The Aquilion RXL 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 TSX-101A/R is a whole body CT scanner. This device captures helical volumetric data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a CT scanner (Aquilion RXL; TSX-101A) by Toshiba America Medical Systems, Inc. The submission is for a modification to a cleared device (TSX-301A/2 - K093891), specifically to reduce radiation exposure to the patient using an iterative reconstruction algorithm (AIDR algorithm).

However, the document does not provide specific acceptance criteria, detailed study results, or the other requested granular information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) that would typically be found in a comprehensive clinical study report. The submission focuses on demonstrating substantial equivalence based on the device's design, manufacturing controls, and general performance testing using phantoms, rather than detailed clinical validation with specific endpoints.

Here's a breakdown of what can be extracted from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Implicit Criteria: Reduction in radiation exposure while maintaining diagnostic image quality.	The modification "allows for the use of an iterative reconstruction algorithm that provides the user the ability to perform scans at lower doses." Image quality metrics were evaluated using phantoms and "clinical data" was gathered from beta sites for software validation.
Compliance with safety standards (e.g., IEC60601-1, 21 CFR §1020).	Device is "in conformance with the applicable parts of the IEC60601-1 standards and its collateral standards." "All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report."
No change to Intended Use/Indications for Use.	"The additional features that are being added to the Aquilion RXL at this time do not change the indication for use or the intended use of the device."

Study Proving Acceptance Criteria:

The document states: "Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device. Additional testing was conducted at numerous beta sites to provide clinical data for the validation of the software change."

This implies that the "study" involved:

Phantom Testing: To verify image quality metrics with the new iterative reconstruction algorithm.
Beta Site Clinical Data: To validate the software change in a clinical setting, presumably to confirm that the lower-dose scans with AIDR produce clinically acceptable images.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "numerous beta sites" for clinical data, but no specific number of patients or scans.
Data Provenance: The "clinical data" was gathered at "numerous beta sites," which suggests a prospective collection for validation, but the country of origin is not specified. The submitting company, Toshiba America Medical Systems, Inc., is based in Tustin, CA, USA, which might suggest US-based beta sites, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified. The document mentions that the volume sets "can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician." This refers to the general use of the device, not specifically the establishment of ground truth for the validation study of the AIDR algorithm. There is no information on how many experts, or their qualifications, were involved in assessing the clinical data from the beta sites.

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

Not specified. The document does not provide any details on adjudication methods for the clinical data collected.

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

Not specified and unlikely. The AIDR algorithm is an iterative reconstruction technique, which is a core image processing function of the CT scanner, not typically an AI-assisted diagnostic tool that would directly lead to "human readers improve with AI vs without AI assistance" in the way an MRMC study evaluates. The focus here is on achieving image quality comparable to higher-dose scans. The document does not mention any MRMC study or effect sizes of human reader improvement.

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

Implicitly, yes for image quality metrics. The "testing was conducted utilizing phantoms and accepted image quality metrics" would represent a standalone performance evaluation of the algorithm's effect on image characteristics (e.g., noise, spatial resolution, contrast-to-noise ratio) without human interpretation initially. However, the exact metrics and results are not detailed. The beta site data would then involve human observers (physicians) assessing clinical utility.

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

Not explicitly stated. For the clinical validation at beta sites, the "ground truth" would likely be the clinical assessment by trained and qualified physicians of the diagnostic utility of the lower-dose images generated with AIDR compared to standard-dose images (or the previous version of the device). This implicitly relies on clinical judgment and potentially comparison with the previous standard, but no specific external ground truth (like pathology or outcomes) is mentioned.

8. The sample size for the training set

Not applicable/Not specified. AIDR is described as an "iterative reconstruction algorithm." While such algorithms can sometimes be machine learning-based, the document doesn't explicitly state it's a "deep learning" or AI model that requires a distinct "training set" in the modern sense. If it did involve such a training set, the sample size is not specified. It's more likely to be a sophisticated mathematical reconstruction technique rather than a data-trained AI model in this context (given the 2012 submission date).

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

Not applicable/Not specified. As above, a "training set" and its "ground truth" establishment are not discussed in the context of this iterative reconstruction algorithm.

Summary

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

K.121553

Toshiba America Medical Systems, Inc. · Pre-Market Notification 510(k) TSX-301A/2 Aquilion ONE w/4.74ER Software

und... a

510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 26 2012

, 그

ﺎ ﺍﻟ

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. TRADE NAME(S): TSX-101A/R; Aquilion RXL
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
1. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard
1. PREDICATE DEVICE: TSX-301A/2 - K093891
1. REASON FOR SUBMISSION: Modification of a cleared device

12. DEVICE DESCRIPTION:

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

1011 311188 Mar. El 110

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) TSX-301A/2 Aquilion ONE w/4.74ER Software

13. SUMMARY OF INTENDED USES:

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

. I(K)

The Aquilion RXL 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.

14. SUBSTANTIAL EQUIVALENCE:

The modification to this device is to reduce radiation exposure to the patient. The modification allows for the use of an iterative reconstruction algorithm that provides the user the ability to perform scans at lower doses. The materials, hardware, method of operation, base software and manufacturing processes remain unchanged from the cleared device: TSX301A/2 (K093891).

New feature
Maximum number of slices	Changed from 16 to 32
Application of AIDR algorithm	Not available on previous version
Active Collimation	Not available on previous version.
Improved ComputationalHardware	Updated computer and associatedhardware from previous version.

15. 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 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via product report.

16. SUMMARY OF TESTING:

Testing was conducted utilizing phantoms and accepted image quality metrics. The results of this testing is contained in the user information for the device. Additional testing was conducted at numerous beta sites to provide clinical data for the validation of the software change.

Page 2 of 3

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

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) Market Notification 11 in 1 TSX-301A/2 Aquilion ONE w/4.74ER Software ヘッド・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

17. CONCLUSION

The additional features that are being added to the Aquilion RXL at this time do not change the indication for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to this modification.

Page 3 of 3

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

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 26 2012

Toshiba Medical Systems Corporation % Mr. Paul Biggins Director Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K121553

Trade/Device Name: Aquillion RXL; TSX-101A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 24, 2012 Received: May 25, 2012

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 aird 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The FD F in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

1 - 8 -

Indications for Use Form

510(k) Number (if known): _

Device Name: Aquillion RXL; TSX-101A

Indications for Use:

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

The Aquilion RXL 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 Prescription Use
(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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Muhal D. O'Brien

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121553

Page 1 of

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.