The DIGITAL RETINAL CAMERA CX-1 is used for taking digital images of retina of human eye with non-mydriatic and mydriatic. is mounted with CX-1, can be viewed immediately, making Digital Camera (Dedicated) procedures more efficient and many different applications, such as telemedicine and electronic filing.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Canon CX-1 Digital Retinal Camera, seeking substantial equivalence to existing predicate devices (Canon CF-1 and CR-1). The document focuses on demonstrating that the CX-1 is as safe and effective as the predicates through a comparison of device features and performance data.

However, the provided document does not contain any information about acceptance criteria or a study that evaluates the device's performance against such criteria in the context of diagnostic accuracy, clinical outcomes, or human reader improvement with AI assistance.

The "Performance Data" mentioned in the "Conclusion" section likely refers to technical performance data (e.g., image quality, safety tests) related to the device itself and its ability to capture images, rather than a clinical study evaluating diagnostic performance. The context of a 510(k) submission generally involves demonstrating substantial equivalence by comparing technical specifications and intended use, not necessarily by conducting extensive clinical efficacy trials against specific performance criteria for AI-driven diagnostic outputs.

Therefore, I cannot fulfill most of the requested information based on the provided text.

Here's what can be inferred or stated as not available from the document:

Table of acceptance criteria and the reported device performance:
- Not available. The document does not specify any quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) nor does it report such metrics for the CX-1. The "Performance Data" is vaguely mentioned as demonstrating safety and effectiveness, likely related to technical device operation.
Sample size used for the test set and the data provenance:
- Not available. There is no mention of a "test set" in the context of evaluating diagnostic performance. The document describes the device, its intended use (taking digital images), and compares its features to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. No test set is described, and therefore no ground truth establishment by experts is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available. No test set or adjudication process is described.
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 available. The CX-1 is a digital retinal camera, not an AI-powered diagnostic system. The document does not describe any MRMC studies or AI involvement.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not available. The CX-1 is a camera, not an algorithm, and the document does not discuss standalone algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not available. No ground truth for diagnostic performance is mentioned.
The sample size for the training set:
- Not available. Since the device is a camera and not an AI algorithm requiring training, there is no mention of a training set.
How the ground truth for the training set was established:
- Not available. As above, no training set is mentioned.

Summary based on the provided text:

The Canon CX-1 Digital Retinal Camera is a device for taking digital images of the human retina. Its 510(k) submission demonstrates substantial equivalence to predicate devices (Canon CF-1 and CR-1) by comparing its features (mydriatic/non-mydriatic capabilities, angle of view, photography modes, bundled digital camera) and stating that "Performance Data" (likely technical and safety data) demonstrates it is as safe and effective as the predicates. The document focuses on the device's ability to capture images, not on image interpretation or diagnostic accuracy performance.

Summary

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Appendix G: Summary

510(k) Summary

Prepared:

June 29, 2009 -

MAR 1 8 2010

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 Sheila Driscoll (from U.S. agent for Canon Inc.) 516-328-5602 516-328-2169

Proposed Device:

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

New Model Canon CX-1 86HKI Ophthaimic camera 86NFJ System, image management, ophthalmic To be assigned

FDA 510(k) #:

Predicate Device:

Trade Name: Model Name: Classification Name: FDA 510(k) #:

Canon CF-1 86HKI Ophthalmic camera K063717

Canon CR-1 86HKI Ophthalmic camera K080883

Description of Device:

The DIGITAL RETINAL CAMERA CX-1 is used for taking digital images of retina of human eye with non-mydriatic and mydriatic.

is mounted with CX-1, can be viewed immediately, making Digital Camera (Dedicated) procedures more efficient and many different applications, such as telemedicine and electronic filing.

Intended Use:

The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.

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Appendix G: Summary

Comparison to Predicate:

The differences between CX-1 and CF-1 and CR-1 are as follows;

	CX-1	CF-1	CR-1
Type	MydriaticNon-Mydriatic	Mydriatic	Non-Mydriatic
Angle of view	Mydriatic: 50 degreeNon-Mydriatic: 45 degree	Mydriatic: 50 degree	Non-Mydriatic: 45 degree
Photographymode	<5 modes>COLORFLUORED FREECOBALTFAF**Fundus Autofluorescenceangiography	<4 modes>COLORFLUORED FREECOBALT	<1 mode>COLOR
AttachableDigital camera	Bundled	None	None

Conclusion:

The Performance Data demonstrate that CX-1 is as safe and effective as the predicate devices. The I crorination Data demonstrate marsion, similarity to the predicate devices (the DIGITAL DESC on the michilance in 1 and the DIGITAL RETINAL CAMERA CR-1), and the results of our design control activities and non-clinical testing, it is the opinion of Canon Inc. that the DIGITAL RETINAL CAMERA CX-1 described in this submission is substantially equivalent to the predicate devices.

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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 features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol consisting of three overlapping, curved shapes, resembling a person embracing another person.

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

Canon, Inc. c/o Mr. Jeff D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Dr. Research Triangle, NC 27709

MAR 1 8 2010

Re: K092565

Trade/Device Name: Digital Retinal Camera CX-1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Codes: HKI, NFJ Dated: March 2, 2010 Received: March 3, 2010

Dear Mr. Rongero:

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 Amendmonte, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr to 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 misbranching 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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, EDA on a 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-1050.

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ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander Jr

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

Kog2565 510(K)Number (if known) :

Device Name: CX-1

Indications for Use:

The device is intended to be used for taking digital images of retina of human eye with non-mydriatic and mydriatic.

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

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

DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF

Concurrence of CDRH, Office of Device Evaluation(ODE)

Ralfo

(Division Sign Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092565

Page 1 of 1

Regulation Number and Section

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.