The Axcel™ Surgical Light is a new product designation intended to identify a family of surgical lights that will use a similar set of design principals as the PrismAlix® (PRX) Series Surgical Light. The primary predicate device focuses on the PRX4000, which is the smaller lighthead within the PRX Series. Additionally, the Axcel light design also uses some design features from the Angenieux AX4 Surgical Light. Comparisons are made between it and these two predicate devices.

The current Axcel™ Family of Products and Configurations are shown in Table 1 below, along with their associated FDA Product Code(s). There are three configurations and comprise of two (2) ceiling mounted light system configurations (single and two lighthead) and one (1) wall mount system with one lighthead.

AI/ML Overview

This 510(k) summary for the ALM Axcel™ Surgical Light describes the device and its substantial equivalence to predicate devices, but it does not include information about specific acceptance criteria or an explicit study proving the device meets them, as it is understood in the context of performance metrics like sensitivity, specificity, or accuracy that are common in AI/ML medical devices.

Instead, the submission focuses on demonstrating compliance with safety standards and the substantial equivalence of modifications compared to existing predicate devices.

Therefore, the specific quantitative details requested in the prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not available in the provided document.

However, I can extract information about the types of tests conducted and what the "acceptance criteria" can be inferred to be in this regulatory context.

Here's a breakdown of the available information based on your prompt:

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

Since this is a submission for a surgical light, the "acceptance criteria" are primarily related to safety, electrical standards, and functional equivalence to predicate devices, rather than performance metrics like sensitivity or specificity. The document doesn't provide a table of performance results against numerical acceptance criteria in the way an AI/ML device submission would.

Inferred "Acceptance Criteria" (based on standards compliance and substantial equivalence argument):

Inferred "Acceptance Criteria" Category	Description	Reported Device Performance (as stated in the document)
Safety and Electrical Standards	Compliance with recognized national and international safety standards for medical electrical equipment and surgical luminaires.	"The test data supports conformance to:UL 2601-1 Standard for Medical Electrical Equipment, Part 1: General Requirements for SafetyCSA C22.2 No. 601.1 Medical Electrical Equipment, Part 1: General Requirements for SafetyIEC 60601-2-41 Medical electrical equipment Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosticsEN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests"
Software Safety Level	Determination that software poses a minor level of concern.	"Software used in the Axcel™ Surgical Light was tested according to the appropriate FDA Software Guidance Documents, per its determination as a Minor Level of Concern."
Functional Equivalence	The modified design and features are functionally equivalent to the predicate devices and do not raise new questions of safety or effectiveness. (This is the overarching "acceptance criterion" for a 510(k) pathway).	"The modifications incorporated into the Axcel™ Surgical Light designs used those desired design features from both the ALM PrismAlix® (PRX4000 Series) and Angenieux AX4 Surgical Lights. Based upon the information provided herein this 510(k) Premarket Notification, we conclude that the ALM Axcel™ Surgical Light is substantially equivalent to the predicate device(s) and is safe and effective when used as intended."
Intended Use	The device fulfills its stated intended use.	"The Axcel™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient." (This use is considered equivalent to predicates).

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

Sample Size for Test Set: Not applicable in the context of this device and submission type. The testing was for compliance with engineering and electrical safety standards, not a statistical performance test against a "test set" of medical data.
Data Provenance: Not applicable. The "data" here refers to test results from engineering and safety assessments, not clinical 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)

Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for a surgical light's safety and electrical compliance testing. The "ground truth" here is the adherence to engineering standards.

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

Not applicable. This type of adjudication is for resolving discrepancies in expert interpretations of medical data, which is not part of this submission.

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 is not relevant for a surgical light. This device is not an AI/ML diagnostic tool or an aid for human interpretation of medical cases.

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

No. This device is a physical surgical light, not an algorithm. While it contains "Software... determined as a Minor Level of Concern," the submission does not detail standalone performance of this software in a clinical context. Its function is to control light intensity and on/off, not to make diagnostic or therapeutic decisions.

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

The "ground truth" in this context is the established engineering and electrical safety standards (e.g., UL 2601-1, CSA C22.2 No. 601.1, IEC 60601-2-41, EN 60601-1-2) and FDA guidance for software. The device's performance is measured against these technical specifications and regulatory requirements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable.

Summary regarding "the study that proves the device meets the acceptance criteria":

The "study" proving the device meets the acceptance criteria, in this context, consists of nonclinical testing for conformance to recognized safety and electrical standards, along with a comparative analysis of its design and features against legally marketed predicate devices. The conclusion rests on demonstrating that the device is substantially equivalent to existing devices and adheres to relevant safety regulations. The formal "approval" is the FDA's 510(k) clearance letter.

Summary

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APR 2 3 2003

510(k) SUMMARY

ALM Axcel™ Surgical Light

Submitted by:	Getinge/Castle 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 21, 2003
Proprietary Name:	ALM Axcel™ 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® (PRX4000 Series) Surgical Light [K982063]andAngenieux (AX4) Surgical Light [K9049651]

Description of Device:

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ALM S.A. FDA 510(k) Summary Device: Axcel 1 Surgical Light - Models AXL 5001 S, AXL 5501 S, AXL 5002 S

Table 1Axcel™ Surgical Light Systems and Configurations
Model	Description	FDA ProductCode(s)
AXL 5001 S	Axcel™ Model AXL 5001 S is a ceiling mounted light system that contains one AXL 5000 Lighthead.	FSY/FQP
AXL 5002 S	Axcel™ Model AXL 5002 S is a wall mounted light system that contains one AXL 5000 Lighthead	FTD/FQP
AXL 5501 S	Axcel™ Model AXL 5501 S is a ceiling mounted light system that contains two AXL 5000 Lightheads.	FSY/FQP

Intended Use:

The Axcel™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient.

Nonclinical Comparisons to Predicate Device

The Axcel™ Surgical Light (subject device) is similar to the predicate device with the following modifications:

Cosmetic changes to the lighthead, by rounding the overall shape and surfaces for . improved laminar flow characteristics.
. Use of five (5) optical lens/windows, by adding one in the center of the cross layout design, while the Angenieux AX4 surgical light uses four lenses in a cross layout.
Each Axcel™ lighthead incorporates a membrane switch panel that has an . ON/OFF switch and illumination level adjustment switches (+ / --) that is ergonomically mounted within the handle (yoke post) of the lighthead assembly.
The Axcel™ design incorporates the power supply and filter sub-assembly to be . mounted into the suspension tube, rather than being mounted externally on the wall or ceiling.
. The dimmer control is mounted within the lighthead subassembly, near the membrane switch panel.
Software is incorporated within the design, which interfaces with input signals sent . from both the dimmer control and ON/OFF lamp membrane switches and provides output signals used by the dimmer control supplying voltage to the lamps (bulbs).

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The lighthead optical system uses a modified design from the AX4 lighthead . system, by means of using similar microlens windows, central optical system and a similar four dichroic mirror sub-assembly.
Axcel™ lights have a fixed focus and stationary light handle, whereas on both ● predicate devices, focusing means are provided.
The Axcel™ light handle and post location is mounted slightly off-center in one . axis, rather than being mounted in the direct center of the AX4 lighthead. The modified positioning provides an unobstructed space for the center (fifth) optical lens/window. The Axcel light incorporates the same sterilizable light handle as those used on the PRX surgical light.

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 . Safetv
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 Axcel™ 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 Axcel™ Surgical Light designs used those desired design features from both the ALM PrismAlix® (PRX4000 Series) and Angenieux AX4 Surgical Lights. Based upon the information provided herein this 510(k) Premarket Notification, we conclude that the ALM Axcel™ Surgical Light 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle. The logo is black and white.

APR 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ALM S.A. c/o Mr. Frederick R. Catt Senior Regulatory Engineer Getinge/Castle, Inc. 1777 E. Henrietta Road Rochester, New York 14623-3133

Re: K030906

Trade/Device Name: ALM Axcel™ Surgical Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: II Product Code: FSY Dated: March 21, 2003 Received: March 24, 2003

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 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); 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 R. 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. Additionally, for questions on 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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

(ar 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 STATEMENT

510(k) Number:

Device Name:

K030906 Axcel™ Surgical Light

Indications for Use:

ALM S.A. Axcel™ Surgical Lights are intended to be used to provide visible illumination of the surgical area or the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

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

510(k) Number K030906

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.