CANON DIGITAL RADIOGRAPHY CXDI-40G provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Device Description

The Canon digital radiography CXDI-40G is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

AI/ML Overview

The provided text is a 510(k) Summary for the Canon Digital Radiography CXDI-40G. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about a study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy study (e.g., clinical trials, performance benchmarks against specific metrics).

Instead, the submission focuses on substantial equivalence to previously cleared predicate devices (CXDI-11 and CXDI-22). The "proof" that the CXDI-40G meets acceptance criteria is implicitly based on its technical characteristics being similar to or the same as the predicate devices, which were already deemed safe and effective.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state acceptance criteria in terms of performance thresholds for a new study. Instead, it relies on the technical specifications and performance of the predicate devices as the de facto "acceptance criteria." The new device is presented as having "Same" or comparable performance characteristics to the cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Item / Acceptance Criteria (from Predicate Devices)	Reported CXDI-40G Performance
Intended Use: Provide diagnostic images for general radiography	Same
Energy Uses: Receives x-radiation generated by external diagnostic x-ray generator	Same
X-ray Absorber: Fluorescent screen (Gd2O2S:TB3+)	Same
Materials - Visible emission peak: 545nm	(Not explicitly stated for CXDI-40G, but implied as "Same" if the absorber is the same)
Sensing: Amorphous Silicon W/TFT Array, Detection peak: 540-620nm	Same
Anatomical Sites: General radiography	Same
Target Population: General population	Same
Physical Safety: Minimize exposure to x-radiation	Same
Compliance with Standard: Complies with IEC 601-1-2	Same
Biocompatibility: N/A (for predicate devices)	N/A
Performance (Image processing): After digital processing (optimize the gray-scale)	Same
Labeling: Approved 510(K) (for predicate devices)	Proposed Device (seeking 510(K) approval)
Pixel: 2688 × 2688 pixels (7,200,000 pixels)	Same
Image size: 43cm x 43cm	Same
Pixel pitch: 160 μm	Same
MTF: MTF@2lp/mm 42%	Same
Dynamic Range: Approximately 4 digit (linear A/D: 14bit, output data: 12bit)	Same
Grid Type: Moving grid (CXDI-11), Removable moving grid (CXDI-22)	Stationary grid (removable) (Difference noted but considered substantially equivalent)
Software Version: (V4.1 for predicate devices)	V5.0 (main changes due to CXDI-40G sensor control and GUI, considered substantially equivalent)

Study Details (Based on Substantial Equivalence Claim)

The document does not describe an independent study to "prove the device meets acceptance criteria" in a typical clinical performance study sense. Instead, the "study" is implicitly the comparison of the CXDI-40G's specifications against those of its predicate devices.

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

Not Applicable (N/A): No specific test set or clinical study data is presented. The submission relies on a descriptive comparison to predicate devices, not a new performance study with a test set of images or patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A: No test set with ground truth established by experts is described.

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

N/A: No test set or adjudication process is described.

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

N/A: No MRMC study was conducted or reported. This device is an imaging capture system, not an AI-assisted diagnostic tool.

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

N/A: This submission is for a digital radiography capture device, not a standalone AI algorithm. Its performance is assessed through technical specifications consistent with existing radiography systems.

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

N/A: No explicit ground truth data is used in this submission, as it focuses on substantial equivalence based on technical specifications and intended use. The "ground truth" for the predicate devices' performance would have been established during their respective clearance processes.

8. The sample size for the training set

N/A: This is not an AI/machine learning device submission; therefore, there is no concept of a "training set."

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

N/A: No training set is involved.

Conclusion from the Document:

The Canon Digital Radiography CXDI-40G is deemed substantially equivalent to its predicate devices (CXDI-11 and CXDI-22) based on a detailed comparison of their technical characteristics (image size, pixel pitch, number of pixels, imaging principle, materials, intended use, etc.), physical characteristics, and software. The primary differences noted relate to mechanical structure, compatibility with different stands/tables, and the type of grid used, which are presented as not raising new questions of safety or effectiveness. The software update (V5.0) is also discussed, highlighting that main changes are related to controlling the CXDI-40G sensor and GUI updates, and is compared to a previously cleared version (V4.1). The FDA's letter concurs with the substantial equivalence finding based on the information provided.

Summary

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510(k) Summary

Prepared:

August 8, 2002

K023750

Submitter:

Company Name: Canon USA, Inc. (U.S. agent/official correspondent for Canon Inc.) Company Address: One Canon Plaza

Contact Person: Phone Number: Fax Number:

Lake Success, NY 11042 Ms. Sheila Driscoll (516) 328-5602 (216) 328-2169

Proposed Device:

Reason For 510(k):	New Model
Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CXDI-40G
Classification Name:	MQB, Solid State X-ray Imager
FDA 510(k) #:	To be assigned

Predicate Device:

Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CXDI-11/CXDI-22
Classification Name:	90MQB, Solid State X-ray Image-
FDA 510(k) #:	K981556/K992547

Description Of Device:

· The CXDI-40G operates in conjunction with an upright stand, table, and universal stand while the CXDI-11 operates only in conjunction with an upright stand, and the CXDI-22 only operates in conjunction with a table.

Intended Use:

Canon digital radiography CXDI-40G provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Technical Characteristics:

Please refer to the attached COMPARISON CHART.(Table 10)

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Descriptive Comparison

The predicate device is the Canon digital radiography CXDI-11 cleared under Document Number K981556 on November 4, 1998 and CXDI-22 cleared under Document Number K992547 on October 13, 1999.

The CXDI-40G's technical specifications (including image size, pixel pitch, number of pixels), imaging principle, physical characteristics and intended use are the same as those of CXDI-11 and CXDI-22. However, the differences in the design are as follows:

· The mechanical structure and physical appearance of the CXDI-40G are different than the CXDI-11 and CXDI-22. Please refer to the attached CXDI-40G comparison table provided in this section. Additional information can also be found in the CXDI-40G Operation Manual provided in this submission.
· The CXDI-40G can be used with upright stand, table, and universal stand by using the installation unit for each application, while the CXDI-11 is used with upright stand only and the CXDI-22 is only used with a table.
· A removable, fixed grid is used for the CXDI-40G, while an implemented, moving grid is used for the CXDI-11 and a removable moving grid is used for the CXDI-22. Both types of grids are used for eliminating the dispersed X-ray in exposures that use films. (See attached Table 4.2)

Regarding the software:

The system software for controlling CXDI-40G is released as V5.0. 8
l V5.0 includes some changes from V4.1.
· The main changes of the V5.0 are the addition of the control of CXDI-40G sensor and some change of GUI.
· V4. I was first introduced and cleared under K003689 and is currently used in Canon models CXDI-11, CXDI-22, and CXDI-31.
· The comparison between V5.0 and V4.1 is described in the Software Information for model CXDI-40G section.

Based on the information in this submission, similarity to the predicate devices (Canon digital radiography CXDI-11 and CXDI-22), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-40G described in this submission is substantially equivalent to the predicate devices

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comparisonofbleC-
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	Item	CXDI-11	CXDI-22	CXDI-40G
	FDA 510(k)#	K981556	K992547	Proposed Device
	Intended Use	Provide diagnostic images for general	Provide diagnostic images for general	Provide diagnostic images for general
	Design	radiography with upright system,Digital acquisition,electronic processing	radiography with table system	radiography
	Energy Uses	Receives x-radiation generated by external diagnostic x-ray generator	Same	Same
	X-ray Absorber	Fluorescent screen (Gd2O2S:TB3+)	Same	Same
	Materials	Visible emission peak: 545nm
Item	CXDI-11	CXDI-22	CXDI-40G
Sensing	Amorphous Silicon W/TFT Array	Same	Amorphous Silicon W/TFT Array
	Detection peak: 540- 620nm	Same	Detection peak: 540- 620nm
Anatomical Sites	General radiography	Same	Same
Target Population	General population	Same	Same
Physical Safety	Minimize exposure to x-radiation	Same	Same
Compliance with Standard	Complies with IEC 601-1-2	Same	Same
Biocompatibility	N/A	N/A	N/A
Performance	After digital processing ( optimize the	Same	Same
	gray-scale)	Same	Same
Labeling	Approved 510(K)	Approved 510(K)	Approved 510(K)
Pixel	2688 × 2688 pixels	Same	Same
Item	CXDI-11	CXDI-22	CXDI-40G
	(7,200,000 pixels)	Same	Same
Image size	43cm x 43cm	Same	Same
Pixel pitch	160 μ m	Same	Same
MTF	MTF@2lp/mm 42%	Same	Same
Dynamic Range	Dynamic range:approximately 4 digit( linear A/D : 14bit)( output data : 12bit)	Same	Same
Grid	Moving grid	Moving grid( removable )	Stationary grid( removable )
Sensor Unit Dimension	552 x 598 x 231mm	604 x 645 x 73.50r69mm	550x 550 x 68mm
Item	CXDI-11	CXDI-22	CXDI-40G
Power Supply Dimension	580 x 489 x 275mm	390 x 160 x 110mm	390 x 160 x 110mm
Control PC Dimension	483.5 x 594 x 300mm	453 x 594 x 300mm	453 x 594 x 300mm
Operation Unit Dimension	298 x 209.5 x 130mm	Same	398 x 395 x 150
Card Reader Dimension	50 x 180 x 39mm	Same	Same
Stand Dimension	900 x 475 x 2100mm	N/A	(900 x 480 x 2000) *
Table Dimension	N/A	(2025 x 820 x 890) *	(2025 x 820 x 890) *

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*: These dimensions are anylicable for the stand and the table made by canon inc. It is possible to use another stands and tables.

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Image /page/6/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and body.

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

Canon. Inc. % Ms. Pamela K. Gwynn Engineering Team Leader Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

AUG 23 2013

Re: K023750

Trade/Device Name: Canon Digital Radiography Model CXDI-40G Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 7, 2002 Received: November 8, 2002

Dear Ms. Gwynn:

This letter corrects our substantially equivalent letter of November 22 2002.

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.

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 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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

Janine M. Mdrri 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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Section 3: Statement

Indications Statement

Page l of I

510(K)Number(if known): KU23

Device Name:

Indications for Use:

CANON DIGITAL RADIOGRAPHY CXDI-40G provides digital image capture for conventional film/screen radiographic examinations.

The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

David h. Lippman

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 3-1

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.