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Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.

This document describes a medical device, the HANAULUX blue 80 Hospital, which is an examination and surgical stand light. It does not describe an AI/ML powered device or a study involving such a device.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria and reported device performance related to a study. The document confirms compliance with safety standards (UL 2601, IEC 601-1, UL 153) and states a maximum UV irradiance (< 8 W/m²), but these are device specifications and regulatory compliance, not performance metrics from a study measuring accuracy, sensitivity, specificity, etc., as would be relevant for an AI/ML device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is a 510(k) summary for a conventional medical device, focusing on its design, function, safety standards, and substantial equivalence to existing devices. It does not mention any kind of study that would generate the type of performance data relevant to AI/ML or diagnostic devices.

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