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Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms.

Double light

The combination of two operating lights as an operating light system enables the use in operating and treatment rooms.

Versions

• Polaris 100 light

• Polaris 200 light

The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used.

The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures.

The provided document is a 510(k) summary for the Dräger Polaris 100/200 surgical lamp. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML device performance or clinical trials as typically expected. Instead, it describes performance testing related to general medical electrical equipment standards.

However, I can extract information related to the performance testing that was conducted to verify the device's compliance with safety and effectiveness standards for a surgical lamp.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance testing was conducted to verify that the proposed Polaris 100/200 Surgical lamp meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41."

It does not provide a table of specific numerical acceptance criteria (e.g., minimum illumination intensity, color rendering index, etc.) for each parameter from these standards, nor does it report the specific measured performance values for the Polaris 100/200 against those criteria. It only states that the device "meet the requirements."

An example of what such a table would look like if the information were available might be:

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The performance testing described is likely type testing conducted on a sample of manufactured devices (e.g., one or more units of the Polaris 100 and Polaris 200) to confirm design compliance with standards, rather than a clinical study with a test set of data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. For a surgical lamp, "ground truth" is typically established by objective measurements against engineering and performance standards (like IEC 60601-2-41) using calibrated equipment, not by expert consensus in the way it would be for diagnostic imaging or AI algorithms.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies, not for the direct measurement of a physical device's performance against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret medical images, often with and without AI assistance. The Dräger Polaris 100/200 is a surgical illumination device, not a diagnostic imaging tool or AI product.

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

No, a standalone study was not done. This term applies to the performance of an AI algorithm independent of human interaction. The Polaris 100/200 is a physical surgical lamp, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance testing of the surgical lamp would be based on objective measurements against established performance standards, specifically IEC 60601-1 (Medical Electrical Equipment general requirements) and IEC 60601-2-41 (Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis). These standards define measurable parameters (e.g., illumination levels, color temperature, color rendering, depth of field, shadow reduction, electrical safety) that the device must meet.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Polaris 100/200 is a hardware device; it does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as there is no training set for this type of device.

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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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