ALM S.A. PrismAlix® (PRX) Surgical Lights with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient. The Energix™ Power Supply is intended for use with surgical light systems.

Device Description

The PrismAlix® (PRX) Surgical Light System is an existing product line that will allow modification via the use of an updated Energix™ Power Supply as its means to control the surgical lighthead illumination levels. The updated Energix™ Power Supply contains software that enables additional features and capabilities not available on the earlier version of Energix™ Power Supplies. These include:

a) The power supply and regulators,
b) one or two touch-pad units that provide the user the ability to:
- i) turn on/off one or two lightheads,
- ii) adjust illumination intensity levels and
- iii) additional Light Emitting Diodes (LEDs) are used to indicate:
  - (1) the illumination level,
  - (2) bulb failure sensing and
  - (3) power supply mode: Mains supply: green LED or the switching to a battery back-up system results in the LED indicator changing its color to red.
    An optional RS232 Communication Motherboard is also a new feature that allows shifting An optional ROZOE Ochinanicaa specified distance (50m, 164 ft.) away from the surgical Controls to a romote bite are provided specific user and maintenance type information/data, displayed on a Liquid Crystal Display (LCD) window located on the front information and the Energix™ power supply. The user also has an option to have data communicated to a personal computer (PC).
    The LCD can show information about preventive maintenance type items, including:
1. programming of maintenance inspections
1. storage of operating parameters
1. hours of operation
1. bulb life data
1. self-diagnosis information
1. direct reading of parameters voltage, current, temperature
1. traceable management data serial number, software version number, production and service dates)

AI/ML Overview

The provided text describes a 510(k) summary for a modified surgical light, the ALM PrismAlix® (PRX) Surgical Light with an upgraded Energix™ Power Supply. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a new, innovative medical device from first principles.

Therefore, the requested information elements related to clinical studies, ground truth establishment, expert adjudication, sample sizes, and AI performance are largely not applicable or not explicitly detailed in this type of regulatory submission.

However, I can extract the relevant information regarding acceptance criteria (in this case, conformance to recognized standards) and the "study" (testing) that demonstrates this conformance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Conformance)	Reported Device Performance
UL 2601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety	Test data supports conformance
CSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Test data supports conformance
IEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnostics	Test data supports conformance
EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests	Test data supports conformance
FDA Software Guidance Documents (for Minor Level of Concern software)	Software was tested according to appropriate FDA guidance documents

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

Sample Size: Not specified in the document. This typically refers to the number of physical devices or components tested.
Data Provenance: The document states "Test Data" which implies internal testing conducted by the manufacturer or a contracted testing facility. The country of origin of the data is not specified, but the submission is for a US market regulated by the FDA. The testing conducted would be considered prospective in the sense that it was done specifically to demonstrate compliance for this submission.

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

Not Applicable. The "ground truth" for this type of device (a surgical light system) is established by its adherence to widely recognized safety and performance standards, not by expert consensus on clinical findings. The testing involves objective measurements against predefined limits outlined in the standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. As no expert consensus or subjective assessment is involved, no adjudication method is used. Conformance is determined by objective measurements in line with the referenced standards.

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. This is a hardware device (surgical light) with some integrated software for control. It is not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study is not relevant or performed.

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

Not Applicable. This is not an algorithm-only device. The software present (in the Energix™ Power Supply) controls hardware components (light intensity, on/off, displays status information) and is integral to the device's function, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the predefined requirements and limits specified within the referenced international and national standards (UL, CSA, IEC, EN). The device's performance is measured against these technical specifications.

8. The Sample Size for the Training Set

Not Applicable. There is no mention of a training set as this device does not utilize machine learning or AI models that require training. The software is deterministic control software.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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KO40015 (pg 1 of 3)

510(k) SUMMARY

ALM PrismAlix® (PRX) Surgical Light with Energix™ Power Supply

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:	December 31, 2003
Proprietary Name:	ALM PrismAlix® (PRX) Surgical Light
Common Name:	Surgical Light
Device Classification:	Surgical Lamp (78 FSY)Class II, as listed per 21 CFR 878.4580
Predicate Device:	ALM PrismAlix® (PRX) Series Surgical Light [K982063]

Description of Modified Device:

a) The power supply and regulators,
b) one or two touch-pad units that provide the user the ability to:
- i) turn on/off one or two lightheads,
- ii) adjust illumination intensity levels and
- iii) additional Light Emitting Diodes (LEDs) are used to indicate:
  - (1) the illumination level,
  - (2) bulb failure sensing and
  - (3) power supply mode: Mains supply: green LED or the switching to a battery back-up system results in the LED indicator changing its color to red.

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K040015 (pg 2 of 3)

ALM S.A. FDA 510(k) Summary Power Surgical Light with the upgraded Energix™ Power Supply

An optional RS232 Communication Motherboard is also a new feature that allows shifting An optional ROZOE Ochinanicaa specified distance (50m, 164 ft.) away from the surgical Controls to a romote bite are provided specific user and maintenance type information/data, displayed on a Liquid Crystal Display (LCD) window located on the front information and the Energix™ power supply. The user also has an option to have data communicated to a personal computer (PC).

The LCD can show information about preventive maintenance type items, including:

1. programming of maintenance inspections
1. storage of operating parameters
1. hours of operation
1. bulb life data
1. self-diagnosis information
1. direct reading of parameters voltage, current, temperature
1. traceable management data serial number, software version number, production and service dates)

Table 1

Energix™ Power Supply – Designations/Configurations
Model	Description
WPS443	Example: WPS Power Supply with two 360W Power Modules, two keypads and a RS232 Communication Motherboard
WPS	Base Model Designation [Transformer; plus filter PCB and regulator(s)]
	2 150W Power Module and control keypad
	4 360W Power Module and control keypad
	0 Space holder – No #2 Power Module and 2nd control keypad (single lighthead)
	2 150W Power Module #2 and 2nd control keypad
	4 360W Power Module #2 and 2nd control keypad
	0 Power Module(s) only
	1 Power Module(s), RS232 Communication Motherboard and Battery Backup system/charger (Note: not currently planned for USA distribution)
	3 Power Module(s), RS232 Communication Motherboard

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K040015 (pg 3 of 3)

ALM S.A. FDA 510(k) Summary Device: PrismAlix® Surgical Light with the upgraded Energix ™ Power Supply

Page 3 of 3 December 31, 2003

Intended Use:

The PrismAlix® Surgical Light with the upgraded Energix™ Power Supply is intended to be used to provide visible illumination of the surgical area or the patient. The Energix™ Power Supply is intended for use with surgical light systems.

Nonclinical Comparisons to Predicate Device

The PrismAlix® Surgical Light with the upgraded Energix™ Power Supply (subject device) is similar to the predicate device with the following modifications:

Replacement of the older Energix™ design with an upgraded Energix™ Power . Supply (WPS) that includes use of software, and makes available a low energy remote touch-pad panel per lighthead.
As the RS232 option, the Energix™ can provide the user with product condition . type information via a LCD screen or interfacing with a remote PC.
Software is incorporated within the Energix™ design, which interfaces with input . signals sent from the dimmer control and ON/OFF lamp touch-pads. These switches provide output signals used by the intensity control regulator supplying voltage to the lamps (bulbs) within the corresponding lighthead.
The Energix™ Power Supply can operate up to two lightheads, rated 360W each. ●

Test Data:

The test data supports conformance to:

UL 2601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements . for Safety
CSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for . Safety
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
Software used in the Energix™ Power Supply 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:

Based upon the information provided herein this 510(k) Premarket Notification, we conclude that the ALM PrismAlix® (PRX) Series Surgical Light System using the updated Energix™ Power Supply is 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

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

Re: K040015

Trade/Devicc Name: PrismAlix®(PRX) Surgival Light with Energix™ Power Supply Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: II Product Codes: FSY Dated: December 31, 2003 Received: January 5, 2004

Dear: Mr. Catt:

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 such 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 complics 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); 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.

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Page 2 - Mr. Frederick Catt

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (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 Manufacturers, International and Consumer 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

A 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): K040015

Device Name: PrismAlix® (PRX) Surgical Light with Energix™ Power Supply

Indications for Use:

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

Page 1 of _1

Sister Sign-Ofly inion of General, Restorative . Neurological Devices

K040015

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.