The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.

Device Description

The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a very small diameter of typically 1.5-3mm, Fiber light guides (single or bundles) transmit the light to the application such as headlights, endoscopes or other lighted tools.

AI/ML Overview

Based on the provided text, the device described is a "Xenon/Metal halide light source with fiber and headlight" (PS series) intended as an "AC-powered dental operating light." The document explicitly states:

"No performance data is required for this Class I device nor requested by FDA (ODE)."

Therefore, a detailed study proving the device meets specific acceptance criteria, as one might find for a more complex medical device, was not necessary or provided in this 510(k) submission. The submission primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.

Here's an breakdown based on your requested information, acknowledging the limitations due to the device's classification:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Functional Equivalence to Predicate Devices	The device is similar in use, design, and function to predicate devices from Isolux and Cogent (WelchAllyn).	This is the primary "acceptance criterion" for a 510(k) submission for a Class I device: demonstrating substantial equivalence to already legally marketed devices.
Illumination of Oral Structures and Operating Areas	Produces white light similar to sunlight. Optical components (mirrors, lenses, filters, coatings) are designed not to change the color temperature. Uses an extra short arc lamp for improved focusing of light into small fibers.	This describes the functional output of the device relative to its intended use, rather than a quantifiable performance metric against a set target.
Safety Standards Compliance	Fully meets IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, UL2601-1, CAN/CSA-C22.2 No. 601-1-M90, 47 CFR Ch.1 Part 15 (FCC), and IEC 60601-2-41 (regarding UV measurements).	Compliance with these international and national safety standards is a critical acceptance criterion for any medical device.

Study Details (or lack thereof)

Since "No performance data is required" for this Class I device, the following points are largely not applicable or indicate that a specific "study" as you might define it for a complex AI/diagnostic device was not performed.

Sample size used for the test set and the data provenance: Not applicable. No performance data was required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance data was required.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance data was required.
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: Not applicable. This device is a light source, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light source, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance data as it was not required.
The sample size for the training set: Not applicable. This device is a light source, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of the "Proof"

The "proof" that this device meets its "acceptance criteria" (which in this case are primarily substantial equivalence and safety compliance) is demonstrated through:

Comparison to Predicate Devices: The submission argues that the PS series light source is "similar in use, design and function" to several legally marketed predicate devices (Cogent/WelchAllyn Solartec Source ST270, Micro Link endoscopic fiber cable; Isolux America 1300 XSBP, 1125 XSB, Fiber optic surgical headlight, fiberoptic cable).
Adherence to Safety Standards: The document lists a comprehensive set of international and national safety standards that the device "fully meets." This is a critical component for FDA clearance, especially for devices where extensive performance testing might not be mandated.
Technological Description: The detailed description of how the device produces and channels light (e.g., short arc lamps, optical components, improved focusing into small fibers) serves to explain how it achieves its intended illumination function, and implicitly, how it is equivalent or even potentially an improvement in focusing effectiveness compared to older technologies (though this isn't framed as a strict performance claim with quantitative data).

In essence, for this Class I device, the regulatory pathway did not require the type of extensive performance study you've outlined for AI or diagnostic devices. The acceptance criteria were primarily met through demonstrating safety compliance and substantial equivalence to established predicate devices.

Summary

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FEB 1 2 2007

113

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b –

510(k) Summary of Safety and Effectiveness

Submitter

Photonic Optische Geräte GesmbH & CoKG Seeböckgasse 59 A-1160 Vienna, Austria Mr. Dieter Feger (GM) phone: +43(1)4865691-0 prepared: 13th March 2006

Device Submitted

Xenon/Metal halide light source with fiber and headlight

Proprietary Name

PS series

Common Name

Light source

Predicate Devices

Applicant	Predicate Device	510(k)	class, code, 21CFR
Cogent/WelchAllyn	Solartec Source ST270(CL300)	K983714	II, FFS, 876.1500
Cogent/WelchAllyn	Micro Link endoscopicfiber cable	K001698	II, FFS&KOD 876.1500
Isolux America	1300 XSBP	K022384	II, HBI&FST, 878.4580
Isolux America	1125 XSB	K052979	II, HET, 884.1720
Isolux America	Fiber optic surgicalheadlight	K991572	II, HBI, 878.4580I, EAZ, 872.4630
Isolux America	fiberoptic cable	K991208	II, FST, 878.4580
Isolux America	fiberoptic cable	K991208	II, HBI, 878.4580

Device Description

Intended Use

The AC-powered dental operating light, which can be attached via optical fibers to a headlight, is a device intended to illuminate oral structures and operating areas. The device is intended for Prescription Use only!

Technological Characteristics Similarities

The light sources PS series with fibers and headlights are similar in use, design and function to those from Isolux and Cogent (WelchAllyn).

Performance Data

No performance data is required for this Class I device nor requested by FDA (ODE).

Safety

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The device is designed for and fully meets following international safety standards:

· IEC 60601-1:1988 +A1:1991 +A2:1995
· IEC 60601-1-2:2001
· IEC 60601-2-18:1996 +A1:2000
UL2601-1:1997 .
· CAN/CSA-C22.2 No. 601-1-M90
· 47 CFR Ch.1 Part 15 (FCC)
· IEC 60601-2-41:2000 (in accordance to UV measurements)

Effectiveness

Metal halide or xenon arc lamps produce white light similar to sunlight. All light transmitting elements such as mirrors, lenses, filters and coatings are determined not to change the color temperature of the system.

This device uses an extra short arc lamp, which improves the effectiveness of focusing the light with the help of optics into a small fiber (single or bundle) with diameters typically between 1-3mm. Other commercial equipment uses fiber bundles with diameter of typically 4-6mm to transmit the same light flux.

Conclusion

The technological differences to the predicate devices do not affect the safety or efficacy of the sumbitted devices, therefore leads to the conclusion, that the cold light series PS including fibers and headlights are substantial equivalent to the Predicate Devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Photonic Optische Geräte GmbH & CoKG C/O Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Incorporated 1775 Old Hywy 8 NW New Brighton, Minnesota 55112-1891

FEB 1 2 2007

Re: K070287

Trade/Device Name: PS Series with Fiber Light Guide and Headlight Regulation Number: 872.4630 Regulation Name: Dental Operating Light Regulatory Class: I Product Code: EBA, EAZ, EAY Dated: January 23, 2007 Received: January 29, 2007

Dear Mr. Preiss:

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.

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Page 2 -Mr. Preiss

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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clars

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: PS series with fiber light guide and headlight

Indications For Use:

The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunson

Division of Gastroenterology
Beth Israel Deaconess Medical Hospital

670282

Page 1 of 1

Regulation Number and Section

§ 872.4630 Dental operating light.

(a)
Identification. A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.(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 § 872.9.