Adaptive Motion Correction (AMC) software is intended to be used as an adjunct to the current cardiac reconstruction methods in cases where motion of the coronary arteries creates artifacts. This software can be applied to these images, without additional dose to the patient, to enhance the visibility of the coronary arteries.

4D Airways Analysis is a post processing software that may be used in conjunction with chest CT images to provide automatic (semi-automatic) segmentation of the bronchial tree. This software may aid in the diagnosis and follow-up treatment of bronchial diseases.

Device Description

Adaptive Motion Correction (AMC), CSMC-001A, is a reconstruction method available on 320 row Aquilion ONE CT systems, which have system software V7.0 or later installed, to aid physicians in analysis of CT coronary angiography images for diagnosis and treatment planning.

4D Airways Analysis, CSAA-001A, is a post-processing software used on 320 row Aquillion ONE CT systems, which have system software V7.0 or later installed, to aid physicians in analysis of chest CT images for diagnosis and treatment planning.

AI/ML Overview

The provided text describes two software features: Adaptive Motion Correction (AMC) and 4D Airways Analysis. Since the details for each are somewhat distinct, I will present the information separately where appropriate.

Adaptive Motion Correction (AMC), CSMC-001A

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Improved visualization of coronary arteries	Demonstrated improved visualization of the coronary arteries with the exception of RCA (Right Coronary Artery).

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

Test Set Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated, though referred to as "clinical evaluations." It's common for such evaluations to use retrospective data from existing patient scans.

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

Number of Experts: Not explicitly stated, described as "qualified users."
Qualifications of Experts: "Qualified users" - specific qualifications (e.g., radiologist with X years of experience) are not provided.

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

Adjudication Method: Not explicitly stated. The text only mentions "clinical evaluations were performed by qualified users."

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: Not explicitly stated as an MRMC study. The evaluation focused on improved visualization, which can be part of qualitative MRMC-like assessments, but the methodology is not detailed enough to confirm.
Effect Size: Not provided.

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

Standalone Performance: Not explicitly stated. The description implies that the software is used as an "adjunct," suggesting human-in-the-loop, where AMC enhances images for physician review.

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

Type of Ground Truth: The improved visualization was likely based on subjective expert assessment (clinical evaluation by qualified users) of image quality and artifact reduction, rather than a definitive "ground truth" like pathology for diagnosis.

8. The sample size for the training set:

Training Set Sample Size: Not provided.

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

Ground Truth Establishment (Training Set): Not provided.

4D Airways Analysis, CSAA-001A

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Reduce user variability in measurements	Demonstrated that the user variability associated with this type of measurement was reduced.
Provide automatic (semi-automatic) segmentation of the bronchial tree	Yes (implied by device description)

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

Test Set Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated, though referred to as "clinical evaluations." It's common for such evaluations to use retrospective data from existing patient scans.

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

Number of Experts: Not explicitly stated, described as "qualified users."
Qualifications of Experts: "Qualified users" - specific qualifications are not provided.

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

Adjudication Method: Not explicitly stated. The text only mentions "clinical evaluations were performed by qualified users."

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: Not explicitly stated as an MRMC study. The evaluation focused on "reduced user variability," which suggests a quantitative assessment that might involve multiple readers, but the methodology is not detailed enough to confirm an MRMC study or an effect size for human reader improvement with AI assistance.
Effect Size: Not provided.

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

Standalone Performance: The software provides "automatic (semi-automatic) segmentation." While the core segmentation might be algorithmic, the assessment focused on "user variability associated with this type of measurement," suggesting human interaction and measurement following the segmentation. It does not explicitly describe a standalone algorithm-only performance assessment against a ground truth without human interaction.

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

Type of Ground Truth: The reduction in user variability implies a comparison of measurements made by different users, possibly against a reference measurement or an agreed-upon standard for bronchial tree segmentation and measurement. This would likely involve expert consensus or established anatomical landmarks/measurements.

8. The sample size for the training set:

Training Set Sample Size: Not provided.

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

Ground Truth Establishment (Training Set): Not provided.

General Notes for Both Devices:

The document is a 510(k) summary, which provides a high-level overview for substantial equivalence. It is not typically a detailed scientific publication. As such, many specific methodological details common in research papers (like exact sample sizes, detailed ground truth establishment, or specific expert qualifications) are often not included.
The emphasis in a 510(k) is on demonstrating substantial equivalence to a predicate device and safety/effectiveness rather than a comprehensive efficacy trial.
"Verification/validation and performance testing conducted through bench testing" and "Software Documentation for a Moderate Level of Concern" were also part of the submission, indicating adherence to general software development and testing standards.

Summary

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

May 15, 2015

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

Re: K143294

Trade/Device Name: Adaptive Motion Correction, CSMC-001A and 4D Airways Analysis. CSAA-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 23, 2015 Received: April 24, 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

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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.

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,

Hole 2. Mild

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)

K143294

Device Name

Adaptive Motion Correction (AMC), CSMC-001A, and 4D Airways Analysis, CSAA-001A

Indications for Use (Describe)

4D Airways Analysis is a post processing software that may be used in conjunction with chest CT images to provide automatic (semi-automatic) seqmentation of the bronchial tree. This software may aid in the diaqnosis and follow-up treatment of bronchial diseases.

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

ك 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:

January 9, 2015 (Updated May 12, 2015)

6. TRADE NAME(S):

Adaptive Motion Correction (AMC) and 4D Airways Analysis

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

10. PERFORMANCE STANDARD:

None

11. PREDICATE DEVICES:

Product	Marketed by	510(k) Number	Regulation Reference	Product Code	Clearance Date
THORACIC VCAR	GE Healthcare	K103480	21 CFR 892.2050	90LLZ	March 7, 2011
CardIQ Xpress 2.0 withSnapShot Freeze Option	GE Healthcare	K120910	21 CFR 892.1750	90JAK	June 18, 2012

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12. REASON FOR SUBMISSION:

New software applications intended to be used with 510(k) cleared Aquillion ONE CT systems which have system software V7.0 or later installed.

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

Adaptive Motion Correction (AMC) is substantially equivalent to and performs in a manner similar to CardIQ Xpress 2.0 with SnapShot Freeze Option, with regard to motion correction (both devices are intended to reduce coronary artery motion blurring) and anatomical region of use. 4D Airways Analysis is substantially equivalent to and performs in a manner similar to the predicate device, Thoracic VCAR, in that both devices may be used to provide segmentations of the airways and to display various measurements including luminal area/diameter, bronchial area and wall area.

Item	Adaptive Motion Correction(AMC)	CardIQ Xpress 2.0 withSnapShot Freeze Option
510(k) Number	This submission	K103480
Anatomical region(CT field of view)	Cardiac	Cardiac
Segmentation area	Coronary arteries	Coronary arteries
Motion estimationparameter	Motion path	Motion path and velocity of thecoronary arteries
Registration formotion estimation	Non-rigid registration	Non-rigid registration

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Item	4D Airways Analysis	Thoracic VCAR
510(k) Number	This submission	K120910
Anatomical region(CT field of view)	Chest	Chest
Target formeasurement	Airways	Airways and lungs
Target forInput data	Multiple volumes	Single volume
Measurement	Lumen diameter and wall area	Lumen diameter and wall area

16. SAFETY:

The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC62366.

17. TESTING

Hazard analysis, verification/validation and performance testing conducted through bench testing are included in this submission which demonstrates that the design specifications established for the device have been met.

For both software features clinical evaluations were performed by qualified users to ensure that the final images presented met user needs. The clinical evaluation of the Adaptive Motion Correction software demonstrated improved visualization of the coronary arteries with the exception of RCA. The clinical evaluation of the 4D Airways Analysis software demonstrated that the user variability associated with this type of measurement was reduced.

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.

18. CONCLUSION

Adaptive Motion Correction (AMC) and 4D Airways Analysis, perform in a manner similar to and are intended for similar use as the predicate devices. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.

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.