Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.

Device Description

The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement of retinal blood flow.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. However, it does highlight that a published clinical study was included to support a claim of substantial equivalence to a predicate device.

Based on the available information, here's an attempt to answer your questions, with significant limitations due to the lack of explicit detail:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide a table of performance metrics against such criteria. The closest information is a comparison between the proposed device (Canon Laser Blood Flowmeter CLBF Model 100) and its predicate device (Heidelberg Retina Flowmeter). This comparison focuses on technical specifications and intended use rather than specific a priori acceptance criteria for performance.

Category	Canon Laser Blood Flowmeter CLBF Model 100 (Proposed Device)	Heidelberg Retina Flowmeter (Predicate Device)
Intended Use	Fundus observation with retinal blood flow measurement. To help doctors' reading of retinal images.	Laser scanning ophthalmoscope. (Similar intended use implied by substantial equivalence)
Velocity Measurement	Given in a real dimension (velocity: [mm/sec], flow rate: [ul/min]). Numerically: velocity, flow rate, vessel diameter. Graphically: time variation of velocity, flow rate.	Given as relative value. Numerically: velocity, flow, blood volume. Graphically: perfusion map of retina, velocity/flow/volume.
Measurement Duration	2 sec for data acquisition	2 sec
Measurement Laser	675 nm / max. 300uW (usually 200uW) laser diode	785 nm / 100uW laser diode
Fundus Observation	30 degrees (through optical finder / on PC monitor (optional))	max. 20x 20 (displayed on PC monitor) (The unit is unclear, likely degrees or square millimeters)
Diopter Compensation	-10 - +10 Diopter or more	-12 - +12 Diopter
Principle	Laser Doppler	Laser Doppler
Physical Safety	Limit exposure to laser light. Complies with UL 544, IEC 825 (pending 510(k))	Unknown (predicate device K943955)

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

The document mentions "A published clinical study was included to support a claim of substantial equivalence." However, it does not provide any details regarding:

The sample size of patients or images in this clinical study.
The country of origin of the data.
Whether the study was retrospective or prospective.

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 in the document. The nature of "blood flow information" provided by the device (velocity, flow rate, vessel diameter, time variation) suggests that ground truth would likely involve direct measurement techniques or other validated methods, rather than expert interpretation of images for initial validation. However, the document states the device "is intended to help doctor's reading of retinal images," implying some level of clinical assessment. Without details of the clinical study, the role of experts in establishing ground truth is unknown.

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

This information is not provided in the document.

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

The document does not indicate that an MRMC comparative effectiveness study was conducted. The claim of "substantial equivalence" is based on comparing the device's technical characteristics and intended use to a predicate device, and a "published clinical study" without further detail. There's no mention of AI assistance or human reader improvement.

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

The device is a "Canon Laser Blood Flowmeter CLBF Model 100" which performs "fundus observation with velocity measurement of retinal blood flow." Its output includes numerical values for velocity, flow rate, and vessel diameter, and graphical representations of time variation. The document states "The information of blood flow is also obtained by CLBF Model 100, and it is intended to help doctor's reading of retinal images." This implies the device provides quantitative measurements directly; it is not described as an "AI algorithm" in the modern sense that processes images for interpretation by humans. Therefore, the concept of "standalone performance" for an AI algorithm for diagnosis or detection doesn't directly apply here. The device itself is a measurement tool, and its "standalone performance" would relate to the accuracy and precision of its blood flow measurements. The document does not provide such detailed performance data.

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

The document does not explicitly state the type of ground truth. Given the nature of a blood flowmeter, ground truth for its measurements (velocity, flow rate) would most likely come from:

Direct physical measurements in controlled settings.
Comparison to other established, validated blood flow measurement techniques (if applicable for retinal vessels).
Clinical correlation with known physiological states or conditions related to blood flow (e.g., changes in flow in response to stimuli or in disease states).

The mention of a "published clinical study" suggests that some form of clinical validation or comparison was performed.

8. The sample size for the training set

The device is a measurement system (Laser Blood Flowmeter) and not described as an AI/machine learning model in the modern sense that requires a "training set" of data to learn from. Therefore, the concept of a training set sample size is not applicable to the information provided.

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

As there is no mention of a "training set" in the context of an AI/machine learning model, this question is not applicable based on the provided text.

Summary

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JUN 2 1 2000

K992606

510(k) Summary

Prepared:

July 15, 1999

Submitter:

Company Name: Canon USA, Inc. (U.S. designated agent for Canon Inc.) Company Address: One Canon Plaza Lake Success, NY 11042 Ken Shadoff, Senior Product Safety Engineer Contact Person: Phone Number: (516) 328-5602 Fax Number: (216) 328-2169

Proposed Device:

Reason For 510(k):	New Model
Manufacturer:	Canon Inc.
Trade Name:	Canon Laser Blood Flowmeter
Model Name:	CLBF Model 100
Classification Name:	HLI, Ophthalmoscope, AC-Powered
FDA 510(k) #:	To be assigned

Predicate Device:

Manufacturer:	Heidelberg Engineering Gmbh
Trade Name:	Heidelberg
Model Name:	Retina Flowmeter
Classification Name:	HLI, Ophthalmoscope, AC-Powered
FDA 510(k) #:	K943955

Description Of Device:

The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement of retinal blood flow.

Intended Use:

This device is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF Model 100, and it is intended to help doctor's reading of retinal images.

Technical Characteristics:

Please refer to the attached COMPARISON CHART.

Non-clinical Tests:

Software evaluation has been performed to support a claim of substantial equivalence. Documented non-clinical studies have been included to support a claim of substantial equivalence.

Clinical Tests:

A published clinical study was included to support a claim of substantial equivalence.

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mparison with the similar product of the other company (1/2)

Approved product : Heidelberg Engineering, Heidelberg Retina Flowmeter

July 15, 1999

	Manufacturerproduct name	Intended use	specification /function	fundusobservation	method	observation angle	illumination light	dioptercompensation rangefor examinee's eye	principle	velocitymeasurement	measurement laser	Product Name	specification /function	fundusobservation	measurementduration	measurement result	others	anatomical regions	target population	physical safety	compliance with standards	status of device	dimensions (W x D x H)	mass (kg)
Canon Inc.Canon Laser Blood FlowmeterCLBF model 100	Fundus observation withretinal blood flow measurementsimilar to conventional funduscamera with eye drop(through optical finder /on PC monitor (optional))			30	560 - 650 nmHalogen lamp	-10 - +10 Diopter or more		laser Doppler	675 nm / max. 300uW(usually 200uW)laser diode		Canon Laser Blood FlowmeterCLBF model 100			2 secfor data acquisition	given in a real dimensioni.e. velocity: [mm/sec],flow rate: [ul/min]	numerically: velocityflow ratevessel diametergraphically: time variation of velocity,flow rate	retina (one or both eyes)	general population	limit exposure to laser light	UL 544, IEC 825pending 510(k)		main unit: 320 x 560 x 620power control unit: 230 x 390 x 465	main unit: 30power control unit: 31
Heidelberg EngineeringHeidelberg Retina Flowmeter			laser scanning ophthalmoscopewith no eye drop(displayed on PC monitor)		max. 20x 20	670 nm / 100 uWlaser diode	-12 - +12 Diopter		laser Doppler	785 nm / 100uWlaser diode	Heidelberg Retina Flowmeter			2 sec	given as relative value	numerically: velocity,flow,blood volumegraphically: perfusion map of retinavelocity / flow / volume	same	same	same	unknownpost-amendment device, K943955		main unit: 300 x 360 x 530power control unit: 330 x 160 x 125control panel: 155 x 200 x 100	main unit: 13power control unit: 1control panel: 0.8

い!

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Comparison with the similar product of the other company (2/2)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2000

Ms. Sheila Driscoll Senior Product Safety Engineer Quality Management Department Canon U.S.A., Inc. One Canon Plaza Lake Success, NY 11042-1198

Re: K992606

Trade Name: Canon Laser Blood Flowmeter (CLBF) Model 100 Regulatory Class: II Product Code: 86 HLI Dated: April 19, 2000 Received: April 20, 2000

Dear Ms. Driscoll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sheila Driscoll

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Nancy C. Brogdon

Acting Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications Statement

--Page of

510(K)Number(if known):

K992606

Device Name:

CLBF MODEL 100

Indications for Use:

NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHERT F NEEDED

Concurrence of CDRH, Office of Device Evaluation(ODE) Over-The-Counter Use OR Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Denis L. Mᶜ Carthy

(Division Sign-Off) (Division of Ophthalmic D Kag2606 510(k) Number

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.