(42 days)
The iLED lighting system is for illuminating an examination and surgical site on the patient in the clinic and doctor's office. The surgical light iLED is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow fee, "cold" light.
The iLED surgical light is suitable for all types of surgical procedures. The iLED light heads consists of several hexagonal modules, which contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. The iLED5 has one center module and four edge modules; the iLED3 has three edge modules for the illumination. Each light head has its own control to adjust the illumination parameters. The light intensity is adjustable between 30% and 100%, the color temperature between 3500 K and 5000 K. A dimming of the light to the point of an application at endoscopical working is possible and a adaptability to different situations (shadow control) to improve the illumination of the surgical field. With the use of LEDs as light sources, TRUMPF realizes a high illumination intensity with a low heat radiation and a durability of at least 4 times compared with gas-discharging lamps. The light incorporates easy-to-operate swivel arms and can be combined to systems with one, two or three light heads of the type iLED3 or iLED5. An optional CCD-video-camera is available and the light could be combined with TRUMPF KREUZER ceiling mounted support systems.
The provided text is a 510(k) summary for the TRUMPF KREUZER Medizin Systeme GmbH + Co. KG iLED surgical lamp. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in a medical AI context. The device described is a physical surgical lamp, not an AI software/device.
Therefore, I cannot provide the requested information as it is not present in the given input.
Reasoning for inability to answer the requested details:
- Acceptance Criteria & Device Performance Table: The document details the physical characteristics of the iLED surgical lamp and compares it to a predicate device (CHROMOPHARE X 65) based on its light source (LED vs. gas-discharge lamp), number of light sources, and expected lifespan. It states that "Any difference that exists between the CHROMOPHARE X65 and the iLED has no negative effect on safety or effectiveness and actually enhances the usefulness in the chosen application." However, it does not provide specific quantitative acceptance criteria or a table of performance metrics for the iLED compared to these criteria.
- Sample Size, Data Provenance, Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Training Set: These concepts are typically associated with the evaluation of artificial intelligence (AI) or machine learning (ML) models, particularly in medical imaging or diagnostics. The iLED is a surgical lamp, a physical medical device. The 510(k) summary provided describes the device, its intended use, and its substantial equivalence to a predicate device for regulatory purposes. It does not involve any AI/ML components, and thus, terms like "test set," "ground truth," "experts," "adjudication," "MRMC study," "standalone performance," or "training set" are not applicable or mentioned in this context.
§ 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.