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

Device Description

The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation.

AI/ML Overview

Please note that the provided text is a 510(k) summary for a medical device (Angio Workstation) and primarily focuses on demonstrating substantial equivalence to a predicate device due to minor software changes. It does not contain a detailed clinical study demonstrating the performance of an AI algorithm against specific acceptance criteria in the way a new, high-risk AI device submission typically would.

The only AI-related change mentioned is the improvement to the "Dynamic Device Stabilizer (DDS) software with deep learning" to "improve the detection rate of the stent marker." The document states "Testing was conducted to verify the fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm for Dynamic Device Stabilizer (DDS)..." However, it does not provide the specifics of this test in terms of acceptance criteria, sample size, or ground truth establishment relevant to an AI model's performance as you've requested. It implies that the test was a "bench test" and verified "fixed display performance," which is more aligned with system-level performance rather than the diagnostic performance of an AI.

Therefore, I cannot fully answer your request based on the provided text, as it lacks the detailed AI study information you've asked for.

However, I can extract the limited information present and highlight what is missing.

Acceptance Criteria and Device Performance (Limited Information)

The document mentions that the DDS software with deep learning was changed to "improve the detection rate of the stent marker" and that "Testing was conducted to verify the fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm."

Missing Information:

Specific quantitative acceptance criteria for "detection rate of the stent marker" (e.g., minimum sensitivity, precision, F1-score).
The actual reported performance metric for the stent marker detection by the V9.5 algorithm.
The definition of "fixed display performance" in quantitative terms and its relationship to the deep learning component's performance.

Given the limited information, a table of acceptance criteria and reported device performance cannot be fully constructed as requested. The document only broadly states "performance was improved" without quantitative metrics.

Study Details (Based on Available Information)

As the document only mentions an improvement to an existing feature (DDS with deep learning for stent marker detection) and treats it as a "modification of a cleared device" under a Special 510(k), it does not describe a full standalone clinical validation study for a novel AI device. The information below extracts what can be inferred or is explicitly stated, and highlights significant gaps.

A table of acceptance criteria and the reported device performance:

Feature/Metric Targeted by AI	Acceptance Criteria (Stated/Inferred)	Reported Device Performance (Stated/Inferred)
Stent Marker Detection Rate	"Improve the detection rate"	"performance was improved" (V9.5 vs V9.3)
"Fixed Display Performance"	Improved	"was improved" (V9.5 vs V9.3)

Note: These are qualitative statements of improvement, not specific quantitative acceptance criteria or performance metrics as typically seen for AI device validation.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Testing was conducted to verify the fixed display performance..." The nature of this "testing" is unclear in terms of data samples.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: Not specified, but "bench testing" usually implies retrospective analysis of existing data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Method of Ground Truth Establishment: Unclear. For "stent marker detection," ground truth would typically involve manual annotation by expert radiologists or cardiologists. This is not described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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 mentioned or implied. The focus is on the performance of the software modification itself, not on human-in-the-loop performance.
- Effect Size: Not applicable as no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The description "To improve the detection rate of the stent marker" and "Testing was conducted to verify the fixed display performance was improved" suggests that some form of standalone evaluation of the algorithm's output was done. However, specific metrics (e.g., sensitivity, specificity, F1-score for detection) are not provided. The term "fixed display performance" might refer to the accuracy of the algorithm's output as displayed.
The type of ground truth used:
- Type of Ground Truth: Not specified. For "stent marker detection," it would typically be expert annotation of stent markers on imaging data.
The sample size for the training set:
- Training Set Sample Size: Not specified. The document refers to "deep learning" but provides no details on its training.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not specified.

Summary of Gaps:

The document is a regulatory submission focused on demonstrating substantial equivalence for a minor software upgrade. It does not provide the level of detail typically found in a clinical study report for a new or significantly modified AI/ML-based medical device. Specifically, for the deep learning component, there is a lack of quantitative acceptance criteria, specific performance metrics, detailed information on test and training datasets (size, provenance), and the methodology for establishing ground truth and expert involvement. The "testing" mentioned appears to be more focused on system-level performance verification ("fixed display performance") rather than a rigorous diagnostic performance study of the AI algorithm.

Summary

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September 12, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Canon Medical Systems Corporation % Orlando Tadeo Senior Manager, Regulatory Affairs Canon Medical Systems USA, INC. 2441 Michelle Drive TUSTIN CA 92780

Re: K232526

Trade/Device Name: XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: August 18, 2023 Received: August 21, 2023

Dear Orlando 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232526

Device Name

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Made For life

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

CLASSIFICATION and DEVICE NAME 1.

Classification Name	Image-intensified fluoroscopic x-ray system
Product Code	OWB, JAA
Regulation Number	21 CFR 892.1650
Regulatory Class	Class II
Trade Proprietary Name	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

2. SUBMITTER'S NAME

Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

3. OFFICIAL CORRESPONDENT

Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance

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

Contact Person

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 483-1551 Fax: (714) 730-1310 otadeo@us.medical.canon

5. MANUFACTURING SITE

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

6. ESTABLISHMENT REGISTRATION 9614698

7. DATE PREPARED

August 18, 2023

Official Correspondent/U.S. Agent

Paul Biggins Sr. Director, Regulatory Affairs Canon Medical Systems USA 2441 Michelle Drive, Tustin, CA 92780 Phone: (714) 669-7808 Fax: (714) 730-1310 pbiggins@us.medical.canon

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8. TRADE NAME(S)

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

9. DEVICE NAME

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

1. CLASSIFICATION PANEL
  Radiology

11. DEVICE CLASSIFICATION

Class II (per 21 CFR 892.1650)

12. PRODUCT CODE / DESCRIPTION

Product Code: OWB – Interventional Fluoroscopic X-Ray System

13. PERFORMANCE STANDARD

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

14. PREDICATE DEVICE

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 (K220342)

Trade Proprietary Name	XIDF-AWS801, Angio Workstation (AlphenixWorkstation), V9.3
Marketed by	Canon Medical Systems USA, Inc.
510(k) Number	K220342
Clearance Date	September 27, 2022
Classification Name	Image-intensifiedfluoroscopic x-ray system
Product Code	OWB, JAA
Regulation Number	21 CFR 892.1650
Regulatory Class	Class II

TABLE 1: Predicate Device

15. REASON FOR SUBMISSION

Modification of a cleared device

16. SUBMISSION TYPE

Special 510(k)

17. DEVICE DESCRIPTION

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18. INDICATIONS FOR USE

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

19. SUMMARY OF CHANGE(S)

This submission is to report the following items have been changed:

Summary of Software Changes:

. Dynamic Device Stabilizer (DDS) software with deep learning is changed to improve the detection rate of the stent marker.
- *Note: This item is the target of this submission.

Summary of other software changes since K220342:

Software in the Angio Workstation was changed from V9.3 to V9.5 via Internal . Documentation
- o Electronic licenses for TAVR and CAAS
- o Support of CT DICOM
- o Support of View from foot
- o DTS patient model selection improvement
- o 3D roadmap improvement
- Serviceability improvement (Smart Update)

20. 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. 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

IEC60601-1-2:2014 + A1:2020 ●
. IEC62304:2006 + A1:2015
IEC 62366-1:2015 + A1:2020
IEC 81001-5-1:2021
IEC 62368-1:2014
ISO 14971:2007

21. TESTING

Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met. Testing was conducted to verify the fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm for Dynamic Device Stabilizer (DDS) in XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5.

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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.

A Basic Documentation Level was determined, per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, 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.

22. SUBSTANTIAL EQUIVALENCE

The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is substantially equivalent to the XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3, which received premarket clearance under K220342, marketed by Canon Medical Systems. XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5, includes modifications to the cleared device consisting of software changes from V9.3 to V9.5.

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 uses of the device.

23. CONCLUSION

The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5, performs in a manner similar to and is intended for the same use as the predicate device, as indicated in product the labeling. The modifications incorporated do not change the indications for use or the intended use of the device. 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 device. It is the contention of Canon Medical Systems Corporation 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.