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The Headlamp HL2000 has indicated use in the following situations:

There is a requirement for illuminating a surgical field. .

· There is a requirement for munimaling on and The doctor wears this device on hishler end to the headlamp. The headlamp contains a
end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

The doctor wears this device on hishler end to the headlamp. The headlamp contains a end to a remote light source and the other end to the headlamp contains a End to a remote inght source and the carcular spot and illuminates the surgical field.

The provided text is a 510(k) clearance letter from the FDA for a device named "HeadLamp, HL2000". This document focuses on the regulatory clearance process and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input. The document explicitly states:

• It is a review of the 510(k) notification and a determination of substantial equivalence.
• It refers to "indications for use" as stated in an enclosure (which is not provided in the text).
• It confirms the device can be marketed subject to general controls.

The text does not detail any performance study or the results of such a study.

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