The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

Device Description

The Keeler Wide Angle Ophthalmoscope is a hand held indirect monocular device for use by trained personnel for viewing the cornea and retina of a patient. The viewing path in conjunction with the large solid angle projection of the illumination path provides two angles of view which provides larger fields of view than attainable with a conventional direct ophthalmoscope. The viewing optical system composes of two objective lenses, relay components and eyepiece provide an erect, un-reversed image of the patients retina to the doctor. The illumination path of the instrument consists of a filament lamp, a condensing system, two full mirrors and one semi-reflector mirror. The illumination path is imaged iust below the viewing optics axis as they combine at the semi-reflector mirror. The condensing lenses image the lamp filament essentially onto the patient's cornea. The filament image at the corneal plane is small permitting an increase ease of entry into undilated pupil. Any reflections of the filament from the surface of the cornea are trapped on light stops, which are positioned within the viewing optics. This allows the practitioner to obtain reflex free images of the retina.

AI/ML Overview

The provided text describes a 510(k) summary for the Keeler Wide Angle Ophthalmoscope. This type of regulatory submission demonstrates substantial equivalence to a predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria, sample sizes, or ground truth establishment in the manner of AI/software devices. The document explicitly states: "The effectiveness of the Keeler Wide Angle Ophthalmoscope is the same as current monocular indirect ophthalmoscopes already on the market."

Therefore, the study described is not designed to meet specific acceptance criteria with quantifiable performance metrics such as sensitivity, specificity, or AUC against a defined ground truth, as would be typical for an AI/CADe device. Instead, the effectiveness is established by demonstrating equivalence in intended use and operating principles to existing predicate devices.

However, I can extract the information related to how "effectiveness" was assessed, even if it's not a quantitative study in the sense of AI performance evaluation.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated as Needs Assessment)	Reported Device Performance (Summary of Effectiveness)
Device to meet "all of the practitioner's needs"	"performs the needs of the documentation procedure in an equivalent or better manner of effectiveness."
Safety equivalent to or safer than existing devices	"as safe as or safer than existing similar devices already in the market place."
Performance equivalent to existing monocular indirect ophthalmoscopes	"Effectiveness... is the same as current monocular indirect ophthalmoscopes already on the market."

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly quantified. The document refers to "practicing physicians" participating in "assessments" to establish if the device met their needs.
- Data Provenance: Not specified, but implied to be from clinical use by practitioners. Retrospective or prospective is not mentioned, but "assessments" with "practicing physicians" suggests a prospective evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated as a specific number. The document mentions "the evaluating physicians," implying multiple individuals.
- Qualifications: "practicing physicians" who were "users of either the Keeler Ophthalmoscope or a competitor's model (all have the same intended use)." No specific experience levels (e.g., "radiologist with 10 years of experience") are provided.
Adjudication method for the test set:
- No formal adjudication method (like 2+1, 3+1) is described. The "assessments" by evaluating physicians led to a qualitative conclusion about meeting needs.
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:
- No MRMC study was conducted. This device is a manual ophthalmoscope, not an AI-assisted device, so this type of study is not applicable. The comparison was about the device's performance versus predicate devices, not human reader improvement with AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical instrument, not an algorithm. Its performance is inherently human-in-the-loop as it's operated by a physician.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The "ground truth" in this context was qualitative, based on the subjective assessment and feedback from "practicing physicians" regarding whether the device met their "needs" and performed equivalently or better than existing devices for "documentation procedure." It was not based on objective diagnostic criteria like pathology or outcomes data.
The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in the conventional sense for AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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NOV 2 6 2003

K032087

"510(k) SUMMARY" Summary of Safety and Effectiveness

Submitter's Name & Address:Keeler Instruments Inc. 456 Parkway Broomall, PA. 19008

Contact Person & Telephone: Eugene R. VanArsdale (610)-353-4350

Date Summary Prepared:	July 2, 2003
Device Name:	Classification Name - Indirect OphthalmoscopeCommon/Usual Name - OphthalmoscopeProprietary Name - Keeler Wide Angle Ophthalmoscope
Predicate Device:	Welch Allyn 11800 Ophthalmoscope

Device Description, Intended Use & Effectiveness:

The illumination path of the instrument consists of a filament lamp, a condensing system, two full mirrors and one semi-reflector mirror. The illumination path is imaged iust below the viewing optics axis as they combine at the semi-reflector mirror. The condensing lenses image the lamp filament essentially onto the patient's cornea. The filament image at the corneal plane is small permitting an increase ease of entry into undilated pupil.

Any reflections of the filament from the surface of the cornea are trapped on light stops, which are positioned within the viewing optics. This allows the practitioner to obtain reflex free images of the retina.

This instrument with it two larger field of views and increased ease of entry allows for a more thorough examination of the retina while minimizing the exam and exposure time to the patient. The effectiveness of the Keeler Wide Angle Ophthalmoscope is the same as current monocular indirect ophthalmoscopes already on the market.

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Technological Characteristics:

Criteria	Keeler Wide Angle Ophthalmoscope
	Model No: 1130-P-5004
Type:	Monocular Indirect
Power Source:	3.5 volts
Illumination:	Xenon lamp
Viewing Optics:	Glass
Image Position:	Right Side Up
Size:	190mmL x 120mmH, x 45mmW
Weight	300 grams
Date Introduced	2003

Safety:	An abundance of safety areas were investigated and reviewed from theRisk Analysis stage, right through the project to ensure that the KeelerWide Angle Ophthalmoscope is as safe as or safer than existing similardevices already in the market place. The specific safety areas consideredare as follows:
Toxicity -	Materials used are neither toxic nor known to create significant allergicreactions when used as intended by the manufacturer.
Electrical -	External test house approval to EN ISO 15004
Light -	Light output levels are consistent to similar devices in the field, UV andIR filtering complies with EN ISO-15004.
Corrosion -	Device is non-corrosive
Explosion -	Highly unlikely; manufactured of non-explosive materials. Uses approvedmedical grade power supplies already on the market.
Surface -Temperature	All surfaces have been evaluated for practitioner and patient contact.
Fire Hazard -	Probability extremely low. This system is illuminated by a xenon lamp,which draws a maximum of 2.6 watts of power.
Mechanical -	The instrument has been designed to ensure that the risk of physical injurywhen performing the intended function(s) has been reduced as much ispracticable.

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Product Risk Assessment to EN1441, Risk Analysis, Verification and Design validation were conducted on this device.

Summary of Effectiveness:

The determination of device effectiveness was co-coordinated in the following manner.

The Keeler Wide Angle Ophthalmoscope development teams conducted assessments of the device with practicing physicians in an effort to establish if the device met all of the practitioner's needs.

The evaluating physicians were also users of either the Keeler Ophthalmoscope or a competitor's model (all have the same intended use). The results of the assessments indicated that the Keeler Wide Angle Ophthalmoscope performs the needs of the documentation procedure in an equivalent or better manner of effectiveness.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is represented by a staff with two snakes entwined around it, topped with a set of three human profiles facing to the right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2003

Keeler Instruments Inc. % Mr. Eugene R. VanArsdale Marketing Manager 456 Parkway Broomall, PA 19008-4295

Re: K032087

Trade/Device Name: Keeler Wide Angle Ophthalmoscope Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLJ Dated: October 20, 2003 Received: October 21, 2003

Dear Mr. VanArsdale:

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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Page 2 - Mr. Eugene R. VanArsdale

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 (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 Manufacturers, 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. Palgi 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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Intended Use:

Applicant: Keeler Instruments Inc.

510(k) Number (if known): `K032087

Device Name: Keeler Wide Angle Ophthalmoscope

Indications for Use:

Prescription Use	V
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Callaway

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

K032087 510(k) Number _

1-1

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.