(17 days)
DIGITAL RADIOGRAPHY CXDI-50C 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. This device is not intended for mammography applications.
The Canon digital radiography CXI)1-50C 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.
The provided text is a 510(k) summary for the Canon CXDI-50C digital radiography device. It describes the device, its differences from predicate devices, and the FDA's substantial equivalence determination. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance metrics that would directly answer most of the questions posed.
Based on the information provided, here's what can be extracted and what remains unknown:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics. It generally states that the CXDI-50C "achieves performance stated herein (such as image capturing, DICOM transfer and etc.)" but does not detail these performance metrics or how they were measured against specific criteria. It only highlights that the CXDI-50C's DQE approximately doubles compared to the CXDI-50G due to the use of CsI. This is a characteristic of the device, not a performance metric against a set of acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document.
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)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 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
This document describes a digital radiography capture device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or described here. No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes hardware (a digital radiography imager) and its ability to capture and convert X-ray images. It is not an algorithm evaluated for standalone performance. Therefore, this question is not applicable, and no such study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided document.
8. The sample size for the training set
This information is not present in the provided document.
9. How the ground truth for the training set was established
This information is not present in the provided document.
Summary of available relevant information from the text:
- Device: Canon CXDI-50C Digital Radiography Imager
- Purpose: Directly capture and convert conventional projection X-ray images to digital images, replacing film/screen systems in general purpose diagnostic procedures (not mammography).
- Key improvement over predicate (CXDI-50G): Uses CsI (Cesium Iodide) for the fluorescent screen instead of GOS (Gadolinium Oxy-Sulfide). This results in higher X-ray absorption, requiring less X-ray dosage, and the CXDI-50C's DQE (Detective Quantum Efficiency) approximately doubles compared to CXDI-50G.
- Comparison to CXDI-40C: Similar principle, modifications in housing size and shape. The sensor has the same characteristics, but the imaging area changed from 43x43cm to 35x43cm.
- Performance Claim: The device "achieves performance stated herein" for image capturing, DICOM transfer, etc., when used with a general-purpose computer and designated system software. However, specific metrics and acceptance criteria for these performances are not detailed.
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510(k) Summary
Prepared:
December 9, 2005
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 Fax Number: (516) 328-5169
Proposed Device:
Reason For 510(k): Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
New Model Canon Inc. Canon CXDI-50C MQB, Solid State X ray Imager To be assigned
Predicate Device:
Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon Inc. Canon CXDI-50G 90MQB, Solid State X ray Imager K031447
Manufacturer: Trade Name: Model Name: Classification Name: FDA 510(k) #:
Canon Inc. Canon CXDI-40C 90MQB, Solid State X-ray Imager KO31633
Description Of Device: The Canon digital radiography CXI)1-50C 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.
The Canon digital radiography CXDI-50C is different from CXDI-50G and CXDI-40C in the following respect:
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- The CXDI-50C is a portable unit as same as the CXDI-50G. It is positioned on a table or installed in a holder for a stand or a table during its operation as is the case with a film cassette, while the CXDI-40C operates in conjunction with an upright stand, table, and universal stand.
- · Both the CXDI-50C and the CXDI-50G use the same amorphous silicon alley as the sensing mcans, however, the 10-1
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Section 10: Summary
CXDI-50C uses the different material for fluorescent screen which is deposited on the amorphous silicon array with from the CXD1-50G. The CXDI-50C uses Csl (Cesium Iodide) while CXD1-50G uses GOS (Gadolium Oxy-Sulfide). Because of CsI which provides high xray absorption as fluorescent screen, CXDI-50C delivers diagnostic images with the x ray dosage less than that required by CXDI-50G and CXDI-50C's DQE approximately doubles compared to CXDI-50G.
The principle of the CXI)I-50C is the same as the CXDI-40C, with some modifications of its housing in size and shape. The sensor of the CXDI:50C has the same characteristics as the CXDI:40C and the imaging area is changed from 43x43cm to 35x43cm.
The CXDI-50C 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-50C achieves performance stated herein(such as image capturing, DICOM transfer and etc.)
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms.
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. % Mr. Morten S. Christensen Program Reviewer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995
Re: K060433
AUG 2 3 2013
Trade/Device Name: CXDI-50C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 8, 2006 Received: February 21, 2006
Dear Mr. Christensen:
This letter corrects our substantially equivalent letter of March 10, 2006.
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. Morri 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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Indications for Use
510(k) Number (if known): K060433
Device Name: CXDI-50C
Indications For Use:
DIGITAL RADIOGRAPHY CXDI-50C 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. This device is not intended for mammography applications.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ancyc broston
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
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§ 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.