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The Codman Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

The Codman Certas Tool Kit allows the noninvasive reading or adjustment of the valve setting.

The Codman Certas Plus Programmable Valve is a sterile, single use, implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The Codman Certas Plus Programmable Valves are pressure-regulating valves utilizing the ruby ball-in-cone principle with a pressure inducing spring design. Intraventricular pressure is maintained by the ball and cone valve seat design. As the differential pressure across the shunt increases, the ball further displaces from the cone, through which CSF flows, thereby increasing flow and re-establishing the selected pressure. The ball is manufactured of synthetic ruby, as is the matching cone. Together these components provide a precise fit for regulating the flow of CSF through the valve.

The valve is available with 8 different performance settings for constant intraventricular pressure and drainage of CSF. Seven (7) of the settings provide for a change in operating pressure, with a range of 25 to 215 mmH2O. The eighth setting provides a minimum opening pressure of '400' mmH20, thus allowing a physician to turn the valve “virtually off” without the need to surgically remove the valve to limit flow. The pressure of the valve is set preoperatively and can be noninvasively changed post-implantation by using the Codman Certas Tool Kit, which employs magnetic force to select one of the 8 settings.

The provided text does not contain information related to the acceptance criteria and study details for an AI/ML-based device. The document is a 510(k) premarket notification for a medical device (Codman Certas Plus Programmable Valve and Codman Certas Tool Kit), which is a physical implantable device and its accompanying tool kit, not a software or AI/ML algorithm.

Therefore, the specific questions regarding AI/ML performance metrics, sample sizes for AI/ML models, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

The document discusses various forms of bench testing, MRI testing, and biocompatibility testing for the physical device, and states that no animal or clinical studies were required due to the device's similarity to a predicate device and successful bench testing.

There is no information in the provided text that allows for the completion of the requested table and answers related to AI/ML device criteria.

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