CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 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

CANON X-RAY DIGITAL CAMERA CXDI-11 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 digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device is used to capture the image in electronic form. The digital data are then used to produce diagnostic hardcopy and reference-softcopy images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Canon X-Ray Digital Camera CXDI-11, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically seen. Instead, the study's goal was to demonstrate that the image quality of the Canon Digital Radiography System (CXDI-11) was substantially equivalent to conventional x-ray film. This qualitative assessment of "substantial equivalence" is the de-facto acceptance criteria.

Acceptance Criteria (Inferred from Study Goal)	Reported Device Performance (CXDI-11)
Substantial equivalence in image quality to conventional x-ray film.	Image quality consistently indicated as equivalent or of higher quality than analog film.

Additional Performance Metrics (not explicitly linked to "acceptance criteria" but included in comparison):

Metric	CXDI-11 Performance	Predicate Device (Screen-Film) Performance
MTF	MTF@2lp/mm 42%	MTF@2lp/mm 33% (Lanex 250/TMS-RA)(Kodak)
Dynamic Range	Approximately 4 digit (linear A/D: 14 bit, output data: 12 bit) - can utilize wider dynamic range to control image visualization.	Approximately 1.5 digit
Image Processing	Performs digital image processing, can optimize image visualization even after exposure.	Development of film, uses its own H character, gray-scale fixed by exposure condition.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of cases or images. The document mentions "various inpatient cases."
- Data Provenance: Not specified, but given the context of a 510(k) summary for a US market application, it's reasonable to infer that the data was likely from a US (or generally Western) clinical setting. It is a retrospective study as it involved evaluating "analog films... read twice."
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified. The document states "Qualified readers evaluated both digital and analog films."
- Qualifications of Experts: Not explicitly stated, beyond being "Qualified readers." Typically, for imaging studies, these would be radiologists, but their specific experience level is not provided.
Adjudication Method for the Test Set:
- Not explicitly stated. The study involved "Qualified readers evaluated both digital and analog films." There's no mention of multiple readers reaching a consensus or any formal adjudication process beyond individual readers' assessments. The mention of readers reading analog films twice to assess consistency suggests individual reader scoring rather than a consensus approach for the primary equivalency comparison.
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 in the context of human readers improving with AI assistance.
- This study was a comparison between a new digital radiography system (CXDI-11) and a conventional film/screen system, not an AI-assisted interpretation study. The CXDI-11 device is a capture device, not an AI interpretation tool.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, a comparison of the "standalone" performance of the imaging systems was done. The study's primary objective was to evaluate the image quality of films generated by the CXDI-11 compared to conventional film, as assessed by human readers. While human readers were involved in the assessment, the focus was on the inherent quality of the image produced by the device, not the reader's diagnostic performance with or without the device (beyond assessing image quality).
The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The "ground truth" for the comparison of image quality was based on expert subjective assessment by "qualified readers." They evaluated the images for "overall image quality, as well as for image quality with respect to specific anatomical areas." There's no mention of objective pathology or outcomes data being used to establish a 'true' diagnosis or lesion presence for the purpose of image quality assessment. The "ground truth" here is the perceived quality by experts.
The Sample Size for the Training Set:
- Not applicable / Not mentioned. The CXDI-11 is an X-ray digital camera, a hardware device for capturing images. It's not an AI algorithm that learns from a training set of data. The document describes a clinical evaluation study for image quality, not the development or training of an AI model.
How the Ground Truth for the Training Set was Established:
- Not applicable / Not mentioned. As explained above, there is no AI algorithm training set for this device.

Summary

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4 1998 NOV

510(k)Summary

1.Date Prepared:	April 1, 1998
2.Applicant's Name:	Canon USA, Inc.
	One Canon Plaza.
	Lake Success, NY 11042
	Mr. Glenn Impal/Mr. Ken Shadoff
	Phone:	(516)328-5600
	Fax.	(516)328-5169
3.Model Name:	CANON X-RAY DIGITAL CAMERA CXDI-11
	90MQB, Solid State X-ray Imaging Device
4.Predicate Model:	Radiographic Film (892.1840)
	Radiographic Intensifying Screen (892.1960)
5.Device Description:	CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture andconvert conventional projection X-ray images to digital images. A sub-sampledimage can be displayed on a preview monitor for viewing.The diagnostic image can be transmitted through a digital network for printing.The device provides digital image capture for conventional film/screenradiographic examinations.CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-raysystems in that instead of exposing a film for subsequent wet chemicalprocessing to create a hardcopy image, a device is used to capture the image inelectronic form. The digital data are then used to produce diagnostic hardcopyand reference-softcopy images.
6.Intended Use:	CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generatingradiographic Images of human anatomy. It is intended to replace radiographicfilm/screen systems in all general purpose diagnostic procedures.
7.Comparison topredicate Device	CANON X-RAY DIGITAL CAMERA CXDI-11 device uses an electronic readoutof an image while conventional film/screen systems require chemical processingto produce image.CANON X-RAY DIGITAL CAMERA CXDI-11 device produces a digital imagewhile conventional film/screen systems produce an analog image.

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510(K) Summary (continued)

Clinical Evaluation of Canon Digital Radiography System, Model CXDI-11

A study was conducted to evaluate whether image quality of film obtained from the Canon Digital Radiography System is substantially equivalent to conventional x-ray film. Qualified readers evaluated both digital and analog films from various inpatient cases. Films were evaluated for overall image quality, as well as for image quality with respect to specific anatomical areas. The difference between image quality scores for digital and analog film consistently indicated that the quality of the two types of film was equivalent or that digital film was of higher quality. Several different statistical techniques were used to confirm this finding.

To evaluate the consistency of the study readers, a number of analog films were read twice by each reader, separated by a period of time. Results showed that readers were able to read the films in a consistent fashion, but that the magnitude of difference between their two readings was comparable to the difference between the two types of film.

It can be reasonably concluded that the image quality of films obtained with Canon's Digital Radiography System is substantially equivalent to that obtained with conventional analog film.

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Item	CXDI-11	Screen-Film system	Comment
Intended Use	Provide diagnostic images for general radiography use	Same	N/A
Design	Digital acquisition, electronic processing	Analog acquisition, chemical processing	N/A
Energy Uses	Receives x-radiation generated by external x-ray generator	Same	CXDI-11 operates from AC power sou
Materials	X-ray Absorber	Fluorescent screen(Gd₂O₂S:Tb³⁺)Visible emission peak : 545nm	Same	In Screen-Film system, a film sandwiched in between fluorescent screens, although a fluorescent screen is placed in front of the sensor panel in CXDI-11
	Sensing Means	Amorphous Silicon W/ TFT ArrayDetection peak: 540nm ~ 620nm	Silver halide filmDetection peak: 430nm ~ 680nm	Screen-Film system image is blurred with diffusion of two fluorescent screens which are placed both sides of film.
Anatomical Sites	General radiography	Same	N/A
Target Population	General population	Same	N/A

Table of comparison

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Physical Safety	Minimize exposure tox-radiation	Same	N/A
Compliance withstandards	Complies with IEC 601-1-2	N/A	N/A
Biocompatibility	N/A	N/A	N/A
Performance	After digital processing(optimize the gray-scale)	Development of film(use the own gray-scale)	CXDI-11 performs the digital image processing, and can optimize its image visualization even after exposure. Films Screen-Film system has their own H character, and its gray-scale is fixed exposure condition.
Labeling	See attached labeling	N/A	N/A
MTF	MTF@2lp/mm 42%	MTF@2lp/mm 33%(Lanex 250/TMS-RA)(Kodak)	The CXDI-11 sensor plate itself does not have blur theoretically.
Dynamic Range	Dynamic range:approximately 4 digit(linear A/D : 14 bit)(output data : 12 bit)	Dynamic range:approximately 1.5 digit	CXDI-11 can utilize wider dynamic range to control the image visualization.

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DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 4 1998

Ken Shadoff Senior Product Safety Engineer Quality Management Dept. Cannon U.S.A., Inc. One Cannon Plaza Lake Success, NY 11042-1198 Re:

K981556 Canon X-Ray Digital Camera CXDI-11 Dated: August 19, 1998 Received: September 14, 1998 Regulatory class: Unclassified Procode: 90 MOB

Dear Mr. Shadoff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrividsma/dsmamain.html".

Sincerely yours,

Lillian Yih

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

× 98 127 6 510(K)Number(if known):

Page of

Device Name: and CxnI - Il

Indications for Use:

CANON X-RAY DIGITAL CAMERA CXDI-11 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.

DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT GE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Elinil A. Symm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K981556

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.