TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 by TRUMPF MEDICAL SYSTEMS, INC.

Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates. An optional laser pilot is available on the Models 501, 701 and 1001. The laser pilot exactly marks the center of the light field. This makes it easier for the user to focus the light field with precision even if the operating area is very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of < 1 mW. The Model 1001 is also equipped with an anti-drift system. As soon as the light comes to a standstill, it will be fixed in position by built-in magnetic brakes. The brakes are automatically released whenever the handrail surrounding the light (or central handle) is touched.

AI/ML Overview

The provided text is a 510(k) Summary of Safety & Effectiveness for the Trumpf Surgical Light. It details the device's characteristics, intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or a study proving the device meets performance criteria in the way a clinical study for an AI/algorithm-driven device would.

This document describes a medical device (a surgical light) that is physically manufactured and tested against engineering standards rather than through clinical performance metrics like sensitivity, specificity, or reader agreement. Therefore, many of the requested points related to AI/algorithm performance and clinical studies are not applicable.

Here's why and what information can be extracted:

Acceptance Criteria & Reported Performance (Table): The document refers to conformance with engineering standards, not clinical performance metrics.
Sample Size (Test Set) & Data Provenance: Not applicable as this is a physical device tested against engineering standards.
Number of Experts & Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable.
Standalone Performance: Not applicable.
Type of Ground Truth: For a surgical light, "ground truth" would be established by physical measurements and adherence to specified engineering tolerances and safety standards.
Sample Size (Training Set): Not applicable.
Ground Truth for Training Set: Not applicable.

Here's the relevant information based on the document's content:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Standards Conformance)	Reported Device Performance (as stated in submission)
IEC 60601-2-41 Standard - Particular Requirements for the safety of surgical luminaries and luminaries for diagnosis, First edition 2000-02	"Test data... demonstrates that the lights perform as intended and are safe and effective."
IEC 601-1/EN 60601-1 Medical electronic equipment, Part 1, General requirements for safety	"Test data... demonstrates that the lights perform as intended and are safe and effective."
Software testing (for models with laser pilot and anti-drift system)	"[software testing] demonstrates that the lights perform as intended and are safe and effective."

Explanation for Other Points (Not Directly Applicable / Information Not Provided in the Text):

Sample Size Used for the Test Set and the Data Provenance: This document describes a physical medical device (surgical light). The "test set" in this context refers to the manufactured units that underwent testing for compliance with engineering standards. The sample size is not specified but would typically involve testing representative units from a production batch or specific prototypes. Data provenance (country, retrospective/prospective) is not relevant for this type of device testing from the provided text.
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts: Not applicable. Ground truth for a surgical light's performance against engineering standards is established by objective measurements and compliance with the standards, not expert consensus in the clinical sense.
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set: Not applicable. Testing against engineering standards involves objective measurement and verification, not adjudication by experts for discrepancies.
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 is a surgical light, not an AI or imaging diagnostic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have a standalone algorithm in the typical sense of AI/diagnostic software. The "software testing" mentioned for the laser pilot and anti-drift system would refer to functional verification of those integrated electronic components, not an algorithm for clinical interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance is established by the engineering standards themselves (IEC 60601-2-41, IEC 601-1/EN 60601-1) and objective measurements against the specifications outlined in those standards. This includes measures like light intensity, beam uniformity, heat output, electrical safety, and functional performance of features like the laser pilot.
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary of Safety & Effectiveness

Trumpf Medical Systems, Inc. Submitter 415 Jessen Lane Wando, SC 29492 Mr. William Apperson Contact President and CEO (843) 534-0606 Fax: (843) 534-0206 BAPP1024@aol.com May 7, 2001 Date Device Trade Name: Trumpf Surgical Light . Common Name: Surgical Light, Examination Light Classification: 21 CFR 878.4580 - Surgical Light - Class II ● Product Code FSY ● Drager Sola Surgical Light legally marketed under 510(k) premarket Predicate Device notification K984611. The Trumpf surgical lights are intended to locally illuminate an operating or Indications for Use examination area of the patient's body with high intensity light. Device Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, Description 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates.

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011693

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510(k) Summary of Safety & Effectiveness, Continued

An optional laser pilot is available on the Models 501, 701 and 1001. The Device laser pilot exactly marks the center of the light field. This makes it easier for Description, the user to focus the light field with precision even if the operating area is continued very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of < 1 mW. The Model 1001 is also equipped with an anti-drift system. As soon as the light comes to a standstill, it will be fixed in position by built-in magnetic brakes. The brakes are automatically released whenever the handrail surrounding the light (or central handle) is touched. The technological characteristics of the Trumpf Surgical Light are the same as Technological the predicate device, the Drager Sola Surgical Light. The physical Characteristics characteristics, performance specifications, materials, dimensions and all other characteristics of the Trumpf surgical lights are identical to the Sola surgical lights. Test Data Test data to support the conformance to: IEC 60601-2-41 Standard - Particular Requirements for the safety of . surgical luminaries and luminaries for diagnosis, First edition 2000-02 IEC 601-1/EN 60601-1 Medical electronic equipment, Part 1, General . requirements for safety, and software testing demonstrates that the lights perform as intended and are safe and effective. Based on the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that the Trumpf Surgical Light is substantially equivalent to the predicate device, the Drager Sola Surgical Light under the Federal Food, Drug and Cosmetic Act.

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Public Health Service

JUN 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trumpf Medical Systems, Inc. c/o Mr. Kent Donohue Senior Staff Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, North Carolina 27709

Re: K011693

Trade/Device Name: Trumpf Surgical Light Models 301, 501, 701 and 1001 Regulation Number: 878.4580 Regulatory Class: II Product Code: FSY Dated: May 30, 2001 Received: May 31, 2001

Dear Mr. Donohue:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kent Donohue

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothloate 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 and 11 you desire specific dains and on the devices), please contact the Office of Compliance at additionally 607.10 for in in the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsible free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Milkersen

elia M. Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: k 011613

Device Name: Trumpf Surgical Lights Models 301, 501, 701 and 1001

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use '/ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

fo. Much n Mill
(Division Sign Off)

Division of General, Restorative and Neurological Devices

510(k) Number K011693

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.