As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

Device Description

The subject of this Special 510(k) submission is a change to the CXDI Control Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Enhanced Feature Software Pack for CXDI Series, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and device performance metrics. However, the core change in the proposed device is the "One Shot Long Length Imaging" feature, which involves automatic stitching of images from multiple detectors with manual adjustment capabilities. The performance is largely implied by the claim of substantial equivalence and successful mitigation of risks.

Acceptance Criteria (Implied)	Reported Device Performance
Image Quality / Stitching Accuracy for One Shot Long Length	The "One Shot Long Length" feature allows obtaining images across multiple detectors, automatically stitched together, with the ability to make manual adjustments after the automatic stitching. It enables capturing images up to 120cm in length in one exposure. The text implies that the performance for this feature is adequate, and substantially equivalent to the predicate device for its intended use, as no specific performance deficiencies are noted. The study would have demonstrated that the automatically stitched images are clinically acceptable and that the manual adjustment feature provides sufficient control for fine-tuning.
Safety and Effectiveness	The hardware within the Canon Digital Radiography CXDI Series Detectors has not been modified, and the detectors retain the same performance, biocompatibility, effectiveness, and safety as the predicate device. A FMEA methodology was used to analyze risks and hazardous impacts of the device modification, and risk control and protective measures were reviewed and implemented. "The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted." The device complies with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-32), and FCC and ICES standards for wireless detectors. This indicates that the device's performance, post-modification, continues to meet established safety and effectiveness standards, especially given that the core imaging hardware remains unchanged.
Maintenance of Indication for Use	The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s). This is explicitly stated, suggesting the new feature does not alter the fundamental clinical applications for which the device is intended.

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

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission refers to a "Special 510(k) Submission" for a software change, and typically such submissions might rely on internal validation and verification testing demonstrating that the new feature does not adversely affect the already cleared device's performance.

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

This information is not provided in the document. The submission focuses on the technical aspects of the software modification and its substantial equivalence. Clinical studies with expert-adjudicated ground truth are not explicitly mentioned in this summary.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The "Enhanced Feature Software Pack" introduces an "One Shot Long Length Imaging" feature that automatically stitches images, but it's not described as an AI-driven diagnostic aid that would typically involve an MRMC study for assessing reader performance. It's more of an image acquisition and processing enhancement.

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

The document does not explicitly state that a standalone performance study was done for the "One Shot Long Length Imaging" algorithm. However, given that it's an automated stitching process, internal verification and validation testing would have been conducted to ensure the accuracy and quality of the stitched images generated by the algorithm. This would be a form of standalone testing, but specific metrics and methodology are not detailed here.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for any testing. For an image stitching feature, ground truth would likely involve measurements of anatomical alignment and continuity as determined by expert review or comparison to reference images, but this is not explicitly stated.

8. The Sample Size for the Training Set

This information is not provided in the document. The device primarily involves an automated image stitching algorithm, rather than a machine learning model that typically requires a large training set in the conventional sense.

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

This information is not provided in the document. As mentioned above, it's unclear if a traditional "training set" with ground truth, as used for machine learning, was employed in the development of this image stitching feature.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Canon, Inc. % Ms. Katie Reneson Regulatory Specialist Ken Block Consulting 800 East Campbell Road. Suite 202 RICHARDSON TX 75081

March 13, 2019

Re: K190368

Trade/Device Name: Enhanced Feature Software Pack for CXDI Series Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 14, 2019 Received: February 15, 2019

Dear Ms. Reneson:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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

(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

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

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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190368

Device Name

Enhanced Feature Software Pack for CXDI Series

Indications for Use (Describe)

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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5. Special 510(k) SUMMARY

Submitter:	Canon, Inc.30-2 Shimomaruko, 3-chromeOhta-ku, Tokyo 146-8501 Japan
Contact Person:	Mr. Tatsuya YamazakiGeneral ManagerTEL: 81-3-3758-2111;FAX: 81-3-5482-3960yamazaki.tatsuya@mail.canon
Date Prepared:	February 14, 2019
Submission Type:	Special 510(k) Submission
Trade Name:	Enhanced Feature Software Pack for CXDI Series
Common Name:	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulatory Number:	21 CFR 892.1680
Classification Name:	Stationary X-ray system
Product Code:	MQB
Primary Predicate #1:	MQB K153312 Scatter Correction for CXDI Series
Predicate #2:	MQB Canon DIGITAL RADIOGRAPHY CXDI Series Detectors510(k) # ModelsK170332 CXDI-710C WirelessK171270 CXDI-410C Wireless

The subject of this Special 510(k) submission is a change to the CXDI Control Device Description: Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.

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Indications for Use Statement

The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).

As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

Summary of Technological Characteristics:

Comparisons with the predicate devices show the characteristics of the proposed addition of the One Shot Long Length feature to the Enhanced Feature Software Pack for CXDI Series to be substantially equivalent to the predicate device(s). The One Shot Long Length feature of the Enhanced Feature Software Pack for CXDI Series can only be used with compatible Canon CXDI detectors CXDI-710C Wireless, CXDI-410C Wireless.

Trade Name	Proposed DeviceEnhanced Feature Software Packfor CXDI Series	PredicateControl Software V2.14Scatter Correction
510(k)Submitter[Number]	Canon, Inc.[K190368]	Canon, Inc.[K153312]	IDENTICAL
Indicationfor Use	As a part of the CXDI seriesradiography system, the CXDIControl Software when usedwith a compatible CXDIdetector is intended to providedigital image capture,processing, and display forconventional film/screenradiographic examinations. Thisdevice is intended to replaceradiographic film/screen systemsin all general purpose diagnosticprocedures including specialistareas like intensive care, trauma,and pediatric work. This deviceis not intended for fluoroscopic.angiographic, or mammographyapplications.	As a part of the CXDI seriesradiography system, the CXDIControl Software when usedwith a compatible CXDIdetector is intended to providedigital image capture,processing, and display forconventional film/screenradiographic examinations.This device is intended toreplace radiographicfilm/screen systems in allgeneral purpose diagnosticprocedures including specialistareas like intensive care,trauma, and pediatric work.This device is not intended forfluoroscopic, angiographic, ormammography applications.	IDENTICAL
ScatterCorrection	An image can be created (withhigh contrasts) by using softwarealgorithm, in clinical field,without a grid	An image can be created (withhigh contrasts) by usingsoftware algorithm, in clinicalfield, without a grid	IDENTICAL
One ShotLong LengthImaging	One exposure to obtain imagesacross multiple detectors,automatically stitched togetherwith ability to make manualadjustments after the automaticstitching.	N/A	MODIFIED
Software/Version	CXDI Control Software V2.17	CXDI Control Software V2.14(highest version clearedpreviously)	MODIFIED

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Trade Name	Proposed DeviceCanon DIGITALRADIOGRAPHY CXDI SeriesDetectors containing EnhancedFeature Software Pack for CXDISeries	Predicate DeviceCanon DIGITALRADIOGRAPHY CXDISeries Detectors
510(k)Submitter[Number]	Canon, Inc.[K190368]	Canon, Inc.[K170332, K171270]	IDENTICAL
Indicationfor Use	The DIGITALRADIOGRAPHY CXDI SeriesDetectors provides digital imagecapture for conventionalfilm/screen radiographicexaminations. This device isintended to capture for displayradiographic images of humananatomy, and to replaceradiographic film/screen systemsin all general purpose diagnosticprocedures. This device is notintended for mammographyapplications.	The DIGITALRADIOGRAPHY CXDISeries Detectors providesdigital image capture forconventional film/screenradiographic examinations.This device is intended tocapture for displayradiographic images of humananatomy, and to replaceradiographic film/screensystems in all general purposediagnostic procedures. Thisdevice is not intended formammography applications.	IDENTICAL
ScatterCorrection	An image can be created (withhigh contrasts) by using softwarealgorithm, in clinical field,without a grid	An image can be created (withhigh contrasts) by usingsoftware algorithm, in clinicalfield, without a grid	IDENTICAL
One ShotLong LengthImaging	One exposure to obtain imagesacross multiple detectors,automatically stitched togetherwith ability to make manualadjustments after the automaticstitching.	N/A	MODIFIED
Firmware/Version	04-02-0c-00	04-02-0b-00	MODIFIED

Performance: The hardware within the Canon Digital Radiography CXDI Series Detectors has not been modified, the detectors have the same performance, biocompatibility, effectiveness, and safety and is substantially equivalent to the predicate device. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted. As reported in prior submissions to FDA, the compatible detectors comply 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, and 60601-2-32. The wireless detectors also comply with the FCC test standard for SAR, specifically 47CFR 2.1093 and for EMI test regulations FCC Part 15 Subpart B:2012 Class A and ICES-003 Issue 5:2012 Class A. Canon, Inc. considers the Enhanced Feature Software Pack for CXDI Series to be Conclusion: 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.

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.