suRESubtraction Ortho software is intended to generate subtraction images and improve the visualization of contrast enhancement. The system can load two or more CT images with and without contrast enhancement. When used by a qualified physician, a potential application is to determine the course of treatment.

Device Description

The SURESubtraction Ortho, CSSO-001A is a post-processing software that subtracts image information by comparison of two data sets, one of which is contrast enhanced. Registration software is used to match the two independent studies. This registration software has been used on Toshiba CT systems for a number of years with no adverse events reported.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and study for the SURESubtraction Ortho, CSSO-001A device:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device after a modification to an accessory software (SURESubtraction Ortho) to extend its anatomical region of use. The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics used in a formal clinical study. Instead, it describes general improvements and performance validation.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not presented in the provided document, the table below reflects what can be inferred from the "Testing" section and the claims of improvement.

Acceptance Criteria (Inferred)	Reported Device Performance
Ability to generate subtraction images.	"SURESubtraction Ortho, CSSO-001A, performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis."
Successful visualization of calculated enhanced edema in varying positions and rotations.	"Performance studies demonstrated that resultant subtraction images produced by the software can be used to successfully visualize calculated enhanced edema in varying positions and rotations."
Improved visualization of contrast enhancement compared to the predicate software.	"in comparing original CT images processed with SURESubtraction Ortho versus the predicate software, the resultant images demonstrate improved visualization." This is also stated in section 15: "Additionally, this software includes modifications that improve upon the visualization of contrast enhancement as demonstrated in the performance studies included in this submission."
Conformance to Quality System Regulations, ISO 13485, and applicable IEC standards (IEC62304, IEC62366, 21 CFR §1020).	"This 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 IEC62304 and IEC62366 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."
Software Documentation for Moderate Level of Concern per FDA guidance.	"Software Documentation for a Moderate Level of Concern, per the FDA guidance document... is also included as part of this submission."

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

The document states "performance studies" were conducted but does not specify the sample size for any test set (number of images, cases, or patients).

The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective). The nature of the testing described ("bench testing" and "resultant subtraction images produced by the software") suggests it could be based on existing or simulated data, rather than a prospective clinical trial.

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

The document does not specify the number of experts used to establish ground truth, nor does it provide their qualifications. The mention of "qualified physician" in the Indications For Use suggests clinical relevance, but details about expert review for the study are absent.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

The document does not describe an MRMC comparative effectiveness study. The study described focuses on the device's ability to produce subtraction images and improve visualization, not on human reader performance with or without the device. Therefore, no effect size of human improvement with AI assistance is provided.

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

Yes, the testing described appears to be a standalone (algorithm only) performance assessment. The text mentions "resultant subtraction images produced by the software" and an "improved visualization" when comparing software outputs to each other, without involving human interpretation performance as the primary endpoint. "Bench testing" is also mentioned, reinforcing this.

7. The Type of Ground Truth Used

The document implies a form of expert assessment or comparison to a gold standard, but it does not explicitly state the specific type of ground truth used. The claims of "successful visualization of calculated enhanced edema" and "improved visualization" suggest that there was a reference or standard against which the software's output was judged, likely by human observers or against a known expectation. However, it's not explicitly stated if this was pathology, outcomes data, or a formal expert consensus.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This submission is for a modification of existing software, and the discussion focuses on performance studies, not the original development or training of the core algorithm.

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

Since no training set details are provided, there is no information on how its ground truth was established.

Summary

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

K130960

: |

ГОВНІВА AMERICA MEDICAL БУSTEMS, INC.

2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-5000

510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

1. SUBMITTER'S NAME: Toshiba America Medical Systems, Inc.

1. ADDRESS: 2441 Michelle Drive Tustin, CA. 92780-2068
1. ESTABLISHMENT REGISTRATION: 2020563

AUG 2 0 2013

1. CONTACT PERSON: Paul Biggins Director, Regulatory Affairs (714) 730-5000
1. DATE PREPARED: July 25, 2013
1. TRADE NAME(S): suRESubtraction Ortho, CSSO-001A

7. COMMON NAME: System, X-ray, Computed Tomography

1. DEVICE CLASSIFICATION: Class II (per 21 CFR 892.1750)
1. PRODUCT CODE / DESCRIPTION: 90JAK - System, Computed Tomography
1. PERFORMANCE STANDARD: None

11. PREDICATE DEVICE:

Product	Marketed by	510(k) Number	Clearance Date
Aquilion ONE Vision,TSX-301c/1, v4.90	Toshiba AmericaMedical Systems	K122109	September 21, 2012

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

12. REASON FOR SUBMISSION:

Modification to an accessory software

13. DEVICE DESCRIPTION:

14. INDICATIONS FOR USE:

15. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to SURESubtraction, the subtraction tool used for Orbital Synchronized Scan System, CKOS-001A, which was originally cleared under the premarket notification for TSX-101A/H, /i, Aquilion 64/32 SP CT Scanner 510(k), K051833. Since this clearance all Toshiba CT systems have incorporated this post processing software; the latest clearance being on the Aquilion ONE Vision, TSX-301c/1, v4.90, K122109.

sureSubtraction Ortho includes modifications to the predicate software which improves on the anatomical region with which the software can be used. This post processing software performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis. Additionally, this software includes modifications that improve upon the visualization of contrast enhancement as demonstrated in the performance studies included in this submission.

	SURESubtraction,CKOS-001A	SURESubtraction Ortho,CSSO-001A
	Predicate device	Subject Device
Anatomical Region(CT Field Of View)	Head and neck region	Any body region containingbone

A summary of the changes is included below and in more detail within this submission.

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

	SURESubtraction,CKOS-001A	SURESubtraction Ortho,CSSO-001A
	Predicate device	Subject Device
TargetFor Subtraction	Bone andcalcifications close tovasculature	Bone
SubtractionAlgorithm	Subtraction of intensityvalues of registeredcontrast-enhanced andnon-contrasted pixels	Subtraction of intensityvalues of registeredcontrast-enhanced andnon-contrasted pixels

16. SAFETY:

This 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 IEC62304 and IEC62366 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.

17. TESTING

Risk analysis and performance testing conducted through bench testing are included in this submission. Performance studies demonstrated that resultant subtraction images produced by the software can be used to successfully visualize calculated enhanced edema in varying positions and rotations and that in comparing original CT images processed with SURESubtraction Ortho versus the predicate software, the resultant images demonstrate improved visualization.

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

SURESubtraction Ortho, CSSO-001A, performs in a manner similar to the predicate device in that subtraction images are created which aid in diagnosis. Based upon the data presented in this submission including conformance to standards, application of design controls and performance data, Toshiba America Medical Systems, believes that SURESubtraction Ortho, CSSO-001A, is substantially equivalent in safety and effectiveness to the predicate device.

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

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 20, 2013

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

Re: K130960/S001
Trade/Device Name: SURESubtraction Ortho CSSO-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Commuter Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: July 25, 2013 Received: July 26, 2013

Dear Mr. Paul 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

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

Page 2 - Mr. Paul Biggins

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.

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" (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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K130960 SURESubtraction Ortho_CSSO-001A

Device Name:

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

sinh 7)

北

510(k): K130960

Page 1 of __ 1__

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.