The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-i series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedures for the whole body (includes heart, chest, abdomen, brain and extremity).

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angrography procedures for the heart, chest, abdomen, pelvis and brain.

Device Description

The XIDF-AWS801 Angio Workstation is used for images input from Diagnostic lmaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the XIDF-AWS801, Angio Workstation, v5.31, based on the provided FDA 510(k) summary:

This device (XIDF-AWS801, Angio Workstation, v5.31) is a modification of a previously cleared device (XIDF-AWS801, Angio Workstation w/Dose Tracking System, K132106). The changes are specifically related to the Dose Tracking Software, expanding it to provide estimated skin dose for the head and improving simultaneous tracking of dual tubes.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the Dose Tracking System's performance in K141541. Instead, it states:

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Dose Tracking Performance	"Testing was performed to verify the estimated dose displayed by the software with the actual measured dose on the phantom within the gantry field of exposure."	"Testing has verified that the changes perform as intended."
Safety and Effectiveness	"The modifications incorporated into the XIDF-AWS801, v5.31, do not change the indications for use or the intended use of the device."	"Safety and effectiveness have been verified via risk management and application of design controls to the modifications."
Conformance	"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 IEC standards."	(Implied through continued manufacturing and design controls to these standards)

Key Observation: The summary focuses on verifying that the changes (expansion to head dose estimation and dual-tube tracking) perform as intended and do not negatively impact the established safety and effectiveness of the predicate device. There are no specific quantifiable performance metrics provided for the estimated dose compared to actual measured dose.

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

Sample Size: Not explicitly stated. The document mentions "commercially available phantom and measurement tools" but does not quantify the number of phantoms, tests, or data points used in the testing.
Data Provenance: The testing was "performed using commercially available phantom and measurement tools." This indicates that the data is prospective (generated specifically for this testing) and likely collected in a controlled laboratory or testing environment, rather than from patient data. The country of origin for the data is not specified, but the manufacturing site is in Japan (Toshiba Medical Systems Corporation).

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

Number of Experts: Not applicable/Not stated. The ground truth for the dose estimation was established by "actual measured dose on the phantom within the gantry field of exposure," implying physical measurement rather than expert interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth was based on physical measurements, not expert consensus requiring adjudication.

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. This device is a dose tracking system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The primary function is to provide an estimated skin dose for dose management.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, in essence, the testing described appears to be a standalone performance evaluation of the algorithm's ability to estimate dose against physical measurements. The "estimated dose displayed by the software" was compared against "actual measured dose on the phantom."

7. The Type of Ground Truth Used

Type of Ground Truth: Physical measurement/reference standard. Specifically, the "actual measured dose on the phantom within the gantry field of exposure."

8. The Sample Size for the Training Set

Sample Size: Not stated. The document describes a "modification of a cleared device" and implies that the dose tracking software is based on physical models and algorithms rather than machine learning that requires a "training set" in the traditional sense of AI. If machine learning was involved, this information is not provided. The testing focused on validating the modified software behavior.

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

How Ground Truth for Training Set Was Established: Not applicable/Not stated. Given the nature of a dose tracking system, it's more likely based on established physics and calibration models than a "training set" with ground truth in the context of image recognition. If the original development of the dose tracking algorithms involved data-driven training, this information is not present in the provided summary focusing on the modification of an already cleared device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

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

September 8, 2014

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

Re: K141541

Trade/Device Name: XIDF-AWS801, Angio Workstation, v5.31 Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: June 9, 2014 Received: June 10, 2014

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. 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.

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

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.

Smh.7)

for

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141541

Device Name XIDF-AWS801; Angio Workstation v5.31

Indications for Use (Describe)

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angrography procedures for the heart, chest, abdomen, pelvis and brain.

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

X 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)

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

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."

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

510(k) - SUMMARY OF SAFETY AND EFFECTIVENESS

1. CLASSIFICATION and DEVICE NAME:

Classification Name:	Picture archiving and communications system,
Regulation Number:	21 CFR 892.1650 (Class II)
Product Code	JAA – Image Processing/WorkStation
Trade Proprietary Name:	XIDF-AWS801, Angiography Workstation
Model Number:	XIDF-AWS801 V5.31

2. ESTABLISHMENT REGISTRATION: 9614698

3. CONTACT PERSON, U.S. AGENT and ADDRESS:

Contact/U.S. Agent:

Paul Biggins Director, Regulatory Affairs (714) 730-5000 Fax: (714) 730-1310 pbiggins@tams.com

Establishment Name and Address:

Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, Ca. 92780

4. MANUFACTURING SITE

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

1. Date OF SUBMISSION: June 9, 2014
1. PERFORMANCE STANDARD: 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

7. PREDICATE DEVICE:

XIDF-AWS801. Angio Workstation (K132106)

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

8. REASON FOR SUBMISSION:

Modification of a cleared device

9. SUBMISSION TYPE:

Traditional 510(k)

10. DEVICE DESCRIPTION:

11. SUMMARY OF INTENDED USES:

The Angio Workstation (XIDF-AWS801) is used in combination with an interventional angiography system (Infinix-I series systems and INFX series systems) to provide 2D and 3D imaging in selective catheter angiography procedure for the whole body (includes heart, chest, abdomen, brain and extremity.)

When XIDF-AWS801 is combined with Dose Tracking System (DTS), DTS is used in selective catheter angiography procedure for the heart, chest abdomen, pelvis and brain.

12. SUMMARY OF CHANGE(S)

Dose Tracking Software has been expanded to provide estimated skin dose for the head. Additionally, the software has been improved over the previous versions to allow simultaneous tracking of dual tubes in bi-plane and dual plane operations.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the XIDF-AWS801, Angio Workstation w/Dose Tracking System (K132106), marketed by Toshiba America Medical Systems. XIDF-AWS801 (v5.31) includes modifications to the cleared device which includes improvements to the Dose Tracking System. Testing, which conforms to the testing of the predicate device, has been performed to verify the additions to the software do not affect the effectiveness of the performance. This software is a dose management tool and as such does not provided an indicated use. The intended use of the device and predicate remain the same, to provide an estimated skin dose in real time during angiography procedures.

14. 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 IEC standards.

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

15. TESTING

Testing has been performed using commercially available phantom and measurement tools. The testing was performed to verify the estimated dose displayed by the software with the actual measured dose on the phantom within the gantry field of exposure.

16. CONCLUSION

The modifications incorporated into the XIDF-AWS801, v5.31, do not change the indications for use or the intended use of the device. Safety and effectiveness have been verified via risk management and application of design controls to the modifications. Testing has verified that that the changes perform as intended.

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.