This device is a digital radiography/fluoroscopy system used in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and anqioqraphic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Device Description

INFX-8000V, V7.0, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm/Ω-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Infinix-i, INFX-8000V, V7.0, an image-intensified fluoroscopic x-ray system. The submission focuses on modifications to a previously cleared device (INFX-8000V, V6.35) and asserts substantial equivalence.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered:

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

The document does not explicitly state formal acceptance criteria with specific thresholds or provide a table of reported device performance against such criteria. Instead, it states that "test data demonstrates that the system modifications result in performance that is equal to or better than the predicate system." The evaluation was conducted through "System evaluation of image quality" and "Evaluation of items supported to improve image quality" using phantoms.

The improvements claimed are:

Feature/Improvement	Description of Improvement
Time Axis SNRF	Further reduces image noise with minimal lag by utilizing chronological frame data.
F-SUB (fluoroscopic subtraction)	Artifact reduction during fluoroscopic subtraction.
Real Time Auto Pixel Shift (RAPS)	Automatically corrects misalignment between contrast image and mask image during DSA and F-SUB acquisition.
Enhanced Live Zoom image quality
UNSUB DSA halation reduction	Enables evaluation of positional relationship between vessel and bone in the UNSUB (unsubtracted) display of the DSA image.
16-bit data processing	Maximizes FPD output data use.
Workflow Improvements	DFP supports up to four streams of display concurrently; reduction of steps and time during F-SUB sequence; reduction in processing time for system startup and map saving.
DFP (Digital Fluoroscopy Processor) Hardware Changes	Host system PC, real time controller CPU board, image processing unit, and storage changes to enhance operability and image quality.

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

The document mentions that testing was conducted through "bench testing" and "utilizing phantoms" for image quality metrics.

Sample size: Not specified. The term "phantoms" suggests artificial test objects rather than patient data.
Data provenance: Not specified, but given the use of phantoms and bench testing, it's likely laboratory-generated data. There is no mention of patient data, clinical studies, country of origin related to patient data, or whether it was retrospective or prospective.

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)

This information is not provided in the document. The testing described focuses on objective image quality metrics using phantoms, not on human expert interpretation of clinical images to establish ground truth.

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

This information is not provided as the testing method described does not involve human adjudication of clinical cases.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any indication that the device incorporates AI or is intended to assist human readers in image interpretation. The device is described as an "Image-intensified fluoroscopic X-ray system" with improvements to image processing and hardware.

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

The document describes "System evaluation of image quality" and "Evaluation of items supported to improve image quality" utilizing phantoms. This suggests standalone technical performance testing of the device's image output, without a human in the loop for interpretation in a clinical context. However, it's not an "algorithm only" performance in the sense of an AI model, but rather the performance of the complete imaging system.

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

Given the reliance on "phantoms" for image quality metrics, the "ground truth" would be the known and controlled characteristics of the phantoms themselves (e.g., specific spatial resolution patterns, contrast levels, signal-to-noise ratios). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth.

8. The sample size for the training set

This information is not provided. The document describes an update to an existing X-Ray system, not the development of a machine learning or AI algorithm that typically requires a 'training set'.

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

This information is not provided as there is no mention of a training set or machine learning algorithms in the document.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2017

Toshiba Medical Systems Corporation % Ms. Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K172863

Trade/Device Name: Infinix-i, INFX-8000V, V7.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB Dated: September 20, 2017 Received: September 20, 2017

Dear Ms. Reyes:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Reset Form

Indications for Use

510(k) Number (if known)

K172863

Device Name

Infinix-i, INFX-8000V, V7.0

Indications for Use (Describe)

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

Y Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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

Image /page/3/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is stacked on top of the word "MEDICAL". Both words are in a bold, sans-serif font and are colored red. The logo is simple and clean, with a focus on the company name.

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92

1. CLASSIFICATION and DEVICE NAME

Classification Name	Image-intensified fluoroscopic X-ray system
Primary Product Code	OWB
Regulation Number	21 CFR 892.1650
Regulatory Class	Class II
Trade Proprietary Name/Model Number	Infinix-i, INFX-8000V, V7.0

2. SUBMITTER'S NAME

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance Department

4. CONTACT PERSON, U.S. AGENT and ADDRESS

Contact Person

Janine Reyes Manager, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7853 Fax: (714) 730-1310 jfreyes@tams.com

5. MANUFACTURING SITE

Toshiba Medical Systems Corporation (TMSC) 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan

1. ESTABLISHMENT REGISTRATION 9614698
1. DATE PREPARED September 20, 2017
1. DEVICE MODEL NAME INFX-8000V, V7.0 [Infinix CF-i/SP, Infinix CF-i/BP, Infinix VF-i/SP, Infinix VF-i/BP]

Official Correspondent/U.S. Agent

Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 730-7808 Fax: (714) 730-1310 pbiggins@tams.com

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

Image /page/4/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is in large, bold, red letters on the top line. Below that, the word "MEDICAL" is in a smaller, bold, red font. The logo is simple and clean, with a focus on the company name.

9. TRADE NAME

Infinix-i, INFX-8000V, V7.0

10. DEVICE NAME

Interventional Fluoroscopic X-ray System

11. CLASSIFICATION PANEL

Radiology

12. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.1650)

13. PRODUCT CODE / DESCRIPTION

Product Code: OWB - Image-intensified fluoroscopic X-ray system

14. PERFORMANCE STANDARD

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].

15. PREDICATE DEVICE

Infinix, INFX-8000V, V6.35 (K162614)

Product	Marketed by	510(k) Number	Clearance Date
INFX-8000V, V6.35	Toshiba America Medical Systems	K162614	October 17, 2016

PREDICATE DEVICE CLASSIFICATION and DEVICE NAME

Regulation Description	Image-Intensified Fluoroscopic X-ray System
Regulation Number	21 CFR 892.1650
Regulatory Class	Class II
Primary Product Code	OWB

16. REASON FOR SUBMISSION

Modification of a cleared device

17. SUBMISSION TYPE

Traditional 510(k)

18. DEVICE DESCRIPTION

19. INDICATIONS FOR USE

This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

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

Image /page/5/Picture/0 description: The image shows the logo for Toshiba Medical. The word "TOSHIBA" is written in a bold, sans-serif font in red color. Below "TOSHIBA", the word "MEDICAL" is written in a similar font and color, but slightly smaller in size. The logo has a clean and professional look.

20. SUMMARY OF CHANGE(S)

This submission is to report image quality improvements, workflow improvements, and DFP (Digital Fluoroscopy Processor) hardware changes.

Image Quality Improvements: ●
- o Time Axis SNRF: Improvement to SNRF processing. Utilizing chronological frame data, image noise is further reduced with minimal lag.
- o F-SUB (fluoroscopic subtraction) improvement: artifact reduction during fluoroscopic subtraction.
- o Real Time Auto Pixel Shift (RAPS): Real Time Auto Pixel Shift automatically corrects misalignment between the contrast image and mask image during DSA and F-SUB acquisition.
- o Enhanced Live Zoom image quality
- o UNSUB DSA halation reduction: enables the ability to evaluate positional relationship between vessel and bone in the UNSUB (unsubtracted) display of the DSA image.
- o 16-bit data processing: maximized FPD output data use.
Workflow Improvements:
- o DFP supports the concurrent operation of up to four streams of display (three streams dynamic display plus export).
- o Reduction of steps and time during F-SUB sequence.
- o Reduction in processing time for both system startup and map saving.

● DFP (Digital Fluoroscopy Processor):

o Hardware changes to enhance both system operability and image quality. Changes include: host system PC, real time controller CPU board, image processing unit and storage.

21. 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, its collateral standards and particular standards; IEC 60601-2-43 and IEC60601-2-28. 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.

LIST OF APPLICABLE STANDARDS

. IEC60601-1:2005
. IEC60601-1-2:2007
. IEC60602-1-3: 2008
IEC60601-1-6: 2010
IEC60601-2-28: 2010
. IEC60601-2-43:2010
. IEC62304:2006
IEC62366:2007

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Toshiba Medical. The logo is in red and consists of two words, "TOSHIBA" on top of "MEDICAL". The font is bold and sans-serif.

22. TESTING

Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met.

System evaluation of image quality:

Image quality metrics were performed, utilizing phantoms, to asses spatial resolution, low-contrast resolution/dynamic range, fluoroscopic still image resolution/dynamic image resolution/afterimage, artifacts/contrast/dynamic range of DSA, reconstructed image spatial resolution in 3D-DA acquisition, reconstructed image spatial resolution in 3D-DSA acquisition, reconstructed image spatial resolution in 3D-LD acquisition, reconstructed image density resolution in LCI acquisition.

Evaluation of items supported to improve image quality:

Image quality metrics were performed, utilizing phantoms, to asses image quality improvements, DSA halation reduction, fluoroscopic subtraction artifact reduction, Live Zoom interpolation method comparison, SNRF noise reduction improvement comparison, real-time auto pixel shift comparison, 16-bit data LCI image reconstruction improved visualization comparison.

This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system. Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems.

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.

Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices " issued on October 2, 2014, is also included as part of this submission.

Additionally, the design controls used for this device included risk management and all known risks were mitigated to an acceptable level.

23. SUBSTANTIAL EQUIVALENCE

This device is substantially equivalent to the INFX-8000V, V6.35, (K162614), marketed by Toshiba America Medical Systems. INFX-8000V, V7.0, includes image quality improvements, Time Axis SNRF, F-SUB improvement, Real Time Auto Pixel Shift, enhanced live zoom image quality, UNSUB DSA halation reduction, 16-bit data processing, workflow improvements, and DFP hardware changes (host system PC, real time controller CPU board, image processing unit

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the words "TOSHIBA MEDICAL" stacked on top of each other. The words are in a bold, sans-serif font and are colored red. The word "TOSHIBA" is on the top line, and the word "MEDICAL" is on the second line. The background is white.

and storage). The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. There are no new indications for use or intended use of the device.

24. CONCLUSION

The subject device, INFX-8000V, V7.0, is substantially equivalent to the INFX-8000V, V6.35, which was cleared via Pre-Market Notification 510(k), K162614. The INFX-8000V, V7.0, incorporates modifications to the cleared device which include image quality improvements, Time Axis SNRF, F-SUB improvement, Real Time Auto Pixel Shift, enhanced live zoom image quality, UNSUB DSA halation reduction, 16-bit data processing, workflow improvements, and DFP hardware changes (host system PC, real time controller CPU board, image processing unit and storage). The changes to this device do not alter the indications for use or the intended uses associated with the previously cleared device, as described in the labeling. It is the contention of Toshiba that all new safety issues have been addressed in the design of this change and that adequate evidence of this is presented with this submission.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.