The flat panel detector CSX-30 is designed to provide fluoroscopic and spot radiographic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include angiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical-care and emergency room procedures or other imaging applications at the physician's discretion. The device is intended to replace spot-film device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

Device Description

The CSX-30 is a digital radiography flat panel detector that can take fluoroscopic and spot radiographic images of any part of the body. It directly converts the X-ray images captured by the sensor into high-resolution digital images. The instrument is a component of an x-ray system and as such cannot be used outside of such a system. This unit converts the X-rays into digital signals. Not intended for mammography applications.

AI/ML Overview

The provided text describes a 510(k) summary for a flat panel detector (CSX-30), which is a component of an X-ray system. The study described focuses on demonstrating substantial equivalence to a predicate device (CSX-10) rather than proving "device meets acceptance criteria" in the context of clinical performance or diagnostic accuracy of an AI algorithm.

Therefore, many of the requested criteria for AI/diagnostic studies, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, or specific ground truth methodologies for clinical conditions, are not applicable or detailed in this document because the device is a hardware component (a flat panel detector), not an AI-driven diagnostic system.

The "acceptance criteria" here relate to engineering specifications, safety standards, and performance characteristics compared to a predicate device.

However, I can extract the information that is present and note what is not applicable.

Here's the summary based on the provided document:

Acceptance Criteria and Device Performance Study for CSX-30 Flat Panel Detector

The study aimed to demonstrate substantial equivalence of the new device (CSX-30 Flat Panel Detector) to a legally marketed predicate device (CSX-10 Flat Panel Detector). The "acceptance criteria" are implied by the comparison to the predicate device and compliance with relevant standards.

1. Table of Acceptance Criteria (Implied by Comparison) and Reported Device Performance

Parameter/Acceptance Criteria (Implied)	New Device: CSX-30 (K162909)	Predicate Device: CSX-10 (K111824)	Performance Status vs. Predicate
Application	Fluoroscopy and Spot Radiology	Fluoroscopy and Spot Radiology	Identical
Technology	Flat panel detector: Scintillator and CSX sensing unit	Flat panel detector: Scintillator and CSX sensing unit	Identical
Scintillator	CsI(TI) [Cesium Iodide doped with Thallium]	CsI(TI) [Cesium Iodide doped with Thallium]	Identical
Pixel Pitch	160 x 160 μm	160 x 160 μm	Identical
Pixels	2,496 x 1,856 (approx 4.6 million)	1,792 x 1,632 (approx 2.9 million)	Modified (Increased)
Image Size	399 x 297 mm	287 x 261 mm	Modified (Increased)
Overall Dimensions	470 x 363 x 82.5 mm	360 x 346 x 65.5 mm	Modified (Increased)
Weight	19.0 kg	6.7 kg	Modified (Increased)
Acquisition Mode (Binning mode)	Up to 60 fps (1x1)Up to 230 fps (2x2)Up to 300 fps (4x4)	Up to 30 fps (1x1)Up to 100 fps (2x2)Up to 200 fps (4x4)	Modified (Increased Performance)
A/D Conversion	16-bit	14-bit	Modified (Increased)
Safety and Performance Standards	Compliance with various IEC standards (60601-1, -1-2, -1-3, -1-9, -2-32, -2-54, 60825-2, 60825-1, 62220-1-3), FDA Guidance for Solid State X-ray Imaging Devices, and Software Contained in Medical Devices.	(Implied compliance for predicate)	Confirmed Compliance
Image Quality	Non-clinical image comparisons show equivalence to predicate.	(Predicate image quality confirmed)	Comparable/Equivalent

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

Sample Size: The document does not specify a distinct "test set" sample size in terms of number of patients or images for clinical performance evaluation, as this is a hardware device submission focusing on engineering and safety. It mentions "non-clinical image comparisons involving flat panel display images." The exact number of images or test runs for these comparisons is not specified.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be "non-clinical," focusing on device performance and safety characteristics rather than clinical trial data on specific patient populations. It is retrospective in the sense that a comparison is made to an existing predicate device's characteristics.

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

Not Applicable/Not Specified: As this is a hardware device submission focused on technical specifications and safety standards, the concept of "ground truth" derived from expert consensus on clinical diagnoses (e.g., by radiologists) is not relevant in the way it would be for an AI diagnostic device. The "truth" is established by direct measurement of device parameters and compliance with engineering standards.

4. Adjudication Method for the Test Set

Not Applicable: No clinical adjudication process is described as this is not a clinical diagnostic performance study requiring expert consensus on findings.

5. MRMC Comparative Effectiveness Study

Not Performed/Applicable: An MRMC study is typically for evaluating the impact of an AI system on human reader performance. This study is for a flat panel detector (hardware component), not an AI algorithm.

6. Standalone Performance Study (Algorithm Only)

Not Applicable: This is not an AI algorithm. The performance of the flat panel detector is assessed through its technical specifications (e.g., pixel count, frame rate, A/D conversion), compliance with safety standards, and non-clinical image quality comparisons with the predicate.

7. Type of Ground Truth Used

Engineering Specifications and Standard Compliance: The "ground truth" for this device's performance is based on its measured physical and electrical characteristics (e.g., pixel count, dimensions, weight, frame rate, A/D conversion), its ability to meet specified performance parameters (e.g., DOE, dynamic range), and its adherence to established national and international safety and performance standards (e.g., IEC 60601 series, FDA Guidance documents). Comparison of "flat panel display images" implies direct image quality assessment, often against a reference or the predicate.

8. Sample Size for the Training Set

Not Applicable: This is a hardware device, not an AI model that requires a training set.

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

Not Applicable: As there is no training set for an AI model, this question is not relevant.

In conclusion, the provided document details a 510(k) submission for a non-AI medical imaging hardware component, focusing on demonstrating substantial equivalence to a predicate device through technical specification comparisons and compliance with relevant safety and performance standards. Many of the questions posed are specifically for AI/software as a medical device (SaMD) clinical performance studies and therefore do not apply to this submission type.

Summary

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

January 27, 2017

Canon, Inc. - Medical Equipment Group % Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson TX 75080

Re: K162909

Trade/Device Name: CSX-30 Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, JAA Dated: December 27, 2016 Received: December 28, 2016

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 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.

Michael D'Hara

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

For

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K162909

Device Name CSX-30 Flat Panel Detector

Indications for Use (Describe)

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)

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."

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5. 510(k) SUMMARY

Submitter:	Canon, Inc. – Medical Equipment Group9-1, Imaikami-cho, Nakahara-kuKawasaki, Kanagawa 211-8501, Japan
Contact Person:	Mr. Shinji MoriManagerTEL: 81-3-3758-2111FAX: 81-44-739-6493shinji.mori@canon.co.jp
Date Prepared:	September 27, 2016
Proposed Device	Manufacturer: CanonTrade Name: CSX-30 Flat Panel DetectorCommon Name: Solid State X-ray ImagerClassification Name: Stationary X-ray systemProduct Code / Regulatory Standard: MQB, JAA892.1680 Stationary X-ray System
Predicate Device:	Clearance: K111824 dated April 23, 2012Manufacturer: CanonTrade Name: CSX-10 Flat Panel DetectorCommon Name: Solid State X-ray ImagerClassification Name: Stationary X-ray systemProduct Code / Regulatory Standard: MQB892.1680 Stationary X-ray System
Device Description:	The CSX-30 is a digital radiography flat panel detector that can take fluoroscopicand spot radiographic images of any part of the body. It directly converts the X-rayimages captured by the sensor into high-resolution digital images. The instrument isa component of an x-ray system and as such cannot be used outside of such asystem. This unit converts the X-rays into digital signals. Not intended formammography applications.
Indications for Use:	The flat panel detector CSX-30 is designed to provide fluoroscopic and spotradiographic images of human anatomy during diagnostic, surgical andinterventional procedures. Examples of clinical application may includeangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac,critical-care and emergency room procedures or other imaging applications at thephysician's discretion. The device is intended to replace spot-film devices. Thedevice is also intended to replace fluoroscopic images obtained through imageintensifier technology. Not intended for mammography applications.The Intended Use of the CSX-30 is the same as for the predicate device, CSX-10.
Summary ofTechnologicalCharacteristics:	Comparison with the predicate shows the technological characteristics of theCSX-30 are substantially equivalent to the predicate device. The flat panel detectorunits are functionally identical.The CSX-30 is the next model in the CSX family of detectors. The differencesbetween the CSX-30 and the predicate CSX-10 are primarily increased size andincreased performance. Increased size results in larger dimensions, larger image

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area, more pixels, and increased weight over the predicate. Performance has been increased resulting in increased DOE, dynamic range, and frame rates. These modifications have been incorporated into the CSX-30 in an effort to improve the product performance.

	New Device: CSX-30K162909	Predicate Device: CSX-10K111824
Application	Fluoroscopy and Spot Radiology	Fluoroscopy and Spot Radiology	Identical
Technology	Flat panel detector:Scintillator and CSXsensing unit	Flat panel detector:Scintillator and CSXsensing unit	Identical
Scintillator	CsI(TI)[Cesium lodide dopedwith Thallium]	CsI(TI)[Cesium lodide dopedwith Thallium]	Identical
Pixel Pitch	160 x 160 μm	160 x 160 μm	Identical
Pixels	2,496 x 1,856(approx 4.6 million)	1,792 x 1,632(approx 2.9 million)	Modified
Image Size	399 x 297 mm	287 x 261 mm	Modified
Overall Dimensions	470 x 363 x 82.5 mm(Except flexible tubes and minorprotrusions)	360 x 346 x 65.5 mm	Modified
Weight	19.0 kg	6.7 kg	Modified
Acquisition Mode(Binning mode)	Up to 60 fps (1x1)Up to 230 fps (2x2)Up to 300 fps (4x4)	Up to 30 fps (1x1)Up to 100 fps (2x2)Up to 200 fps (4x4)	Modified
A/D Conversion	16-bit	14-bit	Modified

Summary of Non-Clinical /Test Data:

Tests were performed on the device which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device.

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 devices. Documentation was provided demonstrating compliance of the CSX-30 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.

Documentation was provided demonstrating that the CSX-30 complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. The evaluations of the CSX-30 compared to the CSX-10, show the CSX-30 to be equivalent to the CSX-10.

Testing confirmed that the CSX-30 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, 60601-1-2, 60601-1-3, 60601-1-9, 60601-2-32, and 60601-2-54. Testing also confirmed compliance to relevant voluntary safety standards IEC 60825-2, IEC 60825-1, and IEC 62220-1-3.

Together, these verification/validation activities successfully demonstrated that the CSX-30 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 devices. Therefore, the verification testing conducted supports a determination of substantial equivalence for the CSX-30 device.

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Integration: The CSX-30 is a hardware only FPD for integration into x-ray systems. The CSX-30 connects to an x-ray imager control PC and does not connect directly to an x-ray generator. The Instruction Manual provides detailed instructions and information for safe and effective system integration including: system configuration; electrical, mechanical, and cooling requirements; installation conditions; interfaces (image, command and service, and power input). Integrators are expected to adhere to the instructions and other information in the published Installation Manual. Conclusion:

Canon, Inc. – Medical Equipment Group considers the CSX-30 to be substantially equivalent to the predicate device listed above. This conclusion is based on the same intended use and similar principles of operation, functional design, and established medical use for the flat panel detector.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.