a comprehensive study report with quantitative performance metrics that would directly answer your request in the format you've outlined for acceptance criteria, sample sizes, and detailed ground truth establishment.

The document states that the submitter conducted "Risk analysis and verification/validation testing through bench testing" and "clinical evaluations" to demonstrate that the modifications meet requirements and perform as intended. However, the specific metrics, thresholds for acceptance, and detailed results are not provided in this summary.

Here's a breakdown of what can be inferred or is explicitly stated, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document mentions "image quality metric of AIDR 3D Enhanced versus current AIDR 3D is substantially equivalent to or better than the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and standard deviation of noise." It also states that SurekV selects appropriate kV and SEMAR functions similarly. However, no specific numerical acceptance criteria (e.g., "spatial resolution must be > X lp/cm") or reported performance values are given.

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

Test Set Sample Size: Not explicitly stated. The document mentions evaluation "utilizing phantoms" for image quality metrics and "clinical evaluations" for new applications. However, the number of phantoms or clinical cases is not specified.
Data Provenance (country of origin, retrospective/prospective): Not explicitly stated. Given the nature of a 510(k) submission and the description of "clinical evaluations," it's likely conducted with clinical data, but whether it's retrospective or prospective, or the origin, is not mentioned.

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

Not explicitly stated. For the "clinical evaluations" of the new applications (4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis), the document states that results "were comparable to manual measurements and/or segmentations." This implies expert involvement for these manual processes, but the number and qualifications of these experts are not detailed.

4. Adjudication Method for the Test Set:

Not explicitly stated. Since the number of experts and how "ground truth" was established for clinical evaluations is vague, the adjudication method is also not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers with vs. without AI assistance:

No, an MRMC comparative effectiveness study is not mentioned. The document describes a comparison of the modified device's performance against the predicate device and against "manual measurements and/or segmentations" for clinical applications. There's no indication of a study involving human readers' performance with and without AI assistance (as this is a CT scanner, not a diagnostic AI software).

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Yes, a form of standalone performance evaluation was done. The testing for image quality metrics (spatial resolution, CT number, CNR, noise) using phantoms, and the confirmation that SurekV selects appropriate kV and SEMAR functions similarly, are examples of standalone algorithm/system performance evaluation.

7. The Type of Ground Truth Used:

For image quality metrics (spatial resolution, CT number, CNR, noise): Phantom-based measurements. Phantoms represent a known, objective standard.
For clinical evaluations of new applications (4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis): Comparison to "manual measurements and/or segmentations." This suggests expert-derived ground truth, though the specifics are lacking.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This document is for a CT scanner, which is hardware, with software modifications including image reconstruction (AIDR 3D Enhanced) and new clinical applications. While these might have internal "training" or calibration components, the concept of a "training set" in the context of a learning algorithm for diagnostic decision support is not highlighted or described. The focus is on verifying the performance of the modified system.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not provided. (See point 8).

In summary, the provided 510(k) document is a regulatory summary focusing on demonstrating substantial equivalence to predicate devices and adherence to safety standards. It does not contain the detailed study protocols, acceptance criteria, and quantitative performance results typically found in full clinical or technical study reports.

Summary

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

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

March 10, 2015

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

Re: K142465

Trade/Device Name: Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 9, 2015 Received: February 11, 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 A Ochs

Robert Ochs. Ph.D. Acting 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) K142465

Device Name

Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ 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

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:
  February 9, 2015
1. TRADE NAME(S): Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0

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 DEVICES:

Product	Marketed by	510(k) Number	Clearance Date
Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00	Toshiba America Medical Systems	K132222	November 7, 2013
Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5,v6.00	Toshiba America Medical Systems	K133497	February 10, 2014

12. REASON FOR SUBMISSION:

Modification of a cleared device

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

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, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 is substantially equivalent to Aquilion ONE Vision, TSX-301C/1 and 301C/2, v6.00 and Aquilion ONE Vision, TSX-301C/3, 301C/4 and 301C/5, v6.00, which were cleared via Pre-Market Notification 510(k), K132222 and K133497, respectively. The Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0, incorporates modifications to the cleared device which include a new AIDR 3D selection (AIDR 3D Enhanced), the introduction of two new clinical applications, the availability of Single Energy Metal Artifact Reduction in Helical scan mode, the addition of SurekV with SURE Exposure 3D and scan protocol management. The method of operation and manufacturing process of the CT system remain unchanged from the cleared device.

Item	Aquilion ONE Vision,TSX-301C/1, /2, /3,/4, /5, /6, /7, /8, v7.0	Aquilion ONEVisionTSX-301C/1, /2v6.00	Aquilion ONE VisionTSX-301C/3, /4, /5,v6.00	Comments
510(k) Number	This submission	K132222	K133497
Noise reductionprocessing	AIDR 3DAIDR 3D Enhanced	AIDR 3D	AIDR 3D	New selectionadded (Enhanced)
Metal artifactreduction	Volume ScanHelical Scan	Volume Scan	Volume Scan	Helical scanadded

A complete comparison table is included in this submission. See below for a brief summary of changes:

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ltem	Aquilion ONE Vision,TSX-301C/1, /2, /3,/4, /5, /6, /7, /8, v7.0	Aquilion ONEVisionTSX-301C/1, /2v6.00	Aquilion ONE VisionTSX-301C/3, /4, /5,v6.00	Comments
Dose modulation	SURE Exposure 3DSure kV	SURE Exposure 3D	SURE Exposure 3D	Featureenhancement
4D OrthopedicAnalysis	Optional	N/A	N/A	New application
4D Cerebral ArteryMorphologicalAnalysis	Optional	N/A	N/A	New application
Detector	Up to 10% noisereduction *	N/A	Up to 10% noisereduction *	* Applicableconfigurations

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, IEC60601-1-9, 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, utilizing phantoms, to demonstrate that the image quality metric of AIDR 3D Enhanced versus current AIDR 3D is substantially equivalent to or better than the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio, noise properties and standard deviation of noise. Bench studies were also conducted to confirm that the SurekV feature selects the appropriate kV, to confirm that SEMAR functions similarly, with regard to image quality, when used in Volume and in Helical scan modes and that applicable configurations utilizing the "UREVision detector demonstrate improved noise reduction.

Additionally, clinical evaluations were conducted to demonstrate that the new applications 4D Orthopedic Analysis and 4D Cerebral Artery Morphological Analysis, perform as intended. The results confirmed that the applications were comparable to manual measurements and/or segmentations.

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.

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18. CONCLUSION

The modifications incorporated into the Aquilion ONE Vision, TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v7.0 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.

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.