CF 1 is an improved model of CF-60DSi. Canon EOS Digital Camera is mounted with CF-1, can be viewed immediately, making procedures more efficient vaniera hand different applications, such as telemedicine and electronic filing. CF-1's intended use is the same as that of CF-60DSi. However, the differences in design are as follows: CF-1 can take images in three modes, such as COLOR, RED FREE, and FLOU. CF-60DSi can take images in four modes, such as COLOR, RED FREE, FLOU and ICG. ICG digital camera cannot be attached to CF-1. CF-1 has 2 variable powers (50//43 degree), where 43 degree is digital magnification. CF-60DSi has 2 optical variable powers (60//40 degree). CF-1 is equivalent to CF-60DSi in the following respect: The optical components and alignment and the mechanical structures of the CF-1 arc almost same as the CF 60DSi.

AI/ML Overview

The provided document is a 510(k) summary for the Canon Digital Retinal Camera CF-1. It primarily focuses on demonstrating substantial equivalence to a predicate device (Canon CF-60DSi) rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is not explicitly available in this document.

However, based on the information provided, here's an attempt to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not define explicit "acceptance criteria" as separate measurable thresholds. Instead, it demonstrates "substantial equivalence" by comparing the proposed device (CF-1) to the predicate device (CF-60DSi) across various technical specifications and intended use. The "reported device performance" is implicitly that it performs comparably to the predicate.

Feature / Criterion (Implicitly "Substantially Equivalent" to Predicate)	Predicate Device (CF-60DSi) Performance	Proposed Device (CF-1) Performance	Notes / Performance Claim
Intended Use	Taking digital images of retina of human eye with a mydriatic.	Taking digital images of retina of human eye with a mydriatic.	Same
Angular Field of View	60/40 degree	50/43 degree (digital magnification)	Difference noted, but deemed equivalent for intended use.
Min. diameter of pupil required	Not specified for predicate	φ5.5mm	Specified for CF-1, implied to be acceptable.
Working Distance (WD)	Not specified for predicate	45mm	Specified for CF-1, implied to be acceptable.
Focusing	Not specified for predicate	By aligning the split lines	Specified for CF-1, implied to be acceptable.
External Dimensions	Not specified for predicate	W320×D560×H565mm (Main unit), W225×D380×H485mm (Power control unit)	Specified for CF-1, implied to be acceptable.
Weight	Not specified for predicate	Approx. 27kg (Main unit), Approx. 27kg (Power control unit)	Specified for CF-1, implied to be acceptable.
Energy Consumed	1000VA	350VA	Lower consumption for CF-1 – an improvement.
Target Population	Ophthalmologist	Ophthalmologist	Same
Physical Safety & Compliance with Standards	UL60601-1	UL60601-1	Same
Biocompatibility	Not Applicable	Not Applicable	Same

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe an independent test set or any clinical study involving patient data to demonstrate performance. The comparison is based on technical specifications and design similarities. This is a 510(k) submission focused on substantial equivalence to a legally marketed predicate device, often relying on engineering and performance testing rather than clinical trials for devices of this type.

Sample Size for Test Set: Not applicable / Not mentioned.
Data Provenance: Not applicable / Not mentioned. (No clinical data presented).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no independent test set or clinical study demonstrating diagnostic performance is described, there's no mention of experts establishing ground truth for such a test set. The evaluation is primarily technical.

Number of Experts: Not applicable / Not mentioned.
Qualifications of Experts: Not applicable / Not mentioned.

4. Adjudication Method for the Test Set

As there is no clinical test set described, there is no mention of an adjudication method.

Adjudication method: Not applicable / Not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. The submission is about the equivalence of an ophthalmic camera, not an AI diagnostic algorithm or a device that impacts reader performance.

MRMC Study: No.
Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is an ophthalmic camera, which is a physical imaging device, not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant or described.

Standalone Performance: Not applicable.

7. The Type of Ground Truth Used

Given the nature of the device (an ophthalmic camera) and the 510(k) submission's focus on substantial equivalence, the "ground truth" implicitly relates to the accuracy and quality of the images produced compared to the predicate device, as well as adherence to safety standards. There is no mention of pathology, expert consensus on disease, or outcomes data.

Type of Ground Truth: Primarily engineering specifications, performance characteristics (e.g., image resolution, field of view, pupil requirements), and safety standards compliance.

8. The Sample Size for the Training Set

This document describes a medical device (an ophthalmic camera), not an AI/ML algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable.

Sample size for training set: Not applicable / Not mentioned.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned, this question is not applicable.

How ground truth for training set was established: Not applicable / Not mentioned.

Summary of Device and its Claim:

The Canon CF-1 Digital Retinal Camera is presented as a new model substantially equivalent to the predicate Canon CF-60DSi. The primary evidence for this claim rests on:

Same Intended Use: Both devices are for taking digital images of the human retina with a mydriatic.
Similar Optical and Mechanical Components: The CF-1's optical components, alignment, and mechanical structures are "almost same" as the CF-60DSi.
Compliance with Same Safety Standards: Both adhere to UL60601-1.
Technical Comparison Table: Highlighting similarities in many specifications and noting differences (like field of view and operating modes) that do not preclude substantial equivalence for the stated intended use. Notably, the CF-1 has a lower energy consumption (350VA vs 1000VA).

The submission argues that despite some differences (e.g., 3 imaging modes vs. 4 for the predicate, different variable powers), the CF-1 retains the fundamental features and performance necessary to achieve its intended use safely and effectively, comparable to the predicate device. It does not contain information about clinical studies or performance studies as one might expect for a diagnostic AI device.

Summary

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Appendix G: 510(k) Summary 510(k) Summary

October 11, 200

Prepared:

October 11, 2006

Submitter:

Company Name: Company Address:

Contact Person: Phone Number Fax Number:

Proposed Device:

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

Canon USA, Inc. (U.S. agent for Canon Inc.) One Canon Plaza Lake Success, NY 11042 Ms. Sheila Driscoll (516) 328-5602 (516) 328-5169

New Model Canon Inc. Canon CF-1 86HKI, Ophthalmic cameras Class II 063717 To be assigned
Predicate Device:

Manufacturer: Trade Name: Model Name: Classification Name Regulatory Class: FDA 510(k) #

Canon Inc. Canon CF-60DS! 86HKI, Ophthalmic cameras Class II K041546

Intended Use:

CF-1 is intended to be used for taking digital images of retina of human eye with a mydriatic.

Description Of Device: CF 1 is an improved model of CF-60DSi. Canon EOS Digital Camera is mounted with CF-1, can be viewed immediately, making procedures more efficient vaniera hand different applications, such as telemedicine and electronic filing.

CF-1's intended use is the same as that of CF-60DSi. However, the differences in design are as follows:

CF-1 can take images in three modes, such as COLOR, RED FREE, and FLOU .
CF-60DSi can take images in four modes, such as COLOR, RED FREE, FLOU and ICG. t
ICG digital camera cannot be attached to CF-1. .
CF-1 has 2 variable powers (50//43 degree), where 43 degree is digital magnification. . CF-60DSi has 2 optical variable powers (60//40 degree).

CF-1 is equivalent to CF-60DSi in the following respect:

The optical components and alignment and the mechanical structures of the CF-1 arc . almost same as the CF 60DSi. Picase refer to the CF 1 comparison table provided in this section.
JAN 2 3 2007

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Appendix G: 510(k) Summary

・・ ".

. .

ﺳ

Table of Comparison

			CF-60DSi	CF-1
FDA 510K #			K041546	Proposed Device
PROFORMANCE	Angular field of view		60/40 degree	50/43 degree (digital magnification)
	Actual image size			φ29×22 mm (on sensor array)φ7.5×5.7 (Type 1:on sensor array)
	Min. diameter of pupilrequired			φ5.5mm
	Working distance(WD)			45mm
	Focusing			By aligning the split lines
	Eye fixation lamp			External
	Filter set			Automatic/Manual
	Light source forphotography			Max. 300WS
	Image unit			EOS Digital CameraICG digital camera (with Adapter)
		Working rangeVerticalForward and backRight and leftChin rest (vertically)		38mm70mm120mm65mm
	Panning			30 degree, right or left
	External dimensionsMain unitPower control unit			W320×D560×H565mmW225×D380×H485mm
	Weight	Main unitPower control unit		Approx.27kgApprox.27kg
Intended use			Taking digital images of retina ofhuman eye with a mydriatic	Same
Energy		used	1000VA	350VA
delivered			Not Applicable	Same
Target population			Ophthalmologist	Same
Physical safety			UL60601-1	Same
Compliance with standards			UL60601-1	Same
Biocompatibility			Not Applicable	Same
Labeling			Printed model name and electrical ratings are changed."Rx Only" addedto and EMC reference removed from CF-1 rating label.

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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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The logo is simple, using a single color, and is designed to be easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2007

Canon USA, Inc. c/o Jeffrey D. Rongero Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747

Re: K063717

Trade/Device Name: Canon Digital Retinal Camera CF-1 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: January 9, 2007 Received: January 10, 2007

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 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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,

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M.B. Egelman Si MD

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 Statement

063717

510(K)Number(if known): -

Device Name: CF-1

Indications for Use:

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

. .

Prescription Use (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)

Dexider

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

t Devises

1/17/2007

Page 1

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.