Search Results

The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.

The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.

The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems. Its' intended function and use is to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.

The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures. It is constructed of a durable plastic housing, lenses, spot size adjustment, and positioning bar. It utilizes a proprietary fiber optic cable, the distal end of which will fit an ACMI port. The luminaire optics consist of optic lenses, a mirror, and an iris.

The provided text describes the 510(k) summary for the BFW, Inc. ChromaLUME Turbo Light Source with XtremeBeam Fiber Optic Headlight. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a study design to meet them.

Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

The text explicitly states:

• "The ChromaLUME with XtremeBeam has been tested to and meets IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety." This indicates compliance with a general safety standard, not performance against specific clinical acceptance criteria for illumination.
• The primary purpose of the 510(k) summary is to establish "Substantial Equivalence" to a predicate device (Welch Allyn, Inc. Model ProXenon 350 Surgical Illuminator). This typically means showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety and effectiveness, often by relying on the predicate's established performance rather than conducting new extensive clinical performance trials.

Without a detailed clinical or performance study report, the specific information requested cannot be extracted.

Ask a specific question about this device