ALM X'Ten™ (X10) Surgical Light Systems with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient.

An optional "LEDinside" feature is available and produces lower intensity levels of illumination intended for minimally invasive surgeries, procedures and examinations.

The Energix™ Power Supply is intended for use with surgical light systems.

Device Description

The ALM X'Ten'M Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principals as the Angenieux (AX) Series Surgical Light Systems. The primary predicate device focuses on comparisons to the Angenieux® AX10, which is the medium sized lighthead within the Angenieux® (AX) Series.

The ALM X'Ten™ Surgical Light provides a broadened set of features and options that include video camera and flat screen display capabilities, bulb failure indicator(s), and an ambient light mode ("LEDinside") as results from this redesign effort. The user can toggie from the Surgical Light mode to the Ambient Light mode via use of a keypad switch mounted on the yoke of the lighthead. The "LEDinside" mode presents a ring of light mouthed from the bottom surface of the light, centered on the outer periphery of the sterile handle. Intensity can be adjusted to four levels: 30, 70, 110 and 150 Lux (@ 1m) and is sufficient to work on the patient in a dim or darkened operating room.

The ALM X'Ten™ Product Family currently has four configurations available, as shown within Table 1.

AI/ML Overview

The provided text describes the ALM X'Ten™ Surgical Light System, but it does not contain a study section with acceptance criteria and a detailed analysis of how the device meets them. Instead, it lists the test data that supports conformance to various safety and performance standards.

Therefore, I cannot fulfill all parts of your request directly from the provided input. However, I can extract the information that is present:

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

The document states that the test data supports conformance to the following standards. These standards themselves contain the acceptance criteria, but the specific performance results from the testing are not reported in this document.

Acceptance Criteria (Standards Conformed To)	Reported Device Performance
UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety	Conformance supported by test data
UL60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics	Conformance supported by test data
CSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Conformance supported by test data
CSA C.22.2 No. 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics	Conformance supported by test data
IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics	Conformance supported by test data
EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests	Conformance supported by test data
FCC Part 15	Conformance supported by test data
Appropriate FDA Software Guidance Documents (for Minor Level of Concern software)	Tested according to these documents

2. Sample size 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 in the document. The text only states that "test data supports conformance" but does not detail the testing methodology, sample sizes, or provenance of the data.

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 provided in the document. The testing described is against engineering and safety standards, not clinical ground truth established by experts.

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

This information is not provided in the document.

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:

No. An MRMC study was not done. This device is a surgical light system, and the filing indicates "No clinical data is required for this device classification submission." This type of study is typically associated with diagnostic AI systems.

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

Not applicable. This device is a surgical light system, not an algorithm, and its performance is assessed against technical safety and performance standards rather than in a standalone diagnostic context.

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

The "ground truth" for this device's performance is defined by its adherence to established international and national safety and performance standards for medical electrical equipment and surgical luminaires (e.g., UL 60601-1, IEC 60601-2-41). It is not based on clinical "ground truth" like pathology or outcomes data, as clinical data was not required.

8. The sample size for the training set:

Not applicable. This device is a physical surgical light system, not an AI model that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

Summary

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MAY 21 2004

K040735

510(k) SUMMARY

ALM X'Ten™ Surgical Light System

Submitted by:	Getinge USA, Inc. (as ALM S.A.'s US Agent)1777 E Henrietta RoadRochester, NY 14623-3133
Contact Person:	Frederick R. CattSenior, Regulatory EngineerPhone: (585) 272-5013Fax: (585) 272-5299
Date prepared:	March 19, 2004
Proprietary Name:	ALM X'TenTM Surgical Light System
Common Name:	Surgical Light
Device Classification:	Surgical Lamp (78 FSY)Class II, as listed per 21 CFR 878.4580
Predicate Device:	ALM Angenieux® (AX) Series Surgical Light [K904965]

Description of Device:

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mounted on the yoke of the lighthead. The "LEDinside" mode presents a ring of light mouthed from the bottom surface of the light, centered on the outer periphery of the sterile handle. Intensity can be adjusted to four levels: 30, 70, 110 and 150 Lux (@ 1m) and is sufficient to work on the patient in a dim or darkened operating room.

The ALM X'Ten™ Product Family currently has four configurations available, as shown within Table 1.

Table 1

ALM X'Ten TM Surgical Light and Systems –Designations/Configurations
Model	Description
X10 DF	X'TenTM SURGICAL LIGHT, CEILING MOUNTED, ONE X10 LIGHTHEAD
X10 duo DF	X'TenTM SURGICAL LIGHT, CEILING MOUNTED, TWO X10 LIGHTHEADS
X10 duo DF V	X'TenTM SURGICAL LIGHT, CEILING MOUNTED, TWO X10 LIGHTHEADSWITH ONE OF THOSE INCLUDING VIDEO PREWIRING AND AMBIENTLIGHT ("LEDinside" FUNCTION)
X10 duo DF V FS	X'TenTM SURGICAL LIGHT, CEILING MOUNTED, TWO X10 LIGHTHEADSWITH ONE OF THOSE INCLUDING VIDEO PREWIRING AND AMBIENTLIGHT ("LEDinside" FUNCTION), AND ONE FLAT SCREEN SUPPORT

Note: Additional model configurations are planned for development. These will be incorporating use of the ALM X'Ten™ lighthead subassemblies.

Intended Use:

The ALM X'Ten™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient. The "LEDinside" ambient light mode is intended for minimally invasive surgeries, procedures and examinations.

Nonclinical Comparisons to Predicate Device

The ALM X'Ten'™ Surgical Light (subject device) is similar to the predicate device with the following modifications:

The ALM X'Ten™ Surgical Light uses the Energix™ Power Supply (WPS) to . provide the electrical power to the light source. Surgical Light intensity levels are adjustable from the Energix keypad or remotely with RS232 communication port option. Bulb failure indicators provided. Optional LCD provides operation and maintenance information about the surgical light system, lightheads and bulbs.
The ALM X'Ten™ introduces the "LED inside" option feature. This is an ambient . light used to illuminate a larger patient area and is intended for minimally invasive surgery applications. Controls are located on the yoke keypad for switchover from Surgical Light to Ambient Light. "LED inside" light level adjustments are at 30, 70, 110 and 150 Lux.

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Added Capabilities of Video Camera (fixed focus or zoom), Multi-Media and Flat . Screen Displays (Note: ALM X'Ten™ with "LED inside" feature is included) similar to the ALM PrismAlix® (PRX) Series Surgical Lights.
Added an optional adapter for single use sterile sleeves/gloves on a standard . handle system.
Modified lighthead design, updating its appearance and suspension means. .

Test Data:

The test data supports conformance to:

UL 60601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements . for Safety
UL60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for . the safety of surgical luminaires and luminaires for diagnostics
CSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for . Safety
CSA C.22.2 No. 60601-2-41 Medical electrical equipment Part 2-41: Particular . requirements for the safety of surgical luminaires and luminaires for diagnostics
IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for . the safety of surgical luminaires and luminaires for diagnostics
EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety . - Collateral standard: Electromagnetic compatibility - Requirements and tests
. FCC Part 15
Software used in the ALM X'Ten™ Surgical Light was tested according to the . appropriate FDA Software Guidance Documents, per its determination as a Minor Level of Concern.

Clinical Data:

No clinical data is required for this device classification submission.

Conclusion:

The modifications incorporated into the ALM X'Ten™ Surgical Light System designs use those desired design features from both the ALM PrismAlix® (PRX) Series and Angenieux® (AX10) Surgical Light Systems. Based upon the information provided herein this 510(k) Premarket Notification, we conclude that ALM X'Ten' Surgical Light Systems are substantially equivalent to the predicate device(s) and is safe and effective when used as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

ALM S.A. c/o Mr. Frederick R. Catt Senior Regulatory Engineer Getinge USA, Inc 1777 East Henrietta Road Rochester, New York 14623

Re: K040735

K040733
Trade/Device Name: ALM X Ten™ Surgical Light System with Energix™ Power Supply Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: TSY Dated: April 30, 2004 Received: May 3, 2004

Dear Mr. Catt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) to regarry the Medical Device Amendments, or to commerce prior to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not requent to the general controls provisions of the Act. The You may, therefore, manxet the act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classified (600 a00 vyrols. Existing major regulations affecting your device can may be subject to such additional controlio visitions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I DTT Pressan that your device complies with other requirements of the Act that IDA has Inade a dotermissions administered by other Federal agencies. You must or any recetal statutes and regulanents annouding, but not limited to: registration and listing (21 Comply with an the Hec oreense than and the start $01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Frederick R. Catt

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premaired notification. The PDF mailing of cation 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 If you desire specific advice for your as (301) 594-4659. 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 other gelleral information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia 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 (if known): K 040735

Device Name: ALM X'Ten™ Surgical Light System with Energix™ Power Supply

Indications for Use:

ALM X'Ten™ (X10) Surgical Light Systems with Energix™ Power Supply are intended ALM X Tell "" (X10) Surgical Elght Systems hands in the surgical area or the patient.

An optional "LEDinside" feature is available and produces lower intensity levels of An optional LEDIffside Teature is a railable and procedures and examinations.

The Energix™ Power Supply is intended for use with surgical light systems.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K040735

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.