The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

Device Description

The Aquilion Lightning, TSX-035A/4 and /5, v7.0 is a 16-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. This system is based upon the technology and materials of previously marketed Toshiba CT systems.

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification for a Computed Tomography (CT) X-ray system (Aquilion Lightning, TSX-035A/4 and /5, V7.0). This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market.

This specific document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., using metrics like sensitivity, specificity, or performance against a ground truth dataset).

The document primarily focuses on:

Indications for Use: What the device is intended for.
Technological Characteristics Comparison: How the new device differentiates from its predicate (e.g., gantry rotation speed, X-ray rated output, patient couch specifications).
Safety and Performance Standards Conformance: Listing of relevant IEC standards and CFR parts that the device adheres to.
Testing: Mentions "summary tables detailing the risk analysis and verification/validation testing conducted through bench testing" and "successful completion of software validation." It does not provide details of such studies or specific performance metrics that would be considered acceptance criteria for AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because these are not present in the provided text. This document is for a general CT system, not an AI-powered diagnostic algorithm with performance metrics relative to a ground truth dataset.

Summary

{0}------------------------------------------------

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 design 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

April 1, 2016

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

Re: K153263

Trade/Device Name: Aquilion Lightning, TSX-035A/4 and /5, V7.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 2, 2016 Received: March 3, 2016

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.

{1}------------------------------------------------

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.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K153263

Device Name

Aquilion Lightning, TSX-035A/4 and /5, V7.0

Indications for Use (Describe)

This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

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

ال 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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:

March 2, 2016

6. TRADE NAME(S): Aquilion Lightning, TSX-035A/4 and /5, V7.0

1. COMMON NAME: 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

10. PERFORMANCE STANDARD:

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

{4}------------------------------------------------

11. PREDICATE DEVICE:

Product	Marketed	Regulation	Regulation	Product Code	510(k)	Clearance
	by	Number	Name		Number	Date
AquilionLightning,TSX-035A/2	ToshibaAmericaMedicalSystems	21 CFR892.1750	ComputedTomographyX-ray System	JAK:System, X-ray,Tomography,Computed	K151833	October 9,2015

12. REASON FOR SUBMISSION:

Modification to 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.

The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software, by a trained and qualified physician.

15. SUBSTANTIAL EQUIVALENCE:

The Aquilion Lightning, TSX-035A/4 and /5, v7.0, is substantially equivalent to the Aquilion Lightning, TSX-035A/2, that received premarket clearance under K151833 and is marketed by Toshiba America Medical Systems. The Indications for Use for the subject device are identical to those of the predicate device. See below for a brief comparison of the technological characteristics between the subject and the predicate devices:

Item	Aquilion Lightning, TSX-035A/4 and /5	Aquilion Lightning, TSX-035A/2
510(k) Number	This submission	K151833
Gantry RotationSpeed	0.75 sec/rotationOptions:• 0.6 sec (Available when 0.6s Fast Scan Kit,CGS-61A, is installed)• 0.5 sec (Available when 0.5s Fast Scan Kit,CGS-67A, is installed)	0.75 sec/rotationOption:• 0.6 sec (Available when 0.6sFast Scan Kit, CGS-61A, isinstalled)
Detector	800 channels × 16 rows	800 channels × 16 rows
FOV (field of view)	180/240/320/390/500 mm	180/240/320/390/500 mm

{5}------------------------------------------------

X-ray rated output	Max. 36 kWOption:• Max. 50.4kW when X-ray Power-Up Kit,CSGS-016A is installed				Max. 36 kW
X-ray tube voltageX-ray tube current	80/100/120/135 kV10-300 mAOption:• 10-420 mA when X-ray Power-Up Kit,CSGS-016A is installed				80/100/120/135 kV10-300 mA
X-ray fan angle	43.9°				43.9°
Patient Couch	Long Type	Long Type	Short Type	Short Type	Long Type	Short Type
• Couch-top stroke	2190mm	2390mm	1890mm	1890mm	2190mm	1890mm
• Scan permissible range(Conventional)	1830mm	2030mm	1530mm	1530mm	1830mm	1530mm
• Scan permissible range (Helical)	1780mm	1980mm	1480mm	1480mm	1780mm	1480mm
• Max. guaranteed weight	205kg	300 kg	205kg	300 kg	205kg	205kg
Noise reduction processing	QDS, AIDR 3D , AIDR3D Enhanced				QDS, AIDR 3D , AIDR3D Enhanced
Metal Artifact Reduction	SEMAR (Helical Scan)				SEMAR (Helical Scan)
Gantry opening size (diameter)	780 mm				780 mm
Tilt angle	±30°				±30°
Installation area(Short patient couch)	Minimum 17.2m²(14.4 m² )				Minimum 17.1m²(14.3 m² )

{6}------------------------------------------------

CT Cardiac Function Analysis Software	Previously cleared under K023760
Sure Plaque	Previously cleared under K043111
ECG-Gating Reconstruction System	Previously cleared under K991766
Scan Protocol Management	Previously cleared under K142465
4D Airways Analysis	Previously cleared under K143294

Previously cleared software options being implemented to the modified device:

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, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, 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 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. Evaluation of the modified device included, but was not limited to, confirmation that the associated performance specifications related to the increased X-ray generator output, increase of the rotation speed, implementation of a new patient couch and application software previously cleared on other Toshiba CT systems, were 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 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 Lightning, TSX-035A/4 and /5, v7.0, performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon bench testing, successful completion of software validation and application of risk management and design controls, 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.