Search Results

The Mauna Kea Technologies F-400 System is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.

The F-400 system is a confocal microscope with a fiber optic probe which allows in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure. The F-400 system has been designed to allow real-time observations of tissues. The device is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers and is thus composed of several elements: a Laser Scanning Unit, proprietary software running on a remote computer, a medical grade flat panel display and Miniaturized Fiber Optic Probes. The F-400 system can be used with any legally marketed endoscope with a working channel of 2.8 mm or greater.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Mauna Kea Technologies F-400 System, focusing on substantial equivalence to predicate devices, device description, and intended use.

The relevant section states:

"Accepted scientific methods were followed to conduct non-clinical testing, i.e., design verification and validation and testing to recognized standards. The purpose of this testing served to evaluate whether safety or effectiveness had been adversely affected by technological differences between the F-400 system and the predicate devices."

And further:

"In conclusion, the data from the non-clinical testing, i.e., design verification and validation and testing to FDA recognized standards demonstrated that the F-400 system is as safe and effective as all of the above mentioned predicate devices."

This indicates that non-clinical testing (design verification, validation, and testing to recognized standards in areas like electrical safety, electromagnetic compatibility, laser safety, biocompatibility, etc.) was performed to demonstrate that the F-400 system is "as safe and effective" as its predicate devices. However, specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and the detailed results of a comparative study for these metrics are not provided in this summary.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or MRMC studies for a performance study. No clinical or comparative effectiveness study data is presented in this document.

Ask a specific question about this device