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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.

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