Search Results

The Bausch & Lomb (B&L) Millennium Peristaltic Pump System is intended for the introduction of Balanced Salt Solution (BSS) into the eye, as well as, the aspiration of fluid/tissue from the eye during ophthalmic anterior surgery. The Millennium Peristaltic Pump System consists of the B&L CX4100 module to be used with the B&L Millennium Microsurgical System and the B&L Peristaltic Phaco Pack, CX5310 sterile single-use accessory pack which consists of the various components/accessories necessary to enable the use of B&L Anterior Handpieces with the Millennium Microsurgical System.

The Peristaltic Pump System consists of a new module and will fit into the existing base of Millennium Microsurgical Systems. It is an anterior only module designed to be used with phacoemulsification. The module is flow based in that it will provide aspiration by means of a peristaltic pump. A peristaltic pump is a positive displacement type of pump which controls flow rate by the rotational speed of the pump head. The module will contain an interface for the disposable Peristaltic Pump Cartridge and one pneumatic output. The interface for the peristaltic pump cartridge ensures the peristaltic tubing is properly positioned for engagement by the pump head and the pressure sensor and integral pinch valves are properly aligned. The pneumatic connection delivers air pressure sufficient to drive a vitrectomy cutter. The Peristaltic Pump Cartridge will be provided as a sterile, single use product. The cartridge consists of a molded housing with pre-connected irrigation tubing which acts as a conduit for instilling balanced salt solution (BSS). The tubing interfaces with the rotating peristaltic roller pump head. In addition, the cartridge contains a pressure transducer that interfaces with the transducer PCB on the peristaltic module to measure the vacuum within the aspiration path of the cartridge.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Millennium™ Peristaltic Pump System, focusing on its description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a test set.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Information about training set size or how its ground truth was established.

The 510(k) process primarily assesses substantial equivalence to legally marketed predicate devices, rather than requiring extensive de novo clinical studies with predefined acceptance criteria for novel performance claims.

Ask a specific question about this device

The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. Delivery devices available are the Endoprobe for intraocular endolaser surgery, and the Laser Indirect Ophthalmoscope Plus (LIO+) for transpupillary laser delivery for patients in the supine position.

The Millennium™ Laser Photocoagulator System is a Class 4 laser. The system is made up of three separate components that are required to interface with each other in order to allow laser emission, They are the Laser Module, Multifunctional Foot Control with laser switch and the junction box. In order for the Millennium™ Microsurgical System to operate the Lascr Module, the system must have laser enabled software. The software includes functions to recognize the laser module as a network node and provides the graphical user interface.

The provided text is a 510(k) summary for the Millennium™ Laser Photocoagulator System. This document focuses on establishing substantial equivalence to a predicate device (IRIS Medical® OcuLight® GL Laser System) rather than presenting a performance study with acceptance criteria in the context of AI/ML or diagnostic devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not available in the provided text.

The document describes the device's components, intended use, and similarities/differences with the predicate device, ultimately receiving an FDA clearance based on substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative criteria through a clinical or technical study as might be done for novel diagnostic or AI-powered devices.

Ask a specific question about this device