Search Results

The Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.

Not Found

The provided document is a 510(k) clearance letter from the FDA for "Laser Peripherals Holmium Bare Fibers." This type of document establishes substantial equivalence to a predicate device but does not typically contain detailed acceptance criteria, study designs, or performance results in the same way a pre-market approval (PMA) application or a peer-reviewed study publication would.

Based solely on the provided text, I cannot answer the requested questions as the information is not present. The letter confirms market clearance but does not describe the specific studies or data used to demonstrate safety and effectiveness beyond stating substantial equivalence to a predicate device.

Therefore, I must state that the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not available in the provided document.

Ask a specific question about this device