Search Results

The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.

The Integra Luxtec MLX Light Source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.

Not Found

I am sorry, but based on the provided text, I cannot extract the acceptance criteria, device performance, or details about a study.

The text is a Medical Device 510(k) clearance letter from the FDA for the "Luxtec MLX Light Source." It confirms that the device is substantially equivalent to legally marketed predicate devices and is being cleared for market.

The letter explicitly states:

• It does not contain details of any specific study conducted by Integra Luxtec, Inc. to prove the device meets acceptance criteria. It refers to the FDA's review of the "Section 510(k) premarket notification of intent to market the device."
• No acceptance criteria or reported device performance are listed. The clearance is based on substantial equivalence, not on specific performance metrics outlined in this document.
• There is no mention of sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or details about training sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the information given.

Ask a specific question about this device