(158 days)
The Digital Retinal Camera CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free, cobalt digital and fundus autofluorescence (FAF).
The Digital Retinal Camera CR-2 Plus AF is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-2 Plus AF. Images can be viewed immediately, and procedures of imaging are more efficient with many different applications such as telemedicine and electronic filing. The CR-2 Plus AF is equipped with autofocus/automatic shooting/automatic switching function from anterior segment image to fundus image.
The provided text describes a 510(k) summary for the "Digital Retinal Camera CR-2 Plus AF." This document outlines the device's technical characteristics, its intended use, and a comparison to a predicate device (K111612 Canon Digital Retinal Camera CR-2 Plus). However, it focuses on the device's safety and effectiveness being substantially equivalent to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.
The essential information requested in the prompt, such as detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is largely absent from this type of regulatory submission for a non-AI medical imaging device.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that "The unit complies with the US Performance Standard for ophthalmic equipment" and "The CR-2 Plus AF met all requirements of the standards," but it does not specify what those standards are or what the acceptance criteria within them entailed. No specific device performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the AF function.
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 provided. The document mentions "non-clinical tests were performed" to evaluate safety and effectiveness, but it does not specify a test set size or data provenance.
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 provided. Since this is an imaging device rather than a diagnostic AI, there is no mention of establishing ground truth by experts in the context of diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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 is not applicable and not mentioned. The device is a digital retinal camera, and the modifications are related to autofocus, automatic shooting, and automatic switching, not AI assistance for human readers in diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable and not mentioned. The device is an imaging camera, not an AI algorithm. Its automated features (autofocus, auto-shooting) are inherent to its operation, not a separate standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This is not applicable and not mentioned in the context of diagnostic interpretation. For the device itself, the "ground truth" for its performance would be its ability to capture clear images according to technical specifications and safety standards, but these details are not elaborated upon.
8. The sample size for the training set:
This information is not provided. As this is not an AI/machine learning device, there wouldn't typically be a "training set" in the common sense.
9. How the ground truth for the training set was established:
This information is not provided. (Not applicable for this type of device.)
Summary of Device and Performance Information from the Text:
The document describes the Canon Digital Retinal Camera CR-2 Plus AF, an ophthalmic camera used for taking digital images of the human retina without mydriatic.
Acceptance Criteria and Device Performance (as inferred):
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (from K123208) |
|---|---|
| Safety: Device operates without causing harm to patients or users. | Non-clinical tests performed, including Electrical safety and Electromagnetic Compatibility testing. Does not raise new safety concerns compared to predicate. |
| Effectiveness: Device captures digital images of the human retina as intended. | Performance testing performed. Complies with US Performance Standard for ophthalmic equipment. Met all requirements of standards. |
| Technological Characteristics: New features (Autofocus, Automatic shooting, Automatic switching) function correctly and reliably. | Modifications (autofocus, auto-shooting, auto-switching) implemented. Non-clinical testing results indicated the CR-2 Plus AF met all requirements of recognized or voluntary standard. |
| Substantial Equivalence: Device is equivalent to predicate device (CR-2 Plus) despite modifications. | Canon Inc. concluded CR-2 Plus AF is substantially equivalent, based on identical intended use, fundamental technological characteristics, and similarities in functional design. |
Key Takeaways from the document:
- This is a 510(k) premarket notification for a medical imaging device (digital retinal camera), not an AI diagnostic tool.
- The focus of the submission is to demonstrate substantial equivalence to an existing predicate device (K111612 Canon Digital Retinal Camera CR-2 Plus).
- The "study" referenced involves non-clinical tests (performance, software validation, electrical safety, electromagnetic compatibility) to ensure the modified device (CR-2 Plus AF) remains safe and effective despite added features like autofocus and automatic shooting.
- The document states the device "met all requirements of the standards" and "does not raise any new safety and effectiveness concerns." However, it does not detail specific quantitative performance metrics beyond this general statement of compliance.
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5. 510(k) Summary
K123208
MAR 1 9 2013
| Submitter: | Canon, Inc. - Medical Equipment Group30-2 Shimomaruko, 3-chomeOhta-ku, Tokyo 146-8501 Japan |
|---|---|
| Contact Person: | Naoyasu AsakaManagerTEL: 81-3-3758-2111FAX: 81-3-5482-3960asaka.naoyasu@canon.co.jp |
| Contact/ApplicationCorrespondent | Izumi MaruoMIC International4-1-17 Hongo, Bunkyo-ku,Tokyo, 113-0033, JapanTEL: 81-3-3818-8577FAX: 81-3-3818-8573maruo@mici.co.jp |
| Date Prepared: | October 10, 2012 |
| Trade Name: | Digital Retinal Camera CR-2 Plus AF |
| Common Name: | Ophthalmic camera |
| Classification Name: | Ophthalmic camera. (21 CFR 886.1120, Product code HKI) |
| Regulation Class | II |
| Predicate Device: | K111612 Canon Digital Retinal Camera CR-2 Plus |
| Device Description: | The Digital Retinal Camera CR-2 Plus AF is used for taking digitalimages of a human retina without a mydriatic. Canon EOS DigitalCamera is mounted to the CR-2 Plus AF. Images can be viewedimmediately, and procedures of imaging are more efficient with manydifferent applications such as telemedicine and electronic filing. TheCR-2 Plus AF is equipped with autofocus/automaticshooting/automatic switching function from anterior segment image tofundus image. |
| Statement ofIntended Use: | The CR-2 Plus AF is intended to be used for taking digital images ofthe retina of the human eye without a mydriatic. The CR-2 Plus AF hasthe following photography modes: color, red free, cobalt digital andfundus autofluorescence (FAF). |
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Image /page/1/Picture/0 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly curved, with the "C" being the highest point and the "n" being the lowest point. The letters are evenly spaced and easy to read.
Modification from predicate device
The CR-2 Plus AF is modified from the CR-2 Plus by adding following functions;
- Autofocus of the fundus image .
- . Automatic shooting of the fundus image
- Automatic switching from anterior segment image to fundus image .
In addition, the "diopter compensation knob" is removed since diopter compensation is performed using the focus ring instead of the diopter compensation knob in the CR-2 Plus AF.
The CR-2 Plus AF has the same intended use and fundamental technological characteristics as the CR-2 Plus. However, the CR-2 Plus AF has some different technological characteristics compared to the CR-2 Plus as described above. In order to evaluate safety and effectiveness of the CR-2 Plus AF, non-clinical tests were performed. In conclusion, result of the testing demonstrated that the CR-2 Plus AF does not raise any new safety and effectiveness concerns compared to the CR-2 Plus.
Non-clinical tests were conducted to evaluate safety and effectiveness of the CR-2 Plus AF as follows. Performance testing, Software Validation, Electrical safety, and Electromagnetic Compatibility testing have been performed. The unit complies with the US Performance Standard for ophthalmic equipment. The CR-2 Plus AF met all requirements of the standards.
Canon. Inc. - Medical Equipment Group concluded that the CR-2 Plus AF is substantially equivalent to the predicate device listed above. This conclusion is based on the identical intended use and fundamental technological characteristics, and the similarities in the functional design. Although the CR-2 Plus AF has some different technological characteristics from the predicate, the non-clinical testing results indicated that the CR-2 Plus AF met all requirements of recognized or voluntary standard. Based on the test results. the CR-2 Plus AF does not raise any new safety and effectiveness concerns compared to the CR-2 Plus.
Statement of Substantial Equivalence
Summary of Non-Clinical/Test Data:
Conclusion:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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March 19, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Canon Inc. Medical Equipment Group % Izumi Maruo MIC International Corp. 4-1-17 Hongo Bunkyo-ku, Tokyo 113-0033
Re: K123208
Trade/Device Name: Digital Retina Camera CR-2 Plus AF Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: March 5, 2013 Received: March 7, 2013
Dear Izumi Maruo:
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. 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.
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
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Page 2 - Izumi Maruo
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,
Kesia YAlexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic 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): K123208
Device Name: Digital Retinal Camera CR-2 Plus AF
Indications For Use:
The Digital Retinal Camera CR-2 Plus AF is intended to be used for taking digital images of the retina of the human eye without a mydriatic. The CR-2 Plus AF has the following photography modes: color, red free, cobalt digital and fundus autofluorescence (FAF).
Prescription Use X (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)
Ka N. To
2013.03.14 08:54:22 -04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:________________________________________________________________________________________________________________________________________________________________
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§ 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.