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The surgical light, CHROMOPHARE® D 530 LDR, is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new Berchtold CHROMOPHARE® D 530 LDR surgical light is suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light quality is based on an optical double filter technique. The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux. The light has features like a suspension mechanism will allow to move the light head motordriven up and down, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. The new suspension allows the surgeon to move the light out of the treatment area, which is of interest e.g. in labor and delivery rooms. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.

This document is a 510(k) summary for a surgical light, the CHROMOPHARE® D 530 LDR. It seeks substantial equivalence to a predicate device, the CHROMOPHARE® D 500, based on safety and performance standards, not a clinical study involving specific acceptance criteria or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-powered device is not applicable to this document.

The document does state:

• Device Performance (as described): The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux. It offers a "natural (whiter)" and "colder" light based on an optical double filter technique. It also has features like motor-driven light head movement, auto-switching to a second lamp upon main lamp failure, and an easy-to-exchange lamp cartridge.
• Study Proving Device Meets Acceptance Criteria: The document states that the device "has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety." This indicates compliance testing to established safety standards, which serve as the "acceptance criteria" in this context. It also states, "Safety of the lights, as indicated above, has been established by meeting the requirements of IEC 601 and UL 544."

No other information relevant to your specific questions about AI algorithm performance, sample sizes for AI training/testing, expert ground truth, or MRMC studies is present in this regulatory submission.

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