The Aquilion Prime 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 PRIME TSX-303A/A and /B, v6.00 are 80-row CT Systems and the TSX-303A/F, v6.00 is a 40-row CT system that is intended to produce axial scans of the whole body to include the head. These systems are based upon the technology and materials of previously marketed Toshiba CT systems.

AI/ML Overview

This document is a 510(k) premarket notification for a Computed Tomography (CT) system, the Aquilion PRIME, v6.00. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for a novel AI-powered diagnostic device.

Therefore, the information regarding "acceptance criteria" and the "study that proves the device meets the acceptance criteria" is framed within the context of demonstrating equivalence and safety/effectiveness for a hardware/software update to an existing CT system, rather than a standalone performance study with clinical endpoints.

Here's an attempt to extract the closest available information based on your request, acknowledging that the format and detail for a conventional "acceptance criteria" study are not fully present in this type of submission.

1. A table of acceptance criteria and the reported device performance

Based on the document, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and meeting regulatory standards for CT systems. The "reported device performance" is described in terms of improved imaging properties and diagnostic quality.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence:	The device (Aquilion PRIME, TSX-303A/A, 303A/B and 303A/F, v6.00) is determined to be substantially equivalent to the predicate device (Aquilion PRIME, TSX-303A/2 and 303A/6, v5.00, K130645). Modifications include a new detector that meets the specifications of the current detector and addition of previously cleared optional software features. The method of operation, base software, and manufacturing process remain unchanged.
Detector Performance:	The modified system's detector sensitivity and noise properties showed improvement in both studies.
Image Quality Metrics:	Additional image quality metrics (utilizing phantoms) demonstrated that the subject device is substantially equivalent to the predicate device with regard to spatial resolution, CT number, contrast-to-noise ratio, and uniformity performance.
Diagnostic Quality:	Representative diagnostic images (brain, chest, abdomen, peripheral exams) were obtained and reviewed, demonstrating that the device produces images of diagnostic quality and performs as intended.
Safety and Standards:	Conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020] and various IEC, NEMA, and internal quality system standards (e.g., IEC60601-1 series, ISO 13485, 21 CFR § 820). The device is concluded to be safe and effective for its intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated as a number of patients or cases. The document mentions "representative diagnostic images" but does not quantify them.
Data Provenance: Not specified. It's likely that the "representative clinical images" were obtained during internal testing or pilot sites, but no details on country or retrospective/prospective nature are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: "an American Board Certified Radiologist" (singular).
Qualifications of Experts: "American Board Certified Radiologist." No specific experience level (e.g., 10 years) is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: "Reviewed by an American Board Certified Radiologist." This implies a single reader review, so no adjudication method (like 2+1 or 3+1) was used.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a CT system itself, not an AI-assisted diagnostic tool designed to improve human reader performance. Its purpose is to demonstrate the fundamental image quality and safety of the CT scanner.

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

This is not applicable in the context of this submission. The device is a CT scanner, which inherently produces images for human interpretation. The "software options" mentioned (SEMAR, SURESubtraction Ortho, Dual Energy System Package) are image processing algorithms that enhance the raw CT data, but the "performance" as described (image quality metrics, diagnostic quality) still relates to the final image presented for a human in the loop. There is no "algorithm only" performance study in the sense of an automated diagnostic algorithm.

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

The "ground truth" for evaluating image quality appears to be based on:
- Phantom measurements: For spatial resolution, CT number, contrast-to-noise ratio, and uniformity performance.
- Expert opinion: The "American Board Certified Radiologist" reviewing representative diagnostic images for diagnostic quality. This functions as the human expert assessment indicating the images are fit for interpretation.

8. The sample size for the training set

Not applicable/provided. This document describes a new version of an existing CT scanner, not a novel machine learning algorithm that requires a separate training set. The "software options" mentioned were previously cleared and their development (including any training data if applicable) would have been part of their original 510(k) submissions.

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

Not applicable. See point 8.

Summary

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

November 26, 2014

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

Re: K141741

Trade/Device Name: Aquilion PRIME, v6.00 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 23, 2014 Received: October 24, 2014

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

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)

K141741

Device Name

Aquilion PRIME, TSX-303A/A, 303A/B and 303A/F, V6.00

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 Prime 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.

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

SUBMITTER'S NAME: 1. Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. 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:
  June 26, 2014
1. TRADE NAME(S):
  Aquilion PRIME, TSX-303A/A, 303A/B and 303A/F, v6.00

7. 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

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10. PERFORMANCE STANDARD:

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

11. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aquilion PRIME,TSX-303A/2 and 303A/6, v5.00	Toshiba AmericaMedical Systems	K130645	June 6, 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 Prime 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 subject device is substantially equivalent to the TSX-303A/2 and /6, Aquilion Prime CT System, K130645, marketed by Toshiba America Medical Systems. The Aquilion PRIME TSX-303A/A, 303A/B and 303A/F, v6.00, incorporates modifications to the cleared device which include implementation of a new detector that meets the specifications of the current detector and addition of previously cleared optional software features. The method of operation, base software and manufacturing process 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 TSX-303A/2 and 303A/6, Aquilion Prime CT System:

Item	Aquilion PRIME TSX-303A/A,303A/B and 303A/F, v6.00	Aquilion PRIMETSX-303A/2 and 303A/6, v5.00
510(k) Number	This submission	K130645
Detector	896 channels × 80 rows	896 channels × 80 rows
Number of detector elements	80 x 0.5 mm rows	80 x 0.5 mm rows
Maximum scan slice thickness	40mm/rotation	40mm/rotation
Console Operating System	Microsoft Windows 7	Microsoft Windows XP

Previously cleared software options being implemented to the modified device:

SEMAR (Single Energy Metal Artifact Reduction)	Previously cleared under K132222
SURESubtraction Ortho	Previously cleared under K130960
Dual Energy System Package	Previously cleared under K132813

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 to assess detector sensitivity and noise properties 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. 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.

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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 PRIME TSX-303A/A, 303A/B and 303A/F, v6.00 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.