The OSRAM ITOS O-03100 is intended to provide illumination of the ear canal and tympanic membrane for observation. It is intended for over-the-counter (OTC) use.

Device Description

The OSRAM ITOS O-03100 is an optional accessory lamp for use in compatible Welch Allyn otoscopes (Models 20000, 20200, 21700, 25020). The OSRAM ITOS O-03100 utilizes light emitting diode (LED) technology.

AI/ML Overview

Here's an analysis of the provided text regarding the OSRAM ITOS O-03100, focusing on acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device. It primarily details general information, indications for use, device description, and performance data from bench tests and some limited clinical evaluation. It is not a detailed report of a clinical trial designed to establish specific performance metrics against pre-defined acceptance criteria in the way one might expect for a novel high-risk device. Therefore, some requested information may not be explicitly present or may be inferred from the context of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for an accessory lamp that demonstrates substantial equivalence, the "acceptance criteria" are not framed as quantitative statistical thresholds for sensitivity, specificity, or similar clinical performance metrics. Instead, they are related to equivalence with the predicate device and safety standards. The "device performance" is presented as evidence of this equivalence and safety compliance.

Acceptance Criterion (Inferred from Substantial Equivalence Goal)	Reported Device Performance
Equivalent Intended Use and Indications for Use	OSRAM ITOS O-03100 has the same intended use and indications for use as the predicate (illumination of ear canal and tympanic membrane for observation, OTC use).
Equivalent Performance (Bench Testing Critical Parameters)	Bench testing results for key performance parameters demonstrated equivalent performance with respect to parameters critical to safety and effectiveness compared to the predicate otoscope lamp. (Specific parameters are not enumerated, but the broad claim of equivalence is made.)
Durability (Robustness to Real-world Applications)	Drop tests (lamp alone, otoscope system) and a pull test of the outer sleeve from the heat sink. Results substantiate that the device is robust to real-world applications. (Specific quantitative thresholds for "robust" are not provided, only that the tests were performed and results were satisfactory).
Photobiological Safety (Blue Light Hazard)	Evaluated against IEC 62471:2006-07 Ed. 1. Result: "EXEMPT group" for the ITOS O-03100 LED. (Meaning it poses no photobiological hazard under standard use conditions).
Light Hazard Protection (Inadvertent Ophthalmoscope Use)	Tested in ophthalmoscope heads according to ISO 15004-2. Result: OSRAM ITOS O-03100 LED lamp classified as "group 2" per ISO 15004-2. Measured values in all 3 ophthalmoscope heads were below allowable limits for weighted corneal/lenticular UV radiation, unweighted corneal/lenticular UV radiation, unweighted corneal/lenticular IR radiation, and weighted retinal visible/IR radiation thermal radiance. Time-integrated radiance resulted in exposure time limits of ~3 minutes (for 11710 and 11720 heads) and 9 minutes (for 11810 head). This led to a cautionary label.
Clinical Equivalence (No Misdiagnoses due to Light)	A clinical study found "no clinically meaningful differences in clinicians' perceptions of the topography of the ear drum and ear canal or in the diagnoses obtained" with the ITOS O-03100 LED lamp versus the predicate tungsten-halogen lamp. This indicates effectiveness and lack of negative impact on diagnosis. (Specific quantitative acceptance criteria for "clinically meaningful differences" are not provided).
Product Integrity (Shipping)	OSRAM Sylvania will conduct testing to ASTM 4169 (Performance Testing of Shipping Containers and Systems) according to Assurance Level I and Criterion 1 and will assure conformance prior to commercial distribution. (This is a future commitment, not a past result at the time of submission, but indicates the benchmark for acceptance).

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

The provided document describes a "clinical study," which serves as the "test set" for assessing clinical equivalence.

Sample Size: Not explicitly stated. The text only mentions "clinicians" and "diagnoses." It does not provide the number of patients, cases, or clinicians involved in the study.
Data Provenance: Not explicitly stated whether it was retrospective or prospective, nor the country of origin. However, given that it's a study for a 510(k) submission to the FDA, it is generally assumed to be a prospective study.

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

This information is not provided in the text.
The clinical study focused on "clinicians' perceptions" and "diagnoses obtained," suggesting that the clinicians themselves were the "experts" whose judgment was being compared between the two lamps. There is no mention of a separate group of experts establishing an independent "ground truth" for the cases presented in this specific clinical study.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated.
Since the study compared "clinicians' perceptions" and "diagnoses obtained" with two different lamps, it likely involved clinicians evaluating cases. Without further details, it's impossible to determine if there was a consensus or a majority-rule adjudication method among multiple clinicians for each case, or if individual clinician evaluations were merely compared.

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

This was not a typical MRMC comparative effectiveness study in the sense of measuring improvement in diagnostic accuracy with AI assistance. Instead, it was a comparative study between a new technology (LED lamp) and a predicate technology (halogen lamp) to determine if the new technology introduced no clinically meaningful differences in diagnostic performance.

The text states: "There were no clinically meaningful differences in clinicians' perceptions of the topography of the ear drum and ear canal or in the diagnoses obtained with the ITOS O -03100 lamp and the predicate tungsten-halogen lamp."
Effect Size: No quantitative effect size (e.g., how much human readers improve with AI vs. without AI) is provided as this was not the purpose of the study. The study aimed to show non-inferiority or equivalence rather than improvement.

6. If a Standalone (Algorithm Only) Performance Study Was Done

This question is not applicable as the device is an accessory lamp, not an algorithm or an AI system itself. Its performance is tied directly to human use.

7. The Type of Ground Truth Used

For the clinical study:

The "ground truth" was implicitly established by the clinicians' "diagnoses obtained" and "perceptions" while using either lamp. The study aimed to show that the use of the new LED lamp did not alter these diagnoses or perceptions in a clinically meaningful way compared to the predicate. There's no mention of an independent, objective "pathology" or "outcomes data" ground truth against which the clinicians' diagnoses were compared.

8. The Sample Size for the Training Set

This question is not applicable. The device is an accessory lamp and does not involve AI/ML requiring a training set.

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

This question is not applicable as there is no training set for this device.

Summary

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K110326

OCT 2 7 2011

Image /page/0/Picture/2 description: The image shows the logo for OSRAM SYLVANIA. The words "OSRAM" and "SYLVANIA" are stacked on top of each other on the left side of the logo. To the right of the words is a circle with a lightbulb inside of it. The word "SYLVANIA" is written inside the lightbulb.

SP/Display Optic SSL

510(k) Summary

ﺔ

General Information

Date of Summary Preparation:

Name and Address of Manufacturer:

Company Contact Person:

Application Contact Person:

October 21, 2011

OSRAM SYLVANIA, Inc. 129 Portsmouth Avenue Exeter, New Hampshire, 03833

Jack Burwick Product Marketing Manager, NAFTA SSL Telephone: 603-778-4555 Fax: 603-778-0674

Marie A. Schroeder, MS, PT Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 Telephone: (301) 272-3286 Fax: (301) 272-0004

SRAM SYLVANIA Portsmouth Ava Exeter NH 03833 (603) 778-4555

ww.sylvania.com

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Trade Name:	OSRAM ITOS O-03100
Common Name:	Otoscope accessory lamp
Regulation Number:	21 CFR 874.4770
Classification Name:	Otoscope
Device Class:	Class I
Classification Panel:	Ear, Nose, and Throat
Product Code:	ERA
Predicate Device:	Welch Allyn Otoscope Diag. Model 20200K781029Welch Allyn OtoscopeModels 20000, 21700, 25020501(k) numbers unknown

Indications for Use:

The OSRAM ITOS O-03100 is intended to provide illumination of the ear canal and tympanic membrane for observation.

It is intended for over-the-counter (OTC) use.

Device Description:

Performance Data:

Bench testing results for the key performance parameters were provided and demonstrated equivalent performance with respect to parameters critical to safety and effectiveness.

Durability tests performed included a drop test of the OSRAM ITOS 0-03100 lamp by itself, a drop test of the otoscope system (lamp, otoscope head and 3.5VDC battery handle), and a pull test of the outer sleeve from the heat sink. The results from these three durability tests substantiate that the OSRAM ITOS O-03100 LED lamp is robust to real-world applications with respect to durability.

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Prior to commercial distribution of the OSRAM ITOS O-03100, OSRAM Sylvania will conduct testing to the applicable sections of ASTM 4169 Performance Testing of Shipping Containers and Systems according to Assurance Level I and Criterion 1 to evaluate the product integrity and will assure conformance with Assurance Level I and Criterion 1 prior to commercial distribution.

Substantial Equivalence:

The OSRAM ITOS O-03100 (accessory otoscope lamp) and the predicate otoscope lamp have the same intended use and indications for use, i.e., they are intended to provide illumination of the ear canal and tympanic membrane for observation and both are intended for over-the-counter (OTC) use. While the OSRAM ITOS O-03100 utilizes a different fundamental technology, (LED technology) the new technological characteristics do not raise new types of safety or effectiveness questions. A comparison of the technological characteristics and bench testing results for the key performance parameters and durability demonstrated equivalent performance of the OSRAM ITOS O-03100 as compared to the predicate otoscope lamp with respect to parameters critical to safety and effectiveness.

OSRAM SYLVANIA followed IEC 62471:2006-07 Ed. 1 Photobiological Safety of Lamps and Lamp Systems for providing an optical radiation hazard evaluation (including blue light hazard exposure limits) resulting in an "EXEMPT group" for the ITOS O-03100 LED. In addition, the ITOS O-03100 was tested in ophthalmoscope heads in accordance to ISO 15004-2 Ophthalmic Instruments - Fundaments requirements and test methods- Part 2: Light hazard protection to determine risk of inadvertent use in an ophthalmoscope head. The resulting data show that the OSRAM ITOS 0-03100 LED lamp (found to be in "group 2" per ISO 15004-2 classification) measured in all 3 ophthalmoscope heads produced values that are below the allowable limits for weighted corneal and lenticular ultra violet radiation irradiance, unweighted corneal and lenticular ultra violet radiation irradiance, unweighted corneal and lenticular infrared radiation irradiance, and weighted retinal visible and infrared radiation thermal radiance. Additional testing completed in accordance with section 5.5.16 for weighted retinal time-integrated radiance resulted in an exposure time limit of approximately 3 minutes for ophthalmoscope heads 11710 and 11720. The exposure time limit for the 11810 ophthalmoscope head was 9 minutes. Package labeling includes a cautionary note "not for use in ophthalmoscope attachments."

A clinical study was conducted regarding potential misdiagnoses due to possible different light characteristics associated with the OSRAM ITOS O-03100 LED lamp as compared to the predicate halogen lamp. There were no clinically meaningful differences in clinicians' perceptions of the topography of the ear drum and ear canal or in the diagnoses obtained with the ITOS O -03100 lamp and the predicate tungsten-halogen lamp. Therefore, the ITOS O -03100 lamp and the predicate tungsten-halogen lamp are effective when used in Welch Allyn otoscope heads.

Therefore, the OSRAM ITOS 0-03100 is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

OCT 2 7 2011

Osram Sylvania, Inc. c/o Marie A. Schroeder, Principal Consultant, Quintiles Consulting 1801 Rockville Pik e, Suite 300 Rockville, MD 20852

Re: K110326

Trade/Device Name: OSRAM ITOS (Model O-3100) Regulation Number: 21 CFR 874.4770 Regulation Name: Otoscope Regulatory Class: Class I Product Code: ERA Dated: September 12, 2011 Received: September 13, 2011

Dear Ms. Schroeder:

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 markets 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 (Act 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 warranties . We reminde . CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device lo contract to contract mability

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 of class in (PMA)
found in the Gode of Fade of Forley of Decembers 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); medical device reporting (reporting of medical

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Page 2 - Marie A. Schroeder

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,

Evelyn. M. h.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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):_K110326

Device Name: _________________________________________________________________________________________________________________________________________________________________ OSRAM ITOS O-03100

Indications For Use:

The OSRAM ITOS O-3100 is intended to provide illumination of the ear canal and tympanic membrane for observation.

Prescription Use . (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rudy cRNP
(Division Sign-Off)

Page 1 of 1

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K110326 510(k) Number.

Regulation Number and Section

§ 874.4770 Otoscope.

(a)
Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.