Search Results

Model Number 0010-2400 is a fiber optic delivery device intended for use with the GreenLight™ XPS Laser System for its FDA cleared indications for use.

Model Number 0010-2400 is supplied as a single-use, sterile product and is compatible with the GreenLight™ XPS Laser System. It can access the tissue in multiple planes. Model Number 0010-2400 is a liguid cooled delivery device which enables the delivery of up to 180W of power and aids in maintaining a clear environment at the fiber cap.

The provided document describes a 510(k) premarket notification for a medical device, the American Medical Systems Model Number 0010-2400 GreenLight MoXy™ Fiber Optic. This is a special 510(k) submission, indicating a modification to an already cleared device, the Fiber One (K100746). The submission focuses on demonstrating substantial equivalence to the predicate device, rather than a de novo approval.

As such, the document does not contain information related to a clinical study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement in the way one would expect for a new or significantly modified device requiring such studies. The assessment here is based on non-clinical (bench) testing and comparison of technological characteristics to the predicate device.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" for this Special 510(k) are implied by demonstrating that the modified device (Model 0010-2400) maintains substantial equivalence to the predicate device (Fiber One) through non-clinical testing and comparison of specifications.

Ask a specific question about this device