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

Device Description

The Aquilion LB, TSX-201A/3, v6.0 is a 40-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

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Study Details for Aquilion LB, TSX-201A/3, V6.0

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary for the Toshiba Aquilion LB, TSX-201A/3, V6.0, primarily focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel performance claims against specific, quantitative acceptance criteria. Therefore, the "acceptance criteria" here are implicitly tied to maintaining or improving upon the performance of the predicate device and meeting general safety and image quality standards for CT systems.

Acceptance Criteria Category	Reported Device Performance
Detector Performance	- Detector sensitivity and noise properties (including standard deviation of noise) demonstrated improvement compared to the previous detector.
Image Quality Metrics (Phantom)	- Subject device demonstrated substantial equivalence to the predicate device with regard to: - Spatial resolution - CT number - Contrast-to-noise ratio - Uniformity performance
Diagnostic Image Quality (Clinical)	- Representative diagnostic images (brain, chest, abdomen, peripheral exams) obtained using the subject device and reviewed by an American Board Certified Radiologist demonstrated that the device produces images of diagnostic quality and performs as intended.
Lung Volume Analysis Software Functionality	- Integration testing was conducted to verify that this application functions as intended on the Aquilion LB system. (Note: The algorithm itself was previously cleared and demonstrated accurate volume calculations using an electronic phantom, LungMan Phantom, and chest image datasets).
Safety and Regulatory Compliance	- Device designed and manufactured under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards. - Conforms to applicable parts of various IEC standards (e.g., IEC60601-1, IEC60601-2-44, etc.), NEMA standards (PS 3.1-3.18, XR-25, XR-26). - Complies with all applicable requirements of radiation safety performance standards (21 CFR §1010 and §1020). - Risk analysis and verification/validation testing conducted through bench testing demonstrates that the requirements for modifications have been met. - Software Documentation for a Moderate Level of Concern per FDA guidance. - Testing in accordance with applicable IEC standards.

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

Due to the nature of this 510(k) submission, which is for a modification of an existing CT system, the "test set" primarily refers to data used for phantom studies and representative clinical images rather than a large-scale clinical study with a specific patient sample size.

Sample Size for Test Set:
- Phantom Studies: Not explicitly quantified, but performed using "phantoms" for image quality metrics.
- Clinical Images: "Representative diagnostic images" were obtained. The exact number of patients or images is not specified.
- Lung Volume Analysis: Previously demonstrated using an "electronic phantom, LungMan Phantom and image data sets of the chest." The number of image datasets is not specified for this prior clearance.
Data Provenance: Not explicitly stated (e.g., country of origin). The document describes typical verification and validation activities for a medical device manufacturer. Given Toshiba Medical Systems Corporation is based in Japan and Toshiba America Medical Systems, Inc. is in the US, the testing could have occurred in either or both regions. The studies appear to be retrospective in the sense that they are conducted for verification and validation purposes after device modification, not as a prospective clinical trial.

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

Clinical Image Review: "Representative diagnostic images, reviewed by an American Board Certified Radiologist."
- Number of Experts: One ("an American Board Certified Radiologist").
- Qualifications: American Board Certified Radiologist. No specific years of experience are mentioned.
Phantom Studies and Detector Performance: Ground truth for these technical assessments is typically established by physical measurements and engineering specifications, not human experts.
Lung Volume Analysis: The ground truth for the software's accuracy was previously established, at the time of K133715 clearance, using physical (LungMan Phantom) and electronic phantoms, for which the true volumes are known, and image datasets of the chest. The role of experts in establishing ground truth for these past tests isn't detailed in this document, but typically involves engineers/physicists for phantom assessments.

4. Adjudication Method for the Test Set

Clinical Image Review: For the "representative diagnostic images," only one radiologist is mentioned as reviewing them. Therefore, an explicit adjudication method (like 2+1 or 3+1) involving multiple experts is not described for this specific part of the submission. The review likely served as a qualitative confirmation of diagnostic quality.
Other Testing: Adjudication methods are not applicable to phantom studies or technical performance measurements.

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

No, an MRMC comparative effectiveness study was not done according to this document. The submission focuses on demonstrating substantial equivalence of a modified device and its inherent performance, not on comparing human reader performance with and without AI assistance. The Lung Volume Analysis software is described as a post-processing application, but its impact on human reader effectiveness is not quantified in this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Yes, for certain aspects.
- Detector Performance and Image Quality Metrics (Phantoms): These are inherently standalone, algorithm-only, or device-only performance assessments. The device (Aquilion LB) is characterized directly.
- Lung Volume Analysis: For the algorithm itself, its accuracy in volume calculations (part of its previous clearance, K133715) was demonstrated using an "electronic phantom, LungMan Phantom and image data sets of the chest," implying a standalone assessment of the algorithm's output against known values or established methods. The current submission only verified its integration and proper functioning on the Aquilion LB system.

7. The Type of Ground Truth Used

Technical Specifications/Physical Measurements: For detector performance, spatial resolution, CT number, contrast-to-noise ratio, and uniformity. This ground truth is based on known physical properties of phantoms and calibrated measurement systems.
Expert Consensus/Opinion (for Clinical Images): For the "representative diagnostic images," the "American Board Certified Radiologist" provided the ground truth (or confirmation) of diagnostic quality. This is an expert opinion-based assessment.
Known Values (for Lung Volume Analysis): For the Lung Volume Analysis software, the ground truth was derived from known volumes in electronic and physical phantoms ("LungMan Phantom"). For "image data sets of the chest," the ground truth for actual volumes would likely have been established through a highly reliable method, possibly manual expert tracing on high-resolution images or comparison with other gold-standard volumetric methods (though not explicitly stated in this document).

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is expected as the submission is for a modification to a cleared CT system, not for a de novo AI algorithm that requires extensive training data. The improvements and validations described pertain to hardware changes (new detector) and software integration, not to the development or retraining of a machine learning model.

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

As no training set is mentioned or implied, this question is not applicable based on the provided document.

Summary

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

March 19, 2015

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

Re: K150003

Trade/Device Name: Aquilion LB, TSX-201A/3, V6.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 30, 2014 Received: January 2, 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)

K150003

Device Name

Aquilion LB, TSX-201A/3, V6.0

Indications for Use (Describe)

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, usinq indicated software/hardware, by a trained and qualified physician.

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)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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

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:

December 30, 2014 (Updated March 18, 2015)

6. TRADE NAME(S):

Aquilion LB, TSX-201A/3, V6.0

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

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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 Triton,TSX-201A/2, v4.91	Toshiba AmericaMedical Systems	K123500	May 2, 2013

12. REASON FOR SUBMISSION:

Modification of a cleared 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 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:

The subject device is substantially equivalent to the Aquilion LB Triton, TSX-201A/2, v4.91, K123500, marketed by Toshiba America Medical Systems. The Aquilion LB, TSX-201A/3, v6.0, incorporates modifications to the cleared device which include implementation of a new detector that meets the specifications of the current detector and addition of a previously cleared optional software feature. The method of operation and manufacturing process for the Aquilion LB remain unchanged from the cleared device.

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A complete comparison table is included in this submission. See below for a brief summary of changes from Aquilion LB Triton, TSX-201A/2, v4.91:

ltem	Aquilion LB	Aquilion LB Triton
	TSX-201A/3, v6.0	TSX-201A/2, v4.91
510(k) Number	This submission	K123500
Detector	994 channels x 40 rows	994 channels x 40 rows
Number of detector elements	16 x 0.5 mm rows	16 x 0.5 mm rows
Console Operating System	Microsoft Windows 7	Microsoft Windows XP

Previously cleared software options being implemented to the modified device:

Lung Volume Analysis	Previously cleared per K113715
----------------------	--------------------------------

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, IEC60601-2-28, 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 and noise properties (including standard deviation of noise) which demonstrated improvement in both studies.

Additional image quality metrics, utilizing phantoms, were conducted to validate that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number and contrast-to-noise ratio and uniformity performance.

The algorithm for Lung Volume Analysis, a system independent post processing software application that uses standard non-contrast enhanced chest volume (helical) acquisitions, has not been changed since clearance under K133715. As previously demonstrated through the use of an electronic phantom, LungMan Phantom and image data sets of the chest, this software accurately displays volume calculations. Integration testing was conducted to verify that this application functions as intended on the Aquilion LB system.

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Representative diagnostic images, reviewed by an American Board Certified Radiologist, including brain, chest, abdomen and peripheral exams were also 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 LB, TSX-201A/3, v6.0 do not change the indications for use or the intended use of the device. Based upon bench testing, representative clinical images, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use.

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.