The Digital Radiography CXDI-501G and CXDL-501C are solid state x-ray imagers which have 35.0 x 42.6 cm imaging area. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated it is converted to digital value. and the images will be displayed on monitors.

The CXDI-501G uses GOS (Gadolium Oxy-Sulfide) as the material for fluorescent screen, while CXDI-501C uses Csl (Cesium Iodide) which provides high x-ray absorption as fluorescent screen. Both models employ housing for easy installation in stand and table unit.

AI/ML Overview

The provided text, K111682, does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt's request. This document is a 510(k) summary for a medical device (Digital Radiography CXDI-501G and CXDI-501C) and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a detailed clinical or standalone performance study.

Here's an analysis of the provided information based on your requested points:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics like sensitivity, specificity, accuracy, or AUC. Instead, it states:

Acceptance Criteria (Implied)	Reported Device Performance
Safety & Effectiveness	"demonstrated that these devices are safe and effective"
Equivalence to Predicate Devices	"are equivalent to the predicate devices" "are as safe and effective as the predicate devices" "are substantially equivalent to the predicate devices"
Compliance with Electrical Safety and EMC	"The Electrical safety, Electromagnetic compatibility and other performance testings were performed"

The primary "acceptance criterion" in this 510(k) submission is substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as those existing devices.

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

The document does not describe a test set or data from human subjects. The performance testing mentioned refers to electrical safety, electromagnetic compatibility, and "other performance testings" which are typically non-clinical, bench-top tests, and do not involve patient data.

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 test set involving human data or expert review for ground truth is described.

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

Not applicable. No test set requiring adjudication 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

Not applicable. The document describes a digital radiography system, not an AI-assisted diagnostic tool. No MRMC study involving human readers or AI is mentioned.

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

Not applicable. This is a digital radiography device, not a standalone algorithm. The "performance testing" mentioned refers to the physical device's characteristics (electrical safety, EMC) rather than a diagnostic algorithm's performance.

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

Not applicable. There is no mention of a diagnostic performance study that would require establishing a "ground truth" for medical conditions. The "performance testing" relates to the device's operational characteristics.

8. The sample size for the training set

Not applicable. This document describes a hardware device (digital X-ray imager), not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is not an algorithm requiring a training set.

Summary of Document Focus:

The K111682 document is a Pre-Market Notification (510(k)) that focuses on demonstrating "substantial equivalence" of the new Digital Radiography CXDI-501G and CXDI-501C devices to previously cleared predicate devices. The arguments are based on:

Same intended use: Digital image capture for general purpose diagnostic procedures, replacing film/screen systems.
Similar imaging principle: Solid state X-ray imagers using scintillator materials (GOS or CsI) to convert X-rays to visible light, then to electrical signals, and finally to digital images.
Performance testing: This testing primarily refers to non-clinical evaluations such as electrical safety, electromagnetic compatibility (EMC), and other technical parameters to ensure the device is safe and performs comparably to the predicate devices on a technical level. It does not involve clinical performance metrics (e.g., diagnostic accuracy in detecting diseases) derived from human patient data.

Therefore, this document does not contain the type of detailed study data regarding acceptance criteria for diagnostic performance that your prompt is seeking.

Summary

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K111682
Page 1 of 2

Section 5: 510(k) Summary

510(k) Summary

SEP - 2 2011

Prepared:

June 14, 2011

Submitter/Holder:

Company Name: Company Address:

Contact Person: Phone Number: Fax Number:

CANON INC. 30-2 Shimomaruko 3-chome, Ohta-ku Tokyo 146-8501, Japan Naoyasu Asaka 81-3-3758-2111 81-3-5482-3960

Proposed Device:

Reason For 510(k): Trade Name: Model Name:

Classification Name: FDA 510(k) #:

New Model Canon Digital Radiography CXDI-501G Digital Radiography CXDI-501C 90MQB, Solid State X-ray Imager To be assigned

Predicate Device:

Trade Name: Canon

FDA 510(k) #/Model Name:

K 103591/ Digital Radiography CXDI-401G COMPACT/CXDI-401C COMPACT K091436/ Digital Radiography CXDI-55C K091435/ Digital Radiography CXDI-55G Classification Name: 90MOB, Solid State X-ray Imager

Description of Device:

Intended Use:

The Digital Radiography CXD1-501G and CXD1-501C provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.

Comparison to Predicate:

The imaging principle and intended use of the Digital Radiography CXDI-501G and CXDI-501C are the same as those of the predicate devices (Digital Radiography CXDI-401G COMPACT, CXDI-401C COMPACT, CXDI-55C or CXDI-55G).

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K 111\1682
Page 2 of 2

Section 5: 510(k) Summary

Performance testing:

The Electrical safety, Electromagnetic compatibility and other performance testings were performed on these devices which demonstrated that these devices are safe and effective, and are equivalent to the predicate devices.

Conclusion:

The Performance Data demonstrate that CXDI-501G and CXDI-501C are as safe and effective as the predicate devices (Digital Radiography CXD1-401G COMPACT, CXDI-401C COMPACT, CXDI-55C or CXDI-55G). Based on the information in this submission, similarity to the predicate devices, and the results of our design control activities and non-clinical testing, it is our opinion that the Digital Radiography CXDI-501G and CXDI-501C described in this submission are substantially equivalent to the oredicate devices.

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol with three figures and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" to the right of the symbol. The symbol and text are in blue.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Naoyasu Asaka Staff manager Canon Inc. 30-2 Shimomaruko 3-Chrome OHTA-KU TOKYO 146-8501 JAPAN

AUG 2 3 2013

Re: K111682

Trade/Device Name: Canon/Digital Radiology, CXDI-501G/CXDI-501C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: June 27, 2011 Received: June 28, 2011

Dear Mr. Asaka:

This letter corrects our substantially equivalent letter of September 2, 2011.

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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Page 2

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 requirents as set form in the quality of the seescribed in your Section 510(k) premarket will anow you to begin marketing your avrile as valence of your device to a legally marketed noutication. The IDA imanig of succion 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 If you desire specific advice for your device of the engles Eyaluation and Safety at (301) 796-607), prease vonaot 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 under the MDK regulation (27 CFFF at 065), processor of 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 Tour may 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

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): ____________________________________________________________________________________________________________________________________________________

Device Name: CXDI-501G and CXDI-501C

Indications for Use:

DIGITAL RADIOGRAPHY CXDI-501G and CXDI-501C provide digital image capture for conventional film/screen radiographic examinations.

These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

These devices are not intended for mammography applications.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Page ー of 1

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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.