The XEPHILIO MC-1100 mobile fluoroscopy system is designed to provide fluoroscopic and spot-film radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Device Description

The XEPHILIO MC-1100 mobile fluoroscopy system consists of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and a flat panel detector [Canon CSX-10]. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Mainframe can be used to acquire both still and moving images. The Workstation is a mobile platform that supports image display monitors and image processing. Interfaces are provided for optional peripherals such as recording and printing devices.

AI/ML Overview

The provided document, K121303, a 510(k) summary for the XEPHILIO MC-1100 mobile fluoroscopy system, primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, non-clinical test data, and compliance with safety standards. It does not contain detailed information about specific acceptance criteria, a study proving those criteria, or the specific performance metrics typically associated with AI/algorithm-based medical devices.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, expert involvement, and AI performance metrics cannot be directly extracted from this document.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific quantitative acceptance criteria and their corresponding reported device performance values in a comparative study are not detailed. The document generally states that "Tests were performed on the XEPHILIO MC-1100 which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s)." This indicates qualitative acceptance of comparable performance rather than specific numerical thresholds.

Acceptance Criteria (Implied)	Reported Device Performance
Safety	Device demonstrated to be safe.
Effectiveness	Device demonstrated to be effective.
Comparability to predicate devices	Device performs comparably to predicate devices.
Substantial Equivalence	Device is substantially equivalent to predicate devices.
Compliance with FDA Software Guidance	Documentation provided demonstrating compliance.
Compliance with U.S. Performance Standard for radiographic equipment	Testing confirmed compliance.
Compliance with relevant voluntary safety standards (IEC 60601 series)	Testing confirmed compliance.

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

The document mentions "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s)." However, it does not specify the sample size (number of images or cases) used in these comparisons for the test set, nor does it provide any information on the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not mention using experts to establish ground truth for image comparisons. The "non-clinical image comparisons" likely refer to technical image quality assessments rather than clinical interpretation.

4. Adjudication Method for the Test Set:

No information about an adjudication method is provided, as no expert review process is described for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that an MRMC comparative effectiveness study was conducted to evaluate human reader improvement with or without AI assistance. The device is a mobile C-Arm system, and the evaluation focuses on its performance against predicate hardware, not on AI-assisted diagnostic effectiveness.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe a standalone (algorithm only) performance study. The device is a hardware system, and the evaluations are about its overall safety and effectiveness as a medical imaging system.

7. Type of Ground Truth Used:

For the "non-clinical image comparisons," the "ground truth" would likely be based on technical image quality metrics and specifications, compared against the predicate devices. It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense, as this is a hardware device submission.

8. Sample Size for the Training Set:

The document does not mention or imply the existence of a "training set" in the context of an AI/algorithm. The device is a hardware imaging system, and its development and testing are described in terms of engineering validation and verification, not machine learning model training.

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

As there is no mention of a "training set" or an AI/algorithm being developed, there is no information on how ground truth for a training set would have been established.

Summary

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K121303

Image /page/0/Picture/1 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly tilted to the right.

5. 510(k) SUMMARY

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Submitter:	Canon, Inc. - Medical Equipment Group30-2 Shimomaruko, 3-chromeOhta-ku, Tokyo 146-8501 Japan
Contact Person:	Mr. Naoyasu AsakaStaff ManagerTEL: 81-3-3758-2111FAX: 81-3-5482-3960asaka.naoyasu@canon.co.jp
Date Prepared:	April 24, 2012 revised June 27, 2012
Trade Name:	XEPHILIO MC-1100
Common Name:	Mobile C-Arm
Classification Name:	OWB 892.1650 Solid State X-Ray Imager (Flat Panel/Digital Imager).OXO 892.1650 Mobile Image-Intensified Fluoroscopic X-Ray System
Predicate Devices:	K090590 MQB Veradius, PhilipsK021049 JAA/OXO OEC 9800 Plus, GE HealthcareK093688 MQB URS-50RF, Virtual Imaging (A Canon USA Company)K111824 MQB CSX-10, Canon, Inc.
Device Description:	The XEPHILIO MC-1100 mobile fluoroscopy system consists of two mobile units:a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised ofa high voltage generator, x-ray control, and a "C" shaped apparatus, which supportsan X-ray tube and a flat panel detector [Canon CSX-10].The Mainframe is designed to perform linear and rotational motions that allow theuser to position the x-ray imaging components at various angles and distances withrespect to the patient. The Mainframe can be used to acquire both still and movingimages.The Workstation is a mobile platform that supports image display monitors andimage processing. Interfaces are provided for optional peripherals such as recordingand printing devices.
Statement ofIntended Use:	The XEPHILIO MC-1100 mobile fluoroscopy system is designed to providefluoroscopic and spot-film radiographic images of the patient during diagnostic,surgical and interventional procedures. Examples of clinical application mayinclude cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular,cardiac, critical care and emergency room procedures. The system may be used forother imaging applications at the physician's discretion.
Summary ofTechnologicalCharacteristics:	Comparisons with the predicate devices show the technological characteristics ofthe XEPHILIO MC-1100 are substantially equivalent to the predicate devices.

.....

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Canon

5. 510(k) SUMMARY (continued)

Summary of Non-Clinical / . Test Data:

Conclusion:

Tests were performed on the XEPHILIO MC-1100 which demonstrated that the device is safe and effective, performs comparably to the predicate device(s), and is substantially equivalent to the predicate device(s). Tests included verification/validation testing to internal functional specifications (including software) and non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s). Documentation was provided demonstrating compliance of the XEPHILIO MC-1100 to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.

Testing confirmed that the XEPHILIO MC-1100 complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-1-4, 60601-2-7, 60601-2-28; 60601-2-32, and 60601-2-43.

Together, these verification/validation activities successfully demonstrated that the XEPHILIO MC-1100 correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device(s). Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the XEPHILIO MC-1100 device.

Canon, Inc. - Medical Equipment Group considers the Mobile C-Arm XEPHILIO MC-1100 to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUL 26 2012

Canon, Inc. - Medical Equipment Group % Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080

Re: K121303

Trade/Device Name: XEPHILIO MC-1100 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO and OWB Dated: April 24, 2012 Received: May 1, 2012

Dear Ms. Rutherford:

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 10 mmerce 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r reaso or a now a 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing pactice medical device-related adverse of really (21 cr r (QS) regulation (21 CFR Part 820). This letter requirences as bet for in are quandy - device as described in your Section 510(k) premarket will anow you to oogin mailioning your antial equivalence of your device to a legally marketed nothication. The I D71 midnig of succiantian vour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific at riot for your con Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Theo, promotions at 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/ReportalProblem/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 I ou may 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number:

Device Name: XEPHILIO MC-1100

Indications for Use:

Prescription Use · X (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reciological Device other of In ફાઉદ્ય

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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.