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The Disposable Light Handle is a sterile product. It is intended to be used as an accessory to Surgical Lamps. This Disposable Handle provides a sterile interface between the operating room Surgical Lamp (non-sterile), and the Surgeon or Scrub Nurse (sterile)

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This document, an FDA 510(k) clearance letter for the "Disposable Light Handle and Adaptor," does not contain information about acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

The letter is a regulatory document confirming that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA believes the new device is as safe and effective as a device already on the market, based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on specific performance metrics or studies in the format you described.

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