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Hanaulux blue 75 / 120 are surgical luminaires used in the patient area and intended to illuminate locally the body of the patient. They are installed as a system of one, two or three luminaires and are intended to support the treatment and diagnosis. They are intended to be used in operating rooms and not for direct contact with patient.

Hanaulux blue 75 / 120 is an Examination and Surgical Light with two lighthead combinations of blue 75 and blue 120. The Hanaulux® blue 75 / 120 is principally the same as the Hanaulux(") blue 30 / 80 in design, material and function. They are intended for illumination purpose and are not intended for therapeutic use and direct contact with the patient.

All used plastics are molded of UL Recognized Component material.

All internal wiring is either Listed fixture wire or Recognized Component appliance wiring material.

The maximum of UV Irradiance is lower then 6 W / m² .

Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code. The system is intended to be connected to a remote, listed, isolating type, 24V transformer.

This document describes the premarket notification (510(k)) for the Heraeus Hanaulux blue 75 and Hanaulux blue 120 surgical and examination luminaires. This submission focuses on the substantial equivalence of these devices to previously marketed devices and compliance with safety standards rather than clinical performance studies. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted or inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are primarily related to safety standards and functional equivalence to predicate devices, rather than specific performance metrics in a clinical context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes a premarket notification for a medical device (surgical/examination lights), not a clinical study involving a test set of data. The "study" mentioned here refers to compliance with standards and demonstrating substantial equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is not a clinical study with a test set requiring ground truth, no experts were used in this capacity. The evaluation involved regulatory bodies (FDA) reviewing technical specifications and comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. This device is a surgical/examination luminaire; it is not an AI-assisted diagnostic or interpretative device, and therefore, no MRMC study was conducted.

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

Not applicable. This device is a physical medical light, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this regulatory submission is compliance with established electrical and medical device safety standards, and functional equivalence to legally marketed predicate devices, as assessed through engineering specifications and regulatory review.

8. The sample size for the training set

Not applicable. This is not a machine learning device or a clinical study that would involve a training set.

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

Not applicable. As there is no training set mentioned, this question is not relevant.

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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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