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 angiography 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

This document is a 510(k) premarket notification for the Toshiba Medical Systems Corporation's XIDF-AWS801, Angio Workstation, v5.31. It describes an update to an existing device rather than a de novo submission. Therefore, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the same way a new device with novel claims would.

However, based on the provided text, I can infer and extract some information relevant to your request, particularly regarding the additional software features introduced in this version (Left Atrium Segmentation, Parametric Images, and MAR – Metal Artifact Reduction). The document states that "Testing was performed using archived clinical images, simulation testing and bench (phantom) testing."

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided in this 510(k) summary:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the new software features. The overarching "acceptance criterion" for this 510(k) submission is that the modifications (new software features) retain the safety and effectiveness of the cleared predicate device.

Feature / Criterion	Reported Device Performance
New Software Features
Left Atrium Segmentation (automatic segmentation)	Testing (using archived clinical images, simulation, and bench testing) verified that the performance of the changes was within specified requirements and that the modifications retained the safety and effectiveness of the cleared device. (Specific quantitative performance metrics like accuracy, sensitivity, or precision are not provided in this summary.)
Parametric Images	Testing (using archived clinical images, simulation, and bench testing) verified that the performance of the changes was within specified requirements and that the modifications retained the safety and effectiveness of the cleared device. (Specific quantitative performance metrics are not provided.)
MAR (Metal Artifact Reduction)	Testing (using archived clinical images, simulation, and bench testing) verified that the performance of the changes was within specified requirements and that the modifications retained the safety and effectiveness of the cleared device. (Specific quantitative performance metrics are not provided.)
Overall Device Safety and Effectiveness	The device modifications do not change the indications for use or intended use. Safety and effectiveness have been verified via risk management and application of design controls. Testing has verified that the changes perform as intended and include user information related to their performance. The device is substantially equivalent to the predicate.

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

Sample Size: Not specified in the summary. The text mentions "archived clinical images" and "data sets."
Data Provenance: The data used for testing included "archived clinical images" as well as "simulation testing and bench (phantom) testing." The country of origin for the clinical images is not specified. "Archived clinical images" suggests the data was retrospective.

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 summary. Given the context of a 510(k) amendment for new software features that are "not intended for stand-alone use or diagnosis" but rather to provide "information that is to be used in adjunct to the normal images," it's possible that formal expert consensus for ground truth on a large test set was not a primary focus for this specific submission's documented testing, or the details were not included in the public summary.

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

This information is not provided in the summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the summary. The document focuses on the technical performance verification of the new features and their substantial equivalence, not on human reader performance with or without the device. The new software is explicitly stated as "not intended for stand-alone use or diagnosis" and is instead "to provide the user with information that is to be used in adjunct to the normal images."

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

Yes, testing was done on the algorithms (the new software features). The summary states "Testing was conducted using bench (phantom) tests, simulations and archived images data sets. The results of this testing verified that the performance of the changes was within the specified requirements." This indicates a standalone evaluation of the software's output, as distinct from evaluating human performance. However, it also states the software is "not intended for stand-alone use or diagnosis."

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

The specific type of ground truth for the "archived clinical images" is not specified. For bench and simulation testing, the 'ground truth' would typically be defined by the known parameters of the phantom or simulated data.

8. The sample size for the training set

This information is not provided in the summary. The document mentions "archived clinical images" were used for testing, but it doesn't discuss a separate training set for the development of the algorithms.

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

Since a training set size or its use isn't specified, how its ground truth was established is also not provided.

Summary

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

March 11, 2015

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: K142736

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: OWB, JAA Dated: January 13, 2015 Received: February 18, 2015

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.

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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,

Robert A Ochs

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) K142736

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 angiography procedures for the heart, chest, abdomen, pelvis and brain.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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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	OWB, JAA
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:
  September 22, 2014

6. PERFORMANCE STANDARD:

21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard

7. PREDICATE DEVICE:

XIDF-AWS801. Angio Workstation (K141541)

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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)

This submission is to report the addition of several post-processing software applications which are meant to provide the user with information that is to be used in adjunct to the normal images provided by the Angio System. These software packages in Left Atrium Segmentation (automatic segmentation), Parametric Images and MAR (Metal Artifact Reduction) software. All of these features are intended for use with existing imaging from the cleared device. The software are not intended for stand-alone use or diagnosis.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the XIDF-AWS801, Angio Workstation w/ Dose Tracking System (K141541), marketed by Toshiba America Medical Systems. XIDF-AWS801 (v5.31) includes additional software features. The additional software features have the same intended use as the secondary predicate devices, listed below in table one. Testing was performed using archived clinical images, simulation testing and bench (phantom) testing. This testing demonstrated that the implementation of the modifications retained the safety and effectiveness of the cleared device.

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510(k) Number	Clearance Date	Device Name	Manufacturer
K141541Primary Predicate	9/8/2014	Angio Workstationv5.31	Toshiba MedicalSystems
K132222Secondary Predicate	11/7/2013	Aquilion ONE Vision	Toshiba MedicalSystems
K023760Secondary Predicate	11/22/2002	Cardiac FunctionalAnalysis Software	Toshiba MedicalSystems
K110834Secondary Predicate	4/26/2011	AW Volume Share 5with Angio Viz Option	GE Healthcare

Table 1: Predicate Devices

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.

15. TESTING

Testing was conducted using bench (phantom) tests, simulations and archived images data sets. The results of this testing verified that the performance of the changes was within the specified requirements. Additionally, the testing was used to include user information related to the performance of the changes.

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.

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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.