The Aquilion 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 LB Triton, TSX-201A/2, v4.91 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Toshiba Aquilion LB Triton (K123500) and its acceptance criteria and supporting studies:

This submission is for a modification to a cleared CT scanner, the Aquilion LB CT Scanner TSX-201A. The changes involve increased image reconstruction speed, increased high voltage generator, noise reduction processing software (AIDR 3D) as a standard feature, and an upgraded computer console. The core imaging chain (gantry, detector/DAS, tube, beam limiting device) remains unchanged.

The study presented focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against novel acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a modification of an existing device and the primary goal is to demonstrate "substantial equivalence," the "acceptance criteria" are essentially that the modified device performs comparably to the predicate device in terms of image quality metrics and diagnostic quality, without introducing new safety or effectiveness concerns.

Acceptance Criteria (Demonstrated Substantial Equivalence)	Reported Device Performance and How It Meets Criteria
Image Quality Metrics: Substantial equivalence to predicate device (Aquilion LB CT Scanner TSX-201A) regarding spatial resolution, CT number, contrast-to-noise ratio, uniformity, noise properties, and low contrast resolution.	"An image quality metrics study utilizing phantoms validated that the subject device is substantially equivalent to the predicate device (Aquilion LB CT Scanner TSX-201A) with regard to spatial resolution, CT number and contrast-to-noise ratio, uniformity, noise properties and low contrast resolution."
Diagnostic Image Quality: Produces images of diagnostic quality for representative anatomical regions.	"Additionally, representative diagnostic images 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."
Image Appearance/Representative Structures: Produces substantially equivalent images of representative structures compared to the predicate device.	"Image comparison data using brain, chest, abdomen and pelvis anthropomorphic phantoms, utilizing clinical scan conditions and reconstruction parameters, demonstrated that the subject device produces substantially equivalent images of representative structures as compared to the predicate device, Aquilion LB CT Scanner TSX-201A."
Safety and Effectiveness: Maintains safety and effectiveness consistent with predicate devices, with no change to indications for use.	"The modifications incorporated into the Aquilion LB Triton... do not change the indications for use or the intended use of the device. Based upon this information, conformance to standards, application of design controls and the performance data presented in this submission, Toshiba America Medical Systems, believes that the Aquilion LB Triton... is substantially equivalent in safety and effectiveness to the predicate devices."

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

Sample Size for Test Set:
- Phantoms: The document mentions "brain, chest, abdomen and pelvis anthropomorphic phantoms" for image comparison data and "phantoms" for image quality metrics. The exact number of phantoms or scans performed on them is not specified.
- Clinical Studies (Diagnostic Images): The document states "representative diagnostic images including brain, chest, abdomen and peripheral exams were obtained using the subject device." The exact number of patients/exams for these diagnostic images is not specified.
Data Provenance: The document does not explicitly state the country of origin. Given the submitter is "Toshiba America Medical Systems, Inc." located in Tustin, CA, it is plausible the testing was conducted in the US or involved data from US-based sites, but this is an inference. The study appears to be prospective for the purpose of this submission, as the data collection was specifically to demonstrate substantial equivalence of the modified device.

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

Number of Experts: The document does not specify the number of experts used for any evaluation, nor does it explicitly state the process for "ground truth" establishment by experts.
Qualifications of Experts: The document does not provide qualifications for any potential experts involved.

It's important to note that the study relied heavily on phantom data for quantitative image quality metrics and demonstration of diagnostic quality using representative images, rather than a formal reader study with expert-established ground truth on patient cases.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1). The nature of the study, which relies on phantom-based image metric comparisons and qualitative assessment of diagnostic images, typically does not involve adjudication as seen in clinical trials with expert readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through technical performance metrics and qualitative diagnostic image assessment, not on measuring human reader performance improvement with or without AI assistance.

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

Yes, in essence, the image quality metrics study using phantoms and the image comparison data using anthropomorphic phantoms can be considered a form of standalone performance evaluation. The device (algorithm and hardware) produced images, and those images were then analyzed for various technical attributes (spatial resolution, CT number, CNR, uniformity, noise properties, low contrast resolution) directly, without a human interpretation step as the primary outcome. The "diagnostic quality" assessment also refers to the images themselves.

7. The Type of Ground Truth Used

Phantom Gold Standard: For the image quality metrics (spatial resolution, CT number, CNR, uniformity, noise properties, low contrast resolution), the "ground truth" is established by the physical properties of the phantoms themselves and quantitative measurements derived from them, compared to the expected performance from the predicate device.
Implicit Diagnostic Quality: For the "representative diagnostic images," the "ground truth" is implied to be the acceptable diagnostic quality as determined by experienced clinical practitioners (though the document doesn't detail the assessment method or who performed it). There's no mention of pathology, clinical outcomes, or expert consensus on a specific finding for these images.

8. The Sample Size for the Training Set

The document does not provide any information about a training set. This submission is for a CT scanner's hardware and software modification, not a machine learning or AI algorithm that typically requires a specific training set of medical images. While the AIDR 3D noise reduction software is mentioned, the details of its development (including training data) would likely have been part of its original 510(k) clearance (K113466) and are not elaborated upon here.

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

Since no information regarding a training set is provided, the method for establishing its ground truth is also not described.

Summary

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K123500
Page 1 of 3

SYSTEMS, INC. TOSHIBA AMERICA MEDICA 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

4. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000

1. Date Prepared: November 8, 2012 (Updated: March 22, 2013)

6. TRADE NAME(S): Aquilion LB Triton, TSX-201A/2, v4.91

1. COMMON NAME: . System, X-ray, Computed Tomography
1. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
1. 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 LB CT Scanner TSX-201A	Toshiba AmericaMedical Systems	K050458	March 10, 2005
Aquilion ONE TSX-301A/2, w/4.74ER(Dose Reduction Technology)	Toshiba AmericaMedical Systems	K113466	April 10, 2012

2 2013 MAY

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K123500
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12. REASON FOR SUBMISSION:

Modification of a cleared device

13. DEVICE DESCRIPTION:

14. SUMMARY OF INTENDED USES:

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

The Aquilion 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.

15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aquilion LB CT Scanner, TSX-201A, K050458, marketed by Toshiba America Medical Systems. The Aquillion LB Triton, TSX-201A/2, v4.91, includes modifications to the cleared device which improves image reconstruction speed and includes the addition of optional software features. There is no change to the imaging chain in the gantry. The method of operation, base software and manufacturing process remain unchanged from the cleared device.

Additionally, this device is substantially equivalent to the Aquilion ONE TSX-301A/2, w/4.74ER, K113466, in that it includes the previously cleared dose reduction technology, AIDR 3D.

Item	Aquilion LB TritonTSX-201A/2, v4.91	Aquilion LB CTScanner TSX-201A(K050458)	Aquilion ONE TSX-301A/2, w/4.74ER(K113466)
Image reconstruction(maximum speed)	22 images per second	12 images per second	30 images per second
X-ray GeneratorOutput Power	72kW Maximum	60kW Maximum	70kW Maximum
Dose Reduction	SureExposure 3D	Real EC	SureExposure 3D
Noise ReductionProcessing	QDSAIDR 3D	N/A	QDSAIDR 3D
Console	• 2.53 GHz CPU ClockFrequency• 12 GB or more CPUMemory• DVD Drive	• 2 GHz CPU ClockFrequency• 2 GB or more CPUMemory• CD Drive	• 3.0 GHz CPU ClockFrequency• 8 GB or more CPUMemory• DVD Drive

Summary of Changes:

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K123500
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1. Increased image reconstruction speed
1. High voltage generator is increased
ని. Noise reduction processing software is now a standard feature
1. The computer console has been upgraded, which includes a faster CPU, additional CPU memory, a DVD Drive.
ട. An optional Display Console Kit is now available.
1. Previously cleared software options are being added

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, IEC60601-1-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-4, IEC60601-1-6, IEC60601-1-8, IEC60601-1-9, IEC60601-2-28. IEC60601-2-32. IEC60601-2-44. IEC60825-1. IEC62304. IEC62366. NEMA PS 3.1-3.18 and NEMA XR-25.

Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

17. TESTING

There is no change to the imaging chain in the gantry (i.e. geometry, detector/DAS, tube, beam limiting device). Image comparison data using brain, chest, abdomen and pelvis anthropomorphic phantoms, utilizing clinical scan conditions and reconstruction parameters, demonstrated that the subject device produces substantially equivalent images of representative structures as compared to the predicate device, Aquilion LB CT Scanner TSX-201A.

An image quality metrics study utilizing phantoms validated that the subject device is substantially equivalent to the predicate device (Aquilion LB CT Scanner TSX-201A) with regard to spatial resolution, CT number and contrast-to-noise ratio, uniformity, noise properties and low contrast resolution.

Additionally, representative diagnostic images 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.

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 with satisfactory results.

18. CONCLUSION

The modifications incorporated into the Aquilion LB Triton, TSX-201A/2, v4.91 do not change the indications for use or the intended use of the device. Based upon this information, conformance to standards, application of design controls and the performance data presented in this submission, Toshiba America Medical Systems, believes that the Aquilion LB Triton, TSX-201A/2, v4.91, is substantially equivalent in safety and effectiveness to the predicate devices.

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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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing protection and care.

Public Health Service

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

May 2. 2013

TOSHIBA AMERICA MEDICAL SYSTEMS, INC. % Mr. Paul Biggins Director, Regulatory Affairs 2441 Michelle Drive TUSTIN CA 92780

Re: K123500

Trade/Device Name: Aquilion LB Triton, TSX-201A/2, v4.91 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 22, 2013 Received: March 28, 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) (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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Page 2 - Mr. Biggins

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" (21CFR 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,

Sm-7)

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): K123500

Device Name: Aquilion LB Triton, TSX-201A/2, v4.91

Indications for Use:

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

The Aquilion 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.

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

Over-The-Counter Use (21 CFR 801 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)

Sm. 7)

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

K123500 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.