CF-60DSi is an improved model of CF-60UVi. The DIGITAL FUNDUS Doorfpack CF-60DSi is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted with CF-60DSi, can be viewed immediately, making oundly 200 Digitiont and 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 CF-60DSi Digital Fundus Camera:

This 510(k) submission (K041546) is for a modified device, the Canon CF-60DSi, which is being compared to its predicate device, the Canon CF-60UVi. The core of this submission is to demonstrate substantial equivalence rather than defining and proving acceptance criteria for a novel device. Therefore, a traditional "acceptance criteria and study that proves the device meets the acceptance criteria" in the sense of a new, groundbreaking AI-powered diagnostic device with specific performance metrics (like sensitivity, specificity, AUC) is not present. Instead, the focus is on a comparison table highlighting the similarities and minor differences between the new model and the previously cleared predicate device.

The "acceptance criteria" here are implicitly tied to the performance and safety profile of the predicate device, CF-60UVi, which has already been deemed safe and effective. The study proving equivalence is the detailed comparison provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the CF-60DSi itself are not stated in this 510(k) summary because it's a device modification submission rather than a new technology validation. The "performance" being evaluated is its equivalence to the predicate device.

Aspect	Acceptance Criteria (Implied by Predicate)	Reported CF-60DSi Performance
Intended Use	Taking pictures of the retina of the human eye (with a mydriatic)	Same (Taking digital images of retina of human eye with a mydriatic)
Optical Components & Alignment	Equivalent to CF-60UVi	Same
Mechanical Structures	Almost same as CF-60UVi	Almost same
Angle of View	60/40/30° (CF-60UVi)	60/40° (CF-60DSi)
Actual Image Size	φ29x22 (on 35mm film); φ7.5x5.7 (Type 1: on sensor array)	Same (on monitor / on sensor array)
Min. Pupil Diameter Required	φ5.5mm (60/40/30°); φ4.0mm (with S.P switch ON in 30°) (CF-60UVi)	Same (60/40°); φ4.0mm (with S.P switch ON in 40°) (CF-60DSi)
Working Distance (WD)	45mm	Same
Focusing	By aligning the split lines	Same
Eye Fixation Lamp	External	Same
Filter Set	Automatic/Manual	Same
Light Source for Photography	Max. 300WS	Same
Image Unit Integration	EOS Digital Camera (with Adapter) (CF-60UVi)	EOS Digital Camera (Directly)
Physical Safety	UL544 (CF-60UVi)	UL60601-1 (CF-60DSi)
Compliance with Standards	UL544 (CF-60UVi)	UL60601-1 (CF-60DSi)

Explanation of Deviations/Differences:
The CF-60DSi is an improved model primarily in its integration of the EOS digital camera directly, simplifying the process. It also has two variable powers (60/40 degrees) compared to the CF-60UVi's three (60/40/30 degrees), and it uses the updated medical safety standard UL60601-1 instead of UL544. These differences are presented to FDA for review, and the conclusion of substantial equivalence indicates these differences do not raise new questions of safety or effectiveness.

Regarding AI/ML Specifics (as per your prompt structure):

This device (Canon CF-60DSi Digital Fundus Camera, submitted in 2004) is a conventional medical imaging device. It does not employ AI or Machine Learning (ML) functionalities. Therefore, the following points related to AI/ML specific studies are not applicable (N/A) to this 510(k) submission.

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

N/A. This is not an AI/ML device that generates diagnostic output based on a test set. The "test" for this device involved comparing its physical and performance specifications to a predicate device.

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)

N/A. No diagnostic "ground truth" establishment by experts is described as this is not an AI/ML diagnostic device.

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

N/A. No adjudication method for diagnostic results from an AI/ML algorithm.

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

N/A. No MRMC study was conducted as this device does not provide AI assistance for human readers.

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

N/A. No standalone algorithm performance study was done as there is no algorithm for diagnostic output.

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

N/A. No diagnostic ground truth is mentioned. The "ground truth" for comparison is the established performance and safety of the predicate device (CF-60UVi).

8. The sample size for the training set

N/A. No training set exists for this conventional imaging device.

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

N/A. No training set ground truth to establish.

Summary Conclusion for K041546:

The Canon CF-60DSi is a modified conventional fundus camera. Its "acceptance criteria" are implicitly met by demonstrating substantial equivalence to its predicate device, the CF-60UVi, which was already cleared for market. The study proving this "acceptance" is the detailed comparison in the 510(k) summary, which outlines the specifications and features of both devices. The FDA's clearance (JUN 23 2004) confirms this substantial equivalence. As this is not an AI/ML-powered device, the AI-specific questions are not applicable.

Summary

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K041546

Section G: Summary

510(k) Summary

Prepared:

March 31, 2004

Submitter:

Company Name:	Canon USA, Inc. (U.S. agent for Canon Inc.)
Company Address:	One Canon PlazaLake Success, NY 11042
Contact Person:	Ms. Sheila Driscoll
Phone Number:	(516) 328-5602
Fax Number:	(516) 328-5169

Proposed Device:

Reason For 510(k):	New Model
Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CF-60DSi
Classification Name:	86HKI, Ophthalmic cameras
FDA 510(k) #:	To be assigned

Predicate Device:

Manufacturer:	Canon Inc.
Trade Name:	Canon
Model Name:	CF-60UVi
Classification Name:	86HKI, Ophthalmic cameras
FDA 510(k) #:	K946058

CF-60DSi is intended to be used for taking digital images pictures of retina Intended Use: of human eye with a mydriatic.

Description Of Device: CF-60DSi is an improved model of CF-60UVi. The DIGITAL FUNDUS Doorfpack CF-60DSi is used for taking digital images of retina of human eye without a mydriatic. Canon EOS Digital Camera is mounted with CF-60DSi, can be viewed immediately, making oundly 200 Digitiont and many different applications, such as telemedicine and electronic filing.

The CF-60DSi's intended use is the same as that of CF-60UVi. However, the differences in design are as follows:

EOS digital camera can be attached to the main unit of CF-60DSi directly. But CF-60UVi . cannot be attached without an adapter.
cannot of attached while at and mount of CF-60DSi with the adapter. The . 100 angliar cambera can be attached to the sub mount of CF-60UVi with the adapter, and 35mm camera can be attached with the 35mm double adapter, and also Polaroid film unit can be attached without the adapter.
While CF-60DSi has 2 variable powers (60/40 degree), CF-60UVi has 3 variable powers (60/40/30 degree).
A data card cannot be used. •

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K041546

Section G: Summary

CF-60DSi is equivalent to CF-60UVi in the following respect:

The optical components and alignment. .
The optical components and allgament.
The mechanical structures of the CF-60DSi are almost same as the CF-60UVi. Please refer to . the CF-60DSi comparison table provided in this section.

			Table of comparison
			CF-60UVi	CF-60DSi
PERFORMANCE	Angle of view		60/40/30°	60/40°
		Actual image size	$$\phi$ 29×22(on 35mm film)	Same(on monitor)
			$$\phi$ 7.5×5.7(Type 1:on sensor array)	Same
			$$\phi$ 4.9×3.7(Type 2:on sensor array)	No Applicable
			$$\phi$ 75×57(on Polaroid film)	No Applicable
		Min. diameter of pupilrequired	$$\phi$ 5.5mm(60/40/30°)	Same(60/40°)
			$$\phi$ 4.0mm(with S.P switch ON in 30°)	$$\phi$ 4.0mm(with S.P switch ON in 40°)
		Working distance(WD)	45mm	Same
		Focusing	By aligning the split lines	Same
		Data to be printed	Hand-written data	No Applicable
	Eye fixation lamp		External	Same
	Filter set		Automatic/Manual	Same
	Light source forphotography		Max. 300WS	Same
	Image unit		EOS Digital Camera(with Adapter)	EOS Digital Camera
			CCD camera(with Adapter)	No Applicable
			3CCD camera(with Adapter)	No Applicable
			35mm film unit	No Applicable
			Polaroid film unit	No Applicable
			No Applicable	ICG digital camera(with Adapter)
	Working rangeVerticalForward and backRight and leftChin rest (vertically)		38mm	Same
			70mm	Same
			120mm	Same
			65mm	Same

	Panning		30° right or left	Same
	External dimensions
	Main unit		W320×D560×H565mm	Same
	Power control unit		W225×D390×H520mm	W225×D380×H485mm
	Weight
	Main unit		Approx.26kg	Approx.27kg
	Power control unit		Approx.30kg	Approx.27kg
	Intended use		Taking picture of retina of human eye	Same
	Energy

	used		1000VA	Same
	delivered		No Applicable	Same
	Target population		Ophthalmologist	Same
	Physical safety		UL544	UL60601-1
	Compliance with standards		UL544	UL60601-1
	Biocompatibility		No Applicable	Same
	LabelingPackaging		Printed model name is changed

Table of comparison

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2004

Canon, Inc. c/o Glenn M. Luchen Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747

K041546 Re:

K041540
Trade/Device Name: Digital Fundus Camera, Model CF-60DSi Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic camera Regulatory Class: Class II Product Code: HKI Dated: June 7, 2004 Received: June 9, 2004

Dear Mr. Luchen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section JTV(K) premainer in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate ferenced above and nave determined the arrest and devices marketed in interstate for use stated in the encrosule, to regally mancess promotical Device Amendments, or to commerce prior to May 20, 1970, the characted with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous of the Act . The and Cosment Act (Act) that to not require approval controls provisions of the Act. The You may, merelore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the frectines and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) inl. - Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation E may be subject to such additional controls: Extrems - 1998 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Federal Regarations, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ Issualitat equr device complies with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a delemination and regulations administered by other Federal and listing or any Federal statutes and regulations administed to: registration and listing requirements a comply with all the Act S requirements, metals), good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the electro (2) CFR Part 807); labellig (21 CFR Patt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electr torth in the quality systems (QD) regalaten (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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Page 2 - Glenn M. Luchen

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow your to ough finding of substantial equivalence of your device to a legally premarket notification: "The Director on on 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 Part 801), please If you desire specific and Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. halyi Rosenthal

A. Ralph Rosenthal, 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 Statement

510(K)Number(if known):	K041546
-------------------------	---------

Device Name: CF-60DSi

Indications for Use:

(Per 21 CFR 801.109)

aleations for USC.
DIGITAL FUNDUS CAMERA CF-60DSi is intended to be used for taking digital images of retina of human eye with a mydriatic.

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE) 1 OR Over-The-Counter Use Prescription Use

(Optional Format 1-2-96)

Evelyn K. Been

Division Siar Division of Ophthalmic Ear. Nose and Throat 0

510(k) Number K041546

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.