The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The system consists of a center-mounted lighthead suspension, which supports horizontal arms of possible differing lengths and lighthead assemblies and operates via an electronic control system. Optional features for the system include a fiber optic light for task lighting, voice control of the system via the HERMES system, a camera integrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The system components can be arrayed to produce various system configurations depending upon the needs of the user. The Amsco Harmony Surgical Lighting and Media System has a sterile disposable sheath for postioning of the sterile field during surgical procedures. The sterile sheath is latex free and is made of approved medical grade material. The Amsco Harmony Surgical Lighting and Media System is designed to assure compilance with IEC 60601-2-41 (Ed.1.0 (2000-02) Medical Electrical Equipment - Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis, IEC 60601-1 (Electrical Safety US, Canada). The device carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Amsco® Harmony Surgical Lighting and Media System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it explicitly states that clinical testing was not performed, and therefore, no study proving the device meets specific acceptance criteria is included.

The document focuses on non-clinical testing and comparison to predicate devices' specifications.

Here's an analysis based on the information provided, highlighting the absence of a study proving the device meets acceptance criteria:

A table of acceptance criteria and the reported device performance

The document provides a comparative table of specifications between the Amsco Harmony Surgical Lighting and Media System and its predicate devices. While these are specifications and not explicitly labeled acceptance criteria, the implication is that matching or demonstrating similar performance to predicate devices is a form of acceptance criterion for substantial equivalence.

Item	Predicate Device (Amsco SQ240, Hill-Rom BrightStar, Berchtold Chromophare "D-series")	Amsco Harmony Surgical Lighting and Media System Performance
Illumination Area	(Range from 7-8.5" to 11" for diameter, 20-31.5" for depth)	large: 6-14" (diameter), medium: 5-12" (diameter), small: 8" (diameter)
Light beam diameter		30" (depth)
Light beam depth
Light focusing mechanism	Fixed or Adjustable (varies by predicate)	Adjustable
Illumination @ 1m	9,293 (100,000) to 12,000 (130,000) Foot-candles (Lux)	large: 13,000 (140,000), medium: 12,000 (130,000), small: 6,000 (65,000)
Color Temperature (°K)	4,200°K to 4,500°K	4,400°K
UV (≤400nm) Output	< .014 watts/cm² (for Amsco SQ240, others not available)	< .001 watts/cm²
Light source	Tungsten Halogen Bulb, Halogen Quartz Bulb, Xenon Halogen Bulb	Tungsten Halogen Bulb
UV light filter mechanism	Dichroic Reflector, IR Glass, Glass/film	Dichroic Reflector (cold filter)
Adjustable pattern	Yes	Yes
Focal length	1 meter / 42 inches	1 meter
Rotation	360°	360°
Mounting options	Varied (single, dual, triple arm; track; ceiling from center point)	single, dual, triple arm; optional "H" frame; optional AV arm; wall mount; floor stand
Number of lamps	1 main, 1 reserve	large: 1 main, 1 reserve (auto-lamp change), medium: 1 main, 1 reserve (small: 1 main, no reserve)
Lamp voltage	22 VDC to 24 VDC	large & medium: 21VDC; small: 21VDC

The document states: "The Amso Harmony Surgical Lighting and Media System meets its intended use of effectively providing visible illumination of the surgical field or the patient." This is a general claim based on the non-clinical comparison.

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

No clinical test set was used. The document explicitly states: "Discussion of clinical tests: For the Amsco Harmony Surgical Lighting and Media System clinical testing was not performed; bench testing is used to assure the safety and efficacy of the device."
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, as no clinical test set was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.
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 device is a surgical light, not an AI-assisted diagnostic tool. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical evaluation, the "ground truth" implicitly used were the published specifications and performance characteristics of the predicate devices. The new device's performance was measured against these established benchmarks.
The sample size for the training set

Not applicable. This device does not use machine learning or AI models, so there is no training set.
How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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510(k) SUMMARY DEC 1 3 2001 Pertaining to the Safety and Effectiveness of the Amsco " Harmony™ Surgical Lighting and Media System

Submitter Information: STERIS Corporation

2720 Gunter Park Drive E. Montgomery, AL 36109 Tel: 334-213-3150 Fax: 334-271-3579 Robert H. McCall Sr. Regulatory Affairs Specialist

Date Summary Prepared: September 26, 2001

Name of the device:

Amsco® Harmony Surgical Lighting and Media System

Common or usual name of the device: Light, Surgical

Classification name of the device: Surgical Lamp

Predicate Devices:

Device Description:

Amsco SQ240 Surgical Light, Hill-Rom BrightStar Surgical Light and Berchtold Chromophare D650 Surgical Lights

The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern,
the surgical The Amsco Harmony Surgical Lighting and resident in the surgical in variable intensity surgical lights designer is provedural support for the O.R. staff. The field or the pattent and to provide accident of a system consists of a center-mounted
Amsco Harmony Surgical Lighting and Media System consists and lighthe Amsco Harmony Surgical Lighting and Mood Cossible differing lengths and lighthead
suspension, which supports horizontal arms of possible discussion for the system suspension, which supports nortzonal and or orcharder. Optional features for the HERM assemblies and operates via an elections voice control of the system via the HERMES
include a fiber optic light for task lighting, voice control of the system via the HERMES include a fiber optic light for ask lighting, for vegrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The systems standard of hat screen momor of a mga enous system configurations depending upon the components can be arrayed to produce various of calable System has a sterile needs of the user. The Amseo Transmy Start as needed and maintenance of the sterile disposable sheath for postdoming of the sterile sheath is latest free and is made of approved
field during surgical procedures. The sterile sheath is blackting and Madia Sust tield during surgical procedures: The Jersen Surgical Lighting and Media System is
medical grade material. The Amsco Harmony Surgical Lighting and Medical medical grade material. The Alliber Hith IEC 60601-2-41 (Ed.1.0 (2000-02) Medical designed to assure compilance with IDC 600 mirements for the Safety of Surgical Electrical Equipment - Fart 2-11-2 and Childers for Diagnosis, IEC 60601-1 (Electrical Station US, 260 Luminates and Lummanes for Diagnolo, I.S. To evice carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.

Intended Use:

The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, I he Amsed Harmony Surgical Lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The freld or the patient and to provide auction to the medical care practitioners in a surgical setting.

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Substantial Equivalence: The Amso Harmony Surgical Lighting and Media System is substantialy guirvalent to
r Surgista Carl Chicked Light Hill Rom RrightStar Surgical Light Substantial Equivalenee: The Amso Surgical Lighting and Media System Sacommend the Amsco SQ240 Surgical Light, Hill-Kolli Brights and differences are listed below.
in function and intended use. Similarities and differences are listed below.

Predicate Device	Amsco Harmony	Amsco SQ240	Hill-Rom BrightStar (Prima)	Berchtold Chromophare "D-series"
Items in BOLD are specifically requested in the Surgical Lamp Guidance Document
Illumination AreaLight beam diameter	large: 6-14"medium: 5-12"small: 8"	178mm - 216mm(7-8.5")	280mm (11")	180mm - 280mm(7.1-11")
Illumination AreaLight beam depth	30"	660mm (26")	510mm (20")	800mm (31.5")
Light focusing mechanism	Adjustable	Fixed	Adjustable	Fixed
Illumination @ 1mFoot-candles (Lux)	large:13,000 (140,000)medium:12,000 (130,000)small:6,000 (65,000)	12,000 (130,000)	12,000 (130,000)	9,293 (100,000)
Color Temperature (°K)	4,400°K	4,400°K	4,200°K	4,500°K
UV (≤400nm)Output (watts/cm²)	< .001 watts/cm²	< .014 watts/cm²	Not Available	Not Available
Light source	Tungsten Halogen Bulb	Tungsten Halogen Bulb	Halogen Quartz Bulb	Xenon Halogen Bulb
UV light filter mechanism	Dichroic Reflector(cold filter)	Dichroic Reflector(cold filter)	IR Glass	Glass/film
Adjustable pattern	Yes	Yes	Yes	Yes
Focal length	1 meter	42 inches	1 meter	1 meter
Rotation	360°	360°	360°	360°
Mounting options	single, dual, triple arm; optional"H" frame; optional AV arm;wall mount; floor stand	single, dual or triplearm; track; optional AVarm	Ceiling from centerpoint	Ceiling from centerpoint
Number of lamps	large: 1main, 1 reserve (auto-lamp change)medium: 1main, 1 reservesmall: 1main, no reserve	1main, 1 reserve	1main, 1 reserve	1main, 1 reserve
Lamp voltage	large & medium: 21VDCsmall: 21VDC	22 VDC	24 VDC	22.7 VDC

in the Surgical Lamp Guidance Document

The Amso Harmony Surgical Lighting and Media System is substantially equivalent to the predicate Surgical Lighting and Media System The Amso Harmony Surgical Lightin System is substailiaus Survace. I war and Madia System
Lights. The minor differences described Amso Harmony Surgical Light of eathy of east Lights. The minor differences described bove between the Amso Brainers of sates of effectiveness. The shegation and that of the predicate Surgical Lights on the systems are the same. The device does not
intended used to the concertibility is not a concern intended use, basic technology, and point.
contact the patient, so biocompatibility is not a concern.

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Discussion of non-clinical tests

Like the predicate device(s), the Amso Harmony Surgical Lighting and Media System will utilize existing lighting Like the predicate device(s), the Amson Surgical Lighting and Neduct Openholm on Sectifications such as,
technology to position the light of the consis control asepsis contro Extection the light the light to deliver illumination to the operations of disposable sterile
optical characterisites, drift-free performance, and surgical asepsis control th optical characteristics, drift-free performance, and surgently and the prove substantial.
covers are among the aspect that have been examied to compare to the prove substanti opires are among the aspects that have been examined to compare to the prediction in the province in and one been examined to
equivalence. Dimensional specifications and/or t equivalence. Difficilisional specifican
ensure the device meets human factors considerations.

Discussion of clinical tests

Directors of Harmony Surgical Lighting and Media System clinical testing was not performed; bench testing is
and the contraction of the most of the davice For the Amseo Harmony Durgery and efficacy of the device.

Conclusions drawn from the non-clinical and clinical tests

Doced on the non-clinical testing of the Amsco Harmony Surgical Lighting and Media System, there are no new Based on the non-clinical testing of the Amso Harmony Surgical Lighting And Media System
questions of safety or efficacy that have been raised. The Amso Harmony Surgical Incl questions of safety or efficacy that have been raised. The Allaoo Hamber of the surgical field or the patient.
meets its intended use of effectively providing visible illumin

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2001

Laura Green Manager, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834

Re: K013242

K013242
Trade Name: Amsco Harmony Surgical Lighting and Media System Regulation Number: 878.4580 Regulation Name: Surgical Lamp Regulatory Class: II Product Code: FTD Dated: September 27, 2001 Received: September 28, 2001

Dear Ms. Green:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IV(I) plethated in substatially equivalent (for the referenced above and we have determined the actives is streted in in interstate commerce prior to
indications for use stated in the enclosure) to devices Amendments or to dev indications for use stated in the enclosures in actives institutions, or to devices that have May 28, 1976, the enactment date of the Wedren Device Andrialians, Crue, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal Food, Drug, been reclassified in accordance with the provisors of onlication (PMA). You may.
(Act) that do not require approval of a premarket apprisions of the Act. The gen (Act) that do not require approval of a plenial controls provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of the e therefore, market the device, subject to the general registration, listing of devices,
controls provisions of the Act include requirements for ammanshapping and adulteration. controls provisions of the Act include requirements for alliad. Februaries and adulteration.
good manufacturing practice, labeling, and prohibitions against misbranding and a

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into entire) cass if epould oos affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controis. Extraig major regantes be found in the Code of Federal Regulations, Trile 24, This 24, 2017, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 1991,

Please be advised that FDA issuance of a substantial equivalence determination does not mean
ts of the Actively of a start any device complies with other requirements of the Please be advised that FDA's issuance of a substance outbex with other requirements of the Act
that FDA has made a determination that your device onmplies with other require that FDA has made a determination inal your development Federal agencies. You must
or any Federal statutes and regulations administered by other to: registration and listi or any Federal statutes and regulations and united to: registration and listing (21
comply with all the Act's requirements, including, but limited to: requirements as set comply with all the Act s requirently, nicitating practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if anylicable, the electron CFR Part 807); labeling (21 CFR Patl on ); good manates 200; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050. forth in the quality systems (QS) regulation (21 OF R Parc 22) - 11:42 PM 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Laura Green

This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the submit and experiences and equivalence of your device to a legally This letter will allow you to begin marketing your device as useness are a regally
premarket notification. The FDA in a lassifises in your device and thus, permits your devi premarket notification. The FDA finding of substantial equivalite of 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 CPR Part 801 and If you desire specific advice for your devices devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitte diagnostic devices, please contact the orde additionally 21 CFR Part 809.10 for mitto different on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the provincial of Compliance at (301) 594-4659. Additionally, Int questions on and the may of the mote the your device, please contact the Office of Conification" (21CFR Part Mr.97).
regulation entitled, «Misbranding by reference to premation notification» (1) var the regulation entitled, «Misbranding of responsibilities under the Act may be obtained from the Other general information on your responsional one Assistance at its tollars.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number Division of Small Mailtiractares, or at its Internet address
(800) 638-2041 or (301) 443-6597 or at its Internet address (800) 656-2014 gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Susan Walk, MP

Image /page/4/Picture/4 description: The image shows a black and white close-up of a signature. The signature appears to be stylized and abstract, with curved lines and a few sharp angles. The signature is positioned in the lower-left corner of the image, and the background is plain white.

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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Attachment 2

Indications for Use Statement

510(k) Number	K013242
(if known)
Device Name	Amsco ® Harmony Surgical Lighting and Media System
Indications for Use	The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED
E

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Walk
Sign Off

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

510(k) Number K013242

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

268

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.