The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Canon DIGITAL RETINAL CAMERA CR-2:

It's important to note that this 510(k) summary is for a medical device, specifically a digital retinal camera, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details associated with AI/ML systems (like those for diagnostic accuracy, sensitivity, specificity, reader studies, ground truth establishment for algorithms, etc.) are not present in this document. The focus here is on safety, effectiveness, and substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Criterion	Reported Device Performance
Electrical Safety	Compliance with IEC60601-1	CR-2 was tested in accordance with IEC60601-1 and was found to meet all requirements of this standard.
Electromagnetic Compatibility (EMC)	Compliance with IEC60601-1-2	CR-2 was tested in accordance with IEC60601-1-2 and was found to meet all requirements of this standard.
Ophthalmic Instruments Requirements (General)	Compliance with ISO15004-1:2006	CR-2 was tested in accordance with ISO15004-1:2006 and was found to meet all requirements of this standard.
Ophthalmic Instruments Requirements (Specific)	Compliance with ISO15004-2:2007	CR-2 was tested in accordance with ISO15004-2:2007 and was found to meet all requirements of this standard.
Substantial Equivalence	Same imaging principle and intended use as predicate.	The CR-2's imaging principle and intended use are the same as those of CR-1 Mark II. The CR-2 has reduced dimensions and weight compared to the CR-1 Mark II. The optical components, alignment, and most specifications are the same or better than the CR-1 Mark II. The Performance Data demonstrate that CR-2 is as safe and effective as the predicate devices. Based on this, it is considered substantially equivalent to the predicate device (CR-1 Mark II).

Study Details (Focusing on the type of device and available information)

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 specify a "test set" in the context of clinical image data for evaluating an algorithm's performance. Instead, the testing described is related to engineering and safety standards.
- Therefore, there is no information on sample size, data provenance, or retrospective/prospective nature for an image-based test set as this is not an AI/ML diagnostic device.
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. This device is an imaging acquisition device, not an AI/ML diagnostic algorithm that requires expert-established ground truth for performance evaluation of its diagnostic capabilities.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no diagnostic "test set" and thus no adjudication of cases by experts for this type of submission.
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. This device is a fundus camera, not an AI-assisted diagnostic tool. No MRMC study was performed in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm. The device's "standalone" performance refers to its ability to acquire images and meet technical standards independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device lies in its adherence to established engineering and safety standards (e.g., electrical safety, EMC, ophthalmic instrument standards) and its functional equivalence to a predicate device in terms of image acquisition. There is no medical "ground truth" (like disease presence/absence via pathology) used in evaluating its performance for this 510(k) submission.
The sample size for the training set:
- Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The "training" for such a device would refer to its manufacturing and design process.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI/ML algorithm.

Summary of the Study:

The "study" described in this 510(k) pertains to performance testing against recognized industry standards and direct comparison of specifications to a predicate device, the Canon DIGITAL RETINAL CAMERA CR-1 Mark II (K090466).

Testing Protocol: The CR-2 underwent testing in accordance with:
- IEC60601-1 (Electrical Safety)
- IEC60601-1-2 (Electromagnetic Compatibility)
- ISO15004-1:2006 (Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General requirements applicable to all ophthalmic instruments)
- ISO15004-2:2007 (Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection)
Purpose of Study: To demonstrate that the CR-2 meets all safety and performance requirements set by these standards and is substantially equivalent to its predicate device. This ensures it is as safe and effective for its intended use (taking digital images of the retina of the human eye without a mydriatic).
Methodology: The device itself was subjected to these standard tests. A direct comparison of its imaging principle, intended use, dimensions, weight, optical components, alignment, and other specifications was made against the predicate device.
Conclusion: The tests confirmed compliance with the standards, and the comparison showed that the CR-2 maintains the same or better performance than the predicate, leading to a determination of substantial equivalence.

Summary

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Klozoi3

Section 5: Summary

Tokyo 146-8501, Japan Naoyasu Asaka

OCT 2 9 2010

Section 5. 510(k) Summary

Prepared:

July 15, 2010

Canon Inc.

81-3-3758-2111 81-3-5482-3960

Submitter:

Company Name: Company Address:

Contact Person: . Phone Number: Fax Number:

Proposed Device:

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

New Model Canon DIGITAL RETINAL CAMERA CR-2 86HKI, Ophthalmic camera To be assigned

30-2 Simomaruko 3-chome, Ohta-ku

Predicate Device:

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

Canon

DIGITAL RETINAL CAMERA CR-1 MarkIl 86HKI, Ophthalmic camera K090466

Description of Device:

The DIGITAL RETINAL CAMERA CR-2 is used for taking digital images of retina of human eye without a mydriatic.

Canon EOS Digital Camera is mounted to the CR-2. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

Intended Use:

The device is intended to be used for taking digital images of the human eye without a mydriatic.

Comparison to Predicate:

The CR-2's imaging principle and intended use are the same as those of CR-1 Mark II. The CR-2 is reduced dimensions and weight as compared with the CR-1 Mark II. The optical components, alignment and most of the specifications are the same or better than CR-1 Mark II.

Performance testing:

The following testing was performed on the DIGITAL RETINAL CAMERA CR-2 to demonstrate that it meets all requirements and is equivalent to the predicate device:

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Section 5: Summary

Electrical Safety & Electromagnetic Compatibility

CR-2 was tested in accordance with IEC60601-1 and IEC60601-1-2, and was found to meet all requirements of these standards.

Requirements for Ophthalmic instruments

CR-2 was tested in accordance with ISO15004-1:2006 and ISO15004-2:2007, and was found to meet all requirements of these standards.

Conclusion:

The Performance Data demonstrate that CR-2 is as safe and effective as the predicate devices. Based on the information in this submission, similarity to the predicate device (CR-1).cos. II), and the results of our design control activities, it is our opinion that the DIGITAL RETINAL CAMERA CR-2 described in this submission is substantially equivalent to the predicate device.

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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 consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the left side of the logo. The text and the bird symbol are both in black.

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

Canon, Inc. c/o Mr. Koji Kubo, Manager Cosmos Corporation, Tokyo Office 3F, 2-17-6 Akebono-cho Tachikawa-shi, Tokyo 190-0012 Japan

0CT 2 9 2010

Re: K102013

Trade/Device Name: Digital Retinal Camera, Model CR-2 Regulation Number: 21 CFR 886.1120 Regulation Name: Opthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: October 21, 2010 Received: October 22, 2010

Dear Mr. Kubo:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Mr. Koji Kubo

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 1000-1050.

If 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Debra Falls

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 for Use

. .

510(K) Number (if known):	K102013
Device Name:	CR-2

OCT 2 9 2010

Indications for Use:

The device is intended to be used for taking digital images of the retina of the human eye without a mydriatic.

Prescription Use(Part 21 CFR 801 Subpart D)	X
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Over-The-Counter Use(Part 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

	Page 1 of 1
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

. .

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.