CANON DIGITAL RADIOGRAPHY CXDI-50G 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-50G 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

Here's an analysis of the provided text regarding the Canon CXDI-50G device, focusing on acceptance criteria and study details.

Based on the provided text, the Canon CXDI-50G is a digital radiography device intended to replace conventional film/screen radiographic systems. The submission is a 510(k) premarket notification to establish substantial equivalence to predicate devices (Canon CXDI-31 and CXDI-40G).

Critically, the provided document DOES NOT contain a study with specific acceptance criteria and performance metrics for the CXDI-50G itself, nor does it detail a standalone clinical performance study or a multi-reader multi-case (MRMC) comparative effectiveness study.

The submission primarily focuses on demonstrating substantial equivalence based on:

Technical Specifications: Stating that the technical specifications, imaging principle, physical characteristics, and intended use are "the same as those of the CXDI-40G including pixel pitch," with modifications primarily in physical appearance, mechanical structure, and sensor size (from 43x43cm to 35x43cm).
Software Changes: Highlighting that the control software V6.0 for CXDI-50G includes changes from V5.0 (used in CXDI-40G) to add control for the CXDI-50G sensor and some GUI changes.
Design Control Activities: General reference to "results of our design control activities" to support equivalence.

Since there is no explicit performance study detailed for the CXDI-50G against defined acceptance criteria, I cannot fill in most of the requested information. However, I can infer what the "acceptance criteria" and "reported device performance" are being judged against: substantial equivalence to the predicate devices.

Summary of Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Technical Equivalence:	"The CXDI-50G's technical specifications, imaging principle, physical characteristics and intended use are the same as those of the CXDI-40G including pixel pitch."
- Imaging Principle	Same as CXDI-40G
- Pixel Pitch	Same as CXDI-40G
- Intended Use	"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." (Same as predicate)
Mechanical/Physical Equivalence:	Difference noted in mechanical structure, physical appearance, and imaging area (35x43cm vs 43x43cm for CXDI-40G). However, deemed not to affect substantial equivalence.
Software Equivalence:	V6.0 software introduced for CXDI-50G, building upon V5.0 (used in CXDI-40G), with main changes for CXDI-50G sensor control and GUI. Deemed not to affect substantial equivalence.

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

Not explicitly stated in the provided text. The document relies on similarity to predicate devices rather than a new standalone test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No specific independent expert review for a test set is described. The assessment is based on the manufacturer's technical comparison to predicate devices, reviewed by the FDA.

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

Not applicable. No specific adjudication method for a test set 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

No, an MRMC comparative effectiveness study was not done or reported. This device primarily focuses on converting conventional X-ray images to digital, not on AI-assisted interpretation.

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

No, a standalone performance study against specific clinical criteria was not explicitly detailed or reported in this document. The submission is for substantial equivalence to existing devices that are already cleared for standalone use in digital radiography.

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

Not explicitly stated. The "ground truth" for the substantial equivalence claim is essentially the established performance and safety of the predicate devices (CXDI-31 and CXDI-40G).

8. The sample size for the training set

Not applicable/Not stated. This document describes a hardware device (digital X-ray imager) and its controlling software, not a machine learning algorithm that would require a "training set" in the conventional sense.

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

Not applicable/Not stated. See point 8.

In conclusion: The provided 510(k) submission for the Canon CXDI-50G is a declaration of substantial equivalence to previously cleared predicate devices (CXDI-31 and CXDI-40G). It does not present a de novo clinical study with specific acceptance criteria, a test set, expert review, or detailed performance metrics for the CXDI-50G as a new device. The "acceptance criteria" are implicitly met by demonstrating that the device is technically and functionally equivalent to already cleared devices, suggesting that its performance would be similar and thus acceptable.

Summary

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MAY 21 2003

Prepared:

March 26, 2003

Submitter:

Company Name: Canon USA, Inc. (U.S. agent for Canon Inc.) Company Address: One Canon Plaza Lake Success, NY 11042 Contact Person: Ms. Sheila Driscoll Phone Number: (516) 328-5602

Proposed Device:

Fax Number:

Reason For 510(k):	New Model
Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CXDI-50G✓ 6. 0
Classification Name:	MQB, Solid State X-ray Imager
FDA 510(k) #:	To be assigned

(516) 328-5169

Predicate Device:

Manufacturer:	C
Trade Name:	C
Model Name:	C
Classification Name:	9
FDA 510(k) #:	F

anon Inc. 'anon XDI-31/CXDI-40G 0MQB, Solid State X-ray Imager 003689/K023750

Description Of Device:

The Canon digital radiography CXDI-50G is different from CXDI-31 and CXDI-40G in the following respect:

· The CXDI-50G is a portable unit as same as the CXDI-31. It is positioned on a table or installed in a holder during its operation as a film cassette is while the CXDI-40G operates in conjunction with an upright stand, table, and universal stand.
The principle of the CXDI-50G is the same as the CXDI-40G, with some modifications of its housing in size and shape. The sensor of the CXDI-50G has the same characteristics as the CXDI-40G and the imaging area is changed from 43x43cm to 35x43cm.

The CXDI-50G itself is a component without a control PC. Using a general purpose computer with appropriate specifications and the designated system software installed in it, as a control PC, the CXDI-50G achieves performance stated herein (such as image capturing, DICOM

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Intended Use:

Canon digital radiography CXDI-50G 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.

Descriptive Comparison

The predicate devices are the Canon digital radiography CXDI-40G cleared under Document Number K023750 on November 22, 2002 and CXD1-31 cleared under Document Number K003689 on January 2, 2002.

The CXDI-50G's technical specifications, imaging principle, physical characteristics and intended use are the same as those of the CXDI-40G including pixel pitch. However, the differences in the design are as follows:

· The mechanical structure and physical appearance of the CXDI-50G are different than the CXDI-31 and the CXDI-40G. Additional information can also be found in the CXDI-50G User's Manual provided in this submission.
· A removable, fixed grid is used for the CXDI-50G the same as the CXDI-31 and the CXDI-40G. The both grids for the CXDI-50G and the CXDI-31 are installed outside the sensor housing, while the gird for the CXDI-40G is instated inside the sensor housing. Both types of grids are used for eliminating the scatter X ray in exposures that use films.

Regarding the software:

The system software for controlling CXDI-50G is released as V6.0. •
. V6.0 includes some changes from V5.0.
· The main changes of the V6.0 are the addition of the control of CXDI-50G sensor and some change of GUI.
· V5.0 was first introduced and cleared under K023750 and is currently used in Canon models the CXDI-40G.

Based on the information in this submission, similarity to the predicate devices (the Canon digital radiography CXDI-31 and the CXDI-40G), and the results of our design control activities, it is our opinion that the Canon digital radiography CXDI-50G described in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Canon, Inc. % Mr. Joseph Murnane Senior Staff Engineer Underwriters Laboratories, Inc. Melville Division 1285 Walt Whitman Road MELVILLE NY 11747-3081

Re: K031447

Trade/Device Name: Canon, Digital Radiography Model CXDI-50G Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 MOB Dated: May 7, 2003 Received: May 7, 2003

Dear Mr. Murnane:

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 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); 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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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3: Statement

Indications Statement

510(K)Number(if known):	K 031447
Device Name:	CANON DIGITAL RADIOGRAPHY CXDI-50G-V6.

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Indications for Use:

CANON DIGITAL RADIOGRAPHY CXDI-50G 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(Per 21 CFR 801.109)	✓
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Over-The-Counter Use
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(Optional Format 1-2-96)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031447

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.