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The TRUMPF Surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.

TruLight 5520 and 5320 light heads consist of 2 light modules containing LEDs which illuminate the area of a patient. The light heads are equipped with illuminated non-sterile hand grips. The light heads can be controlled on the control panel on the light head or on an optional wall control panel. Illuminance can be adjusted between 30 and 100%. Reducing the Illuminance does not change the color temperature of the light. The illuminance can also be adjusted to "endo" mode, which is 5%. The optional Adaptive Light Control (ALC) feature allows the lighting settings to be selectively adjusted to the working distance. The three settings for a working distance of approx. 0.8, 1.0 and 1.2 meters are selected on the control panel or on the wall control panel. The light head then selects the light setting suitable for this working distance. The Adaptive Light Control Plus (ALC+) offers automatic control of the light intensity. If the light head is moved during surgery, the motion detection function automatically measures the distance between the luminaire and the wound area. The light head then selects the light setting suitable for this working distance.

The provided document is a 510(k) summary for a surgical light (TruLight 5520 and 5320). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria for an AI/CAD-like device. Therefore, much of the requested information regarding AI/CAD-specific study details (such as sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in this document.

However, I can extract information related to the device's performance characteristics and the general approach to demonstrating safety and effectiveness.

Here's the information as best as can be extracted from the provided text:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format. Instead, the document states that the new devices (TruLight 5520 and 5320) were tested to the same standards as the predicate devices and were found to have "similar or improved performance features" and are "not any less safe or effective." The key performance characteristic highlighted is illumination.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable/not provided. This document describes testing for a physical medical device (surgical light), not an algorithm or AI system that operates on a "test set" of data in the common sense for AI/CAD. The "testing" refers to physical product testing protocols and standard compliance.
• Data Provenance: Not applicable/not provided for AI/CAD context. The testing is based on device performance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: "Additional third-party experts" were involved in a risk analysis. A specific number is not provided.
• Qualifications of Experts: Not specified beyond being "third-party experts" involved in a risk analysis.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable/not provided in the context of an AI/CAD test set. The document refers to a "thorough risk analysis by TRUMPF and additional third-party experts."

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:

• MRMC Study: No, this is not an AI/CAD device. Therefore, no MRMC study, human-in-the-loop analysis, or effect size related to AI assistance is mentioned or relevant.

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

• Standalone Performance: No, this is a physical medical device. This concept is not applicable.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" here is compliance with established international and national standards (e.g., IEC 60601-1-2 for EMC, IEC 60825-1 for laser safety) and inherent physical performance characteristics of the surgical light (e.g., illuminance, durability of sterilization). The core claim is "substantial equivalence" to predicate devices, meaning its performance, safety, and effectiveness are comparable.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/CAD device that undergoes a "training" process with a dataset.

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

• Ground Truth for Training Set: Not applicable.

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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.

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