TruLight 5520 and 5320 light heads consist of 2 light modules containing LEDs which illuminate the area of a patient. The light heads are equipped with illuminated non-sterile hand grips. The light heads can be controlled on the control panel on the light head or on an optional wall control panel. Illuminance can be adjusted between 30 and 100%. Reducing the Illuminance does not change the color temperature of the light. The illuminance can also be adjusted to "endo" mode, which is 5%. The optional Adaptive Light Control (ALC) feature allows the lighting settings to be selectively adjusted to the working distance. The three settings for a working distance of approx. 0.8, 1.0 and 1.2 meters are selected on the control panel or on the wall control panel. The light head then selects the light setting suitable for this working distance. The Adaptive Light Control Plus (ALC+) offers automatic control of the light intensity. If the light head is moved during surgery, the motion detection function automatically measures the distance between the luminaire and the wound area. The light head then selects the light setting suitable for this working distance.

AI/ML Overview

The provided document is a 510(k) summary for a surgical light (TruLight 5520 and 5320). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria for an AI/CAD-like device. Therefore, much of the requested information regarding AI/CAD-specific study details (such as sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in this document.

However, I can extract information related to the device's performance characteristics and the general approach to demonstrating safety and effectiveness.

Here's the information as best as can be extracted from the provided text:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format. Instead, the document states that the new devices (TruLight 5520 and 5320) were tested to the same standards as the predicate devices and were found to have "similar or improved performance features" and are "not any less safe or effective." The key performance characteristic highlighted is illumination.

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with IEC 60601-1-2: 2007 (Electromagnetic Compatibility)	Complies with the requirements of IEC 60601-1-2: 2007.
Compliance with IEC 60825-1: 2007 (Laser Safety)	Tested to IEC 60825-1: 2007 (2nd Edition). Compares to similar devices with Class 2 lasers.
Illumination performance (similar/improved to predicate devices)	Tested to the same standards as predicate devices; found to have similar or improved performance features. Illuminance adjustable between 30% and 100%, and "endo" mode at 5%.
Safety and Effectiveness (not less than predicate devices)	Verified through testing to standards, risk analysis, and comparison to predicate devices, including those with Class 2 lasers.
Sterilization of reusable handle grips	withstands at least 350 steam sterilization cycles under specified conditions. The instructions are the same as for predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable/not provided. This document describes testing for a physical medical device (surgical light), not an algorithm or AI system that operates on a "test set" of data in the common sense for AI/CAD. The "testing" refers to physical product testing protocols and standard compliance.
Data Provenance: Not applicable/not provided for AI/CAD context. The testing is based on device performance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "Additional third-party experts" were involved in a risk analysis. A specific number is not provided.
Qualifications of Experts: Not specified beyond being "third-party experts" involved in a risk analysis.

4. Adjudication method for the test set:

Adjudication Method: Not applicable/not provided in the context of an AI/CAD test set. The document refers to a "thorough risk analysis by TRUMPF and additional third-party experts."

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:

MRMC Study: No, this is not an AI/CAD device. Therefore, no MRMC study, human-in-the-loop analysis, or effect size related to AI assistance is mentioned or relevant.

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

Standalone Performance: No, this is a physical medical device. This concept is not applicable.

7. The type of ground truth used:

Type of Ground Truth: The "ground truth" here is compliance with established international and national standards (e.g., IEC 60601-1-2 for EMC, IEC 60825-1 for laser safety) and inherent physical performance characteristics of the surgical light (e.g., illuminance, durability of sterilization). The core claim is "substantial equivalence" to predicate devices, meaning its performance, safety, and effectiveness are comparable.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/CAD device that undergoes a "training" process with a dataset.

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

Ground Truth for Training Set: Not applicable.

Summary

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K102758

E. 510 (k) Summarv

OCT 2 6 2010

Submitter:	TRUMPF Medizin Systemé GmbH + Co. KGBenzstraße 2682178 PuchheimGermany
Contact Person:	Lindsey RonnebergQuality Manager, TRUMPF Medical Systems, Inc.
	Phone: 843-416-1376Fax: 843-534-0206
Preparation Date:	September 8, 2010
Trade Name:	Surgical Light, TruLight
Common Name:	Surgical light, Ceiling Mounted
Classification Name:	Surgical Lamp
Product Code:	FSY
Device Relationships:	TRUMPF Medical Systems, Inc. distributes "Surgical lightCeiling Mounted, ILED" systems cleared under K061317.

with one to three arms per suspension. The devices are offered in a variety of combinations of the approved light heads. The light heads contain two to five modules each containing LEDs. The "ILED X" family of light heads will be transitioned to names involving "TruLight XXXX" over the next several years. The most complex of the ILED light heads is the ILED 5. The ILED 5 offers adjustable color temperature, dimming, focus, and shadow control.

TRUMPF Medical Systems, Inc. released the next versions of light heads including the TruLight 5500 and 5300 in 2009. These light heads in addition to the ILED 3 and ILED 5 are offered on the same suspension system as the "Surgical light, Ceiling Mounted, ILED". The TruLight 5500, 5300, and ILED 3 light heads are offered on a mobile stand as well. They are known as "Surgical Lamp Mobile". The mobile systems with the three light head options were cleared under K091246.

TRUMPF completed a letter to file stating that the TruLight 5500 and 5300 light heads offered on a ceiling mounted system (same mounting as the original ILED family light heads) did not require a 510K because there is no significant change from the cleared devices and there was no altering of the device's safety or effectiveness.

If Su

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TRUMPF Medical Systems, Inc. listed a surgical light Helion 501 and 701 cleared under K011693. This light was available with a laser focus feature. The laser was a Class 2 laser and it was an optional feature on the Helion light systems. This item is primarily listed as a predicated device due to its use of a laser for assistance with the focusing of the device (similar to the ALC+ feature).

Details of the predicated devices in comparison to the new devices are provided in pages 5 and 6 of this section.

Device Description:

The optional Adaptive Light Control (ALC) feature allows the lighting settings to be selectively adjusted to the working distance. The three settings for a working distance of approx. 0.8, 1.0 and 1.2 meters are selected on the control panel or on the wall control panel. The light head then selects the light setting suitable for this working distance.

The Adaptive Light Control Plus (ALC+) offers automatic control of the light intensity. If the light head is moved during surgery, the motion detection function automatically measures the distance between the luminaire and the wound area. The light head then selects the light setting suitable for this working distance.

The surgical light family is for illuminating an examination and Intended Use. surgical site on the patient in the clinic and doctor's office.

The TRUMPF surgical lights are intended to locally illuminate Indication for use: an operating or examination area of the patient's body with high intensity light.

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Predicate Device:	Light Surgical Ceiling Mounted, iLEDK# 061317
	Surgical Lamp, MobileK# 019246
	TRUMPF Surgical Lights, Models 501 and 701K# 011693
Substantial Equivalence:	Please see the Substantial Equivalence tables in page 5 and6 of this section to review the technical details andapplications of the predicated and new devices. The maindifference is identified here.
	The Main Difference:The difference from the predicated TL5500 and 5300 is theaddition of the Adaptive Light Control Plus (ALC+) option.Lighting systems prepared with the ALC+ option still have theoriginal ALC control system of the TruLight 5500 and 5300.The ALC+ system can be activated and deactivated by theuser pressing the left and right ALC symbols on their controlpanels. Therefore, the light can operate identically to thepredicated TruLight 5500 and 5300 light heads.
	Testing to the standards mentioned, risk analysis, andcomparison to devices with lasers similar to that of the ALC+have verified the new device is not any less safe or effectivethan the predicated devices.
Sterilization:	Reusable sterile handle grips are instructed to be sterilized bytraditional moist heat sterilization with the followinginstructions:
	Steam sterilization: The hand grips can withstand at least 350steam sterilization cycles without damage under the followingcriteria:- Steam sterilization at 121deg C, 1.3 bar 20 minutes, or- Steam sterilization at 270deg F, 41.84 psi, 4 minutes or- Steam sterilization at 134deg C, 2.3 bar, 4 minutes
	- Stand the hand grips vertically with the open side facingdownwards.
	- Do not exceed a sterilization temperature of 134deg C.
	- The hand grips must be sterilized individually in packagingsuitable for steam sterilization.
	Note: The sterilization instructions are the same for thepredicated devices, additional details can be found in eachOperator Manual.

。

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Electromagnetic Compatibility:

Performance Data:

The TruLight 5520 and 5530, same as their predicated devices, comply with the requirements of the IEC 60601-1-2: 2007 "General requirements for safety-Collateral standard: electromagnetic compatibility-Requirements and tests"

The TruLight 5520 and 5320 lighting systems have been tested to the same standards as the predicated devices and are found to have similar or improved performance features to the predicated devices.

The TruLight 5520 and 5320 lighting systems were reviewed with a thorough risk analysis by TRUMPF and additional third party experts to ensure the safety of our customers and their patients. TRUMPF Medizin Systeme GmbH + Co. KG. risk analysis reviewed possible mechanical, electronic, radiological, and handling failures associated to the TruLight and TruLight ALC+. Additional details are provided in tab G.

The device has been tested to IEC60825-1:2007 (2"® Edition). The laser compares to similar devices such as the Helion 501 and 701 lighting systems with Class 2 lasers.

These comparisons and test results have verified the new device is not any less safe or effective than the predicated devices.

Safe and Effective:

The TruLight 5520 and 5320 lighting systems have been tested to the same standards as the predicated devices. They have been subject to a thorough risk analysis. They have additionally been tested to IEC60825-1:2007 (2"d Edition). They compare to devices with Class 2 lasers similar to that of the ALC+, such as the Helion 501 and 701 lighting systems. These comparisons and test results have verified the new device is not any less safe or effective than the predicated devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wing. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

TRUMPF Medizin Systeme GmbH + Co. KG % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle, North Carolina 27709

OCT 2 6 2010

Re: K102758

Trade/Device Name: TruLight 5520 and TruLight 5320 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY, FQP, FTD, FSQ Dated: October 13, 2010 Received: October 14, 2010.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - Mr. Jeff D. Rongero

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 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 vours.

Sincerely yours,

F-n Nulh Nn

N. Melkersson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Surgical Light, Ceiling Mounted, TruLight

Indications for Use: The TRUMPF Surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nishar Oslan for mxm

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number_K102758

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.