The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".

Device Description

The iLED surgical light mobile family is suitable for all types of surgical procedures. TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters. The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the iLED Surgical Family, Mobile device:

Important Note: The provided text is a 510(k) summary for a surgical light, not an AI/ML medical device. Therefore, many of the requested categories, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only) performance," "ground truth," and "training set sample size," are not applicable to this type of device and submission. The FDA 510(k) process for a device like a surgical light focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing against established standards and comparison of technical specifications.

Acceptance Criteria and Device Performance for TRUMPF iLED Surgical Family, Mobile

Since this is a conventional medical device (surgical lamp) and not an AI/ML-driven device, the "acceptance criteria" are implied by the performance characteristics demonstrated and compared to the predicate devices and general standards for surgical lights. The "study" here refers to the justification for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (from K091246 Summary)
Illumination Source:	LED light heads
Light Intensity:	High intensity illumination
Light Homogeneity:	Homogeneous light field
Shadow Reduction:	Shadow-free illumination
Heat Emission:	"Cold light" (minimal heat emission)
Mobility:	Mobile stand with base and 4 casters (plugs into outlet)
Mechanical Arm/Mounting:	Uses same spring arm as ceiling-mounted version; mounted to mobile stand
Electronics & Software:	Uses same electronics and software as ceiling-mounted iLED family
Safety & Effectiveness:	No significant issues that raise safety and effectiveness concerns compared to predicate.
Intended Use:	Illuminating examination and surgical site on patient in clinic and doctor's office.

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

Test Set Sample Size: Not applicable in the context of an AI/ML device where a "test set" implies specific patient data. For this surgical light, performance is demonstrated through technical specifications, testing against industry standards, and comparison to predicate devices. There isn't a "test set" of patient cases.
Data Provenance: Not applicable in the AI/ML sense. The performance characteristics of the device were assessed through engineering design, component testing, and comparison of technical specifications, implied to be conducted by the manufacturer, TRUMPF Medizin Systeme GmbH + Co. KG, Germany.

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

Number of Experts/Qualifications: Not applicable. Ground truth, in the AI/ML context, refers to expert labeling of data. For a surgical light, the "ground truth" of its performance is derived from physical measurements against established engineering and medical device standards. No external experts are mentioned for "ground truth labeling."

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

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: Not applicable. This device is a surgical lamp, not an AI-assisted diagnostic or therapeutic tool that enhances human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This is not an AI algorithm. Its performance is inherent to its physical design and functionality.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the AI/ML data labeling sense. The "ground truth" for a surgical light's performance would be objective measurements against established international and national standards for surgical illumination, such as those related to illuminance, color temperature, shadow dilution, and radiated heat, as well as verification of mechanical and electrical safety. The submission implies these standards were met, and the design is substantially equivalent to existing approved devices.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary of the Study Proving Substantial Equivalence (Not "Meets Acceptance Criteria" in the AI/ML Sense):

The "study" presented in K091246 is a substantial equivalence determination based on a comparison to predicate devices, rather than a clinical trial or performance study against specific acceptance criteria for a novel AI algorithm.

Device: iLED Surgical Family, Mobile
Predicate Device 1: iLED (lamp heads are identical) K# 061317 (This refers to the ceiling-mounted version of the iLED surgical light family).
Predicate Device 2: Trumpf surgical light models 301, 501, 701, and 1001 (mobile stand option was included) K# 011693.

Key Arguments for Substantial Equivalence:

Identical Lamp Heads: The iLED surgical light mobile family uses identical LED light heads to the previously cleared ceiling-mounted iLED surgical light system (K#061317). This implies that the core illumination technology meets established performance and safety characteristics.
Identical Electronics and Software: The device uses the same electronics and software as the ceiling-mounted iLED family. This suggests consistent control and performance characteristics.
Same Spring Arm: The mobile version uses the same spring arm as the ceiling-mounted version, indicating similar articulation and positioning capabilities.
Main Difference - Mounting: The primary difference is the method of mounting (to a mobile stand with a base and casters) making it mobile, a feature already present in a predicate device (K#011693).
No New Safety/Effectiveness Concerns: The submitter asserts, and the FDA agrees by clearning the device, that "There is no difference between the devices that raise any significant issues of safety and effectiveness."

In essence, the "study" for this device is a regulatory submission demonstrating that its design, performance characteristics, and intended use are similar enough to existing, legally marketed surgical lights that it does not raise new questions of safety or effectiveness.

Summary

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KC091246

5. 510 (k) Summary

SEP 2 8 2009

Submitter: TRUMPF Medizin Systeme GmbH + Co. KG Benzstraße 26 82178 Puchheim Germany

Contact Person:

Michae! Bartesch product manager

April 16, 2009

Phone: ++49 89 80 90 7 - 0 Fax: ++49 89 80 90 7 - 20

Preparation Date:

Trade Name: iLED Surgical Family, Mobile

Surgical lamp, Mobile Common Name:

Classification Name: Surgical Lamp

Device Description:

The iLED surgical light mobile family is suitable for all types of surgical procedures.

TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters.

The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.

PAGE 10 of 13 PAGES

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Intended Use of the Device

Indication for use:

Predicate Device:

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

The iLED surgical lamps illuminate the surgical site with a high intensity, homogenous light.

iLED (lamp heads are identical) K# 061317

Trumpf surgical light models 301, 501, 701, and 1001 (mobile stand option was included) K # 011693

Substantial Equivalence:

Main Difference:

Substantial Equivalence: The iLED surgical light mobile family had identical lamp heads as the iLED surgical light ceiling mounted versions. The iLED surgical light mobile family uses the same spring arm as the ceiling mounted version and same electronics as the ceiling mounted version. The mobile family is substantially equivalent to the mobile stand approved in K #011693 and other mobile surgical light systems. There is no difference between the devices that raise any significant issues of safety and effectiveness.

The method of mounting the spring arm is the main difference from the iLED surqical light ceiling mounted, the unit is made mobile. The spring arm for the unit is mounted to a mobile stand with a base and 4 casters and plugs into an outlet. The main difference from the mobiles included in K # 011693 is the light heads, which are LED light heads (identical to those sold as ceiling mounted per K#061317).

PAGE 11 of 13 PAGES

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird-like figure with three stylized wing or feather shapes.

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

TRUMPF Medizin Systeme GmbH + Co. KG % TRUMPF Medical Systems, Inc. Ms. Lindsey Hengel 415 Jessen Lane Charleston, South Carolina 29492

Re: K091246

Trade/Device Name: Surgical Lamp Mobile Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSS Dated: September 15, 2009 Received: September 16, 2009

SEP 2 8 2009

Dear Ms. Hengel:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Lindsey Hengel

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/CDRH0ffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

FOR

Sincerely vours.

Klaus L. Beyer

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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Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known): K091246

Device Name: Surgical Lamp Mobile

Indications for Use: The surgical light family is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold light".

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
M. FOR M. MELKERSON

(Division Sign-Off), Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091246

Page 1 of 1

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.