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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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