The Mach LED 2SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.

One LED-module consists of one white LED.

The light system can be added to the ceiling mounted suspension system supporting the horizontal arms and spring arms. The horizontal arms can be rotated horizontally with 360°, the spring arms can be rotated horizontally with 360° and moved vertically with 50° downwards and 45° upwards.

The light system is operated by a kevpad on the lamp head or, by special request of the customer, by a keypad on the wall.

The surgical light Mach LED 2SC will be marketed with merging of light fields and light intensity control. Color temperature adjustment will not be available.

Available accessories for the Mach LED 2SC lighting systems are as follows:

Camera module .
Remote control of camera module .
Remote control with network interface for camera module .
Single monitor yoke for flat panel monitors .
Double monitor yoke for flat panel monitors .
Instrument trays .
Trays for CRT monitors
24V DC battery backup support .
. Low profile wall control unit
Integrated laser pointer .
Sterilizable handle sleeves

AI/ML Overview

The provided document is a 510(k) summary for the Mach LED 2SC surgical lamp, which is a medical device for illuminating surgical fields. The information requested in the prompt is typically found in studies specifically designed to validate the performance of AI/ML or diagnostic devices against certain criteria. This document, however, focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing the design and results of such performance validation studies.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this specific regulatory submission for a surgical lamp.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document speaks to "performance testing" to meet requirements for "Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group." However, specific acceptance criteria and detailed reported device performance in a tabular format are not explicitly provided in this summary. The comparison table focuses on technological characteristics rather than performance metrics against acceptance criteria.

Technical Parameter	New Device (Mach LED 2SC)	Predicate Devices (Mach LED 3SC, Mach LED 5SC)	Acceptance Criteria for performance	Reported Device Performance
Number of LEDs	21	Mach LED 3SC: 28, Mach LED 5SC: 40	(Implicit from "reduced")	(Met, as the device was cleared)
Illumination Depth	Reduced	(Not quantified)	(Implicit from "reduced")	(Met, as the device was cleared)
Light Intensity	Reduced	(Not quantified)	(Implicit from "reduced")	(Met, as the device was cleared)
Light Head Diameter	Reduced	(Not quantified)	(Implicit from "reduced")	(Met, as the device was cleared)
Electrical Safety & EMC	Meets EN 61000 and relevant standards	(Not quantified for predicates)	Requirements of EN 61000 group and other relevant standards for Medical Electrical Equipment	Performance testing conducted to verify requirements are met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "performance testing" but does not detail the sample sizes or data provenance for such tests. This is a physical device, not an AI/diagnostic software, so the concept of "data provenance" in the context of image data or patient records is not directly relevant here. The manufacturing location is Ebersberg, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The device is a surgical lamp, which does not require "ground truth" established by experts in the way an AI diagnostic tool would. Performance is typically measured using physical instruments and standardized testing procedures.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments or disagreement resolution in diagnostic studies, which is not the case for a surgical lamp's technical performance.

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

This information is not applicable/not provided. MRMC studies are specific to diagnostic tools, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a surgical lamp and does not involve "human readers" in a diagnostic context or AI assistance.

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

This information is not applicable/not provided. This device is a physical surgical lamp, not an algorithm, so the concept of "standalone performance" in this context is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. Ground truth, as typically understood in AI/diagnostic studies, is not relevant for the performance testing of a surgical lamp. Its performance is measured against technical specifications and safety standards.

8. The sample size for the training set

This information is not applicable/not provided. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable/not provided. As above, there is no "training set" for this physical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo for "Dr. Mach Medizinische Leuchten + Technik". The logo features the company name in a bold, sans-serif font, with the "Dr. Mach" portion being larger and more prominent. Below the name, the words "Medizinische Leuchten + Technik" are written in a smaller font. To the left of the logo is a partial illustration of a surgical lamp, suggesting the company's focus on medical lighting equipment.

510(k) Summary for Mach LED 2SC

as required by section 807.92(c)

Submitter

Dr. Mach GmbH & Co.KG

Flossmannstrasse 28 85560 Ebersberg Germany

Contact Person

Preparation Date Trade Name Common Name Classification Name

Predicate Device

Rainer Adams Technical Director

Phone: +49 8092 209330 +49 8092 209350 Fax:

February 14, 2014

Mach LED 2SC

Surgical Lamp

Surgical Lamp Regulation 21 CFR 878.4580, Class II Product Code: FSY

Mach LED SC Surgical lamp

510(k) No. K093009, April 1, 2010

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a logo for "Dr. Mach Medizinische Leuchten + Technik". The logo features the text "Dr. Mach" in a stylized font, with the words "Medizinische Leuchten" and "+ Technik" appearing below in a smaller font. The image also includes a partial illustration of a medical lighting device.

Device Description

The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.

The Mach LED 2SC consists of lamp housing, LED modules, optical -/electrical and mechanical components, one sterilizable handle sleeve as well as the cables.

One LED-module consists of one white LED.

The light system is operated by a kevpad on the lamp head or, by special request of the customer, by a keypad on the wall.

The surgical light Mach LED 2SC will be marketed with merging of light fields and light intensity control. Color temperature adjustment will not be available.

Available accessories for the Mach LED 2SC lighting systems are as follows:

Camera module .
Remote control of camera module .
Remote control with network interface for camera module .
Single monitor yoke for flat panel monitors .
Double monitor yoke for flat panel monitors .
Instrument trays .
Trays for CRT monitors
24V DC battery backup support .
. Low profile wall control unit
Integrated laser pointer .
Sterilizable handle sleeves

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a logo for "Dr. Mach Medizinische Leuchten + Technik". The logo is in black and white and features a stylized font. The image also shows a partial view of a medical examination light.

Intended Use

The Mach LED 2SC lighting system is designed for illuminating an examination area and surgical field at the hospital and doctor's practice.

The intended use is identical to the intended use of the predicate device Mach LED SC, K093009.

Technological characteristics Comparison

The Mach LED 2SC has the same technological characteristics (design, materials, chemical composition, energy source) as the predicate device. The Mach LED 2SC and the predicate device Mach LED SC are both based on the LED (light-emitting diode) technology.

For the new device, the number of LEDs was reduced. Therefore, dimensions of the light head diameter, the illumination depth, and the light intensity have been reduced accordingly.

Technical Parameter	New Device	Predicate Devices
	Mach LED 2SC	Mach LED 3SC	Mach LED 5SC
Number of LEDs	21	28	40

Non-clinical data

Performance testing was conducted to verify that Mach LED 2SC meet the requirements for Medical Electrical Equipment as defined in the relevant standards for Medical electrical equipment and the EN 61000 group.

The accessories are identical to those used with the predicate device.

The risk analysis method used to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA). The design verification test methods used are the same as those submitted for the predicate device submission.

Clinical data

No clinical data is required for this device classification submission.

Conclusions

The modifications incorporated into the Mach LED 2SC design are minor (change in number of LEDs). Based on the information provided herein it is concluded from the performed testing that the device is as safe, as effective, and performs as well as the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, possibly representing the flow of health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 3, 2014

Dr. Mach GmbH & Co., KG % Gudrun Busch, Ph.D. Dr. Busch Regulatory Strategy GmbH Fehmarnstrasse 31 Norderstedt, Schleswig-Holstein 22846 Germany

Re: K140460

Trade/Device Name: Mach LED 2SC Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: February 27, 2014 Received: March 05, 2014

Dear Dr. Busch:

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 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

{4}------------------------------------------------

Page 2 - Gudrun Busch, Ph.D.

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

Felipe Aguel

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140460

Device Name

Mach LED 2SC

Indications for Use (Describe)

The surgical light Mach LED 2SC is intended to illuminate the surgical field and the patient.

Type of Use (Select one or both, as applicable)

[区] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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.