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The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.

The Litex Manufacturing, Inc. Light Handle Adapter is a permanent replacement for the light manufacture's OEM reusable handle and it is designed to be permanently attached to the surgical light.

This document is a 510(k) premarket notification for the "Light Handle Adapters" manufactured by Litex Manufacturing Incorporated. It states that no non-clinical or clinical tests were performed. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and study results.

The document asserts substantial equivalence to a predicate device (American Medical MFG., Inc. Plastic Disposable Surgical Light Handle Cover & Adapters, K915068) based on technological characteristics and function. However, this is a regulatory argument for market clearance, not a report of performance testing against specific acceptance criteria.

In summary, none of the requested information (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is available in this document.

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