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The OSV II® Low Flow Low Pro Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) and the currently marketed Integra NPH Low Flow Valve System (NPH Valve) are implantable hydrocephalus valve systems for shunting controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, these valves are variable resistance valves which maintain a drainage rate constant within the physiological range for the specified populations and disorders of intracranial pressure. These valves were designed to maintain a lower drainage rate than that of normal CSF production (approximately 20 ml/hr), and are intended to accommodate the needs of patients requiring a drainage rate between 8-17 ml/hr. The proposed OSV II LFLP Valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate the needs of patients requiring a smaller valve.

The proposed OSV II Low Flow Low Pro Valve (OSV II LFLP) is similar to the currently marketed Integra NPH Low Flow Valve. The proposed valve is designed to maintain the same lower drainage rate of 8-17 ml/hr, but with a smaller overall height and diameter to accommodate patients requiring a smaller valve. The modifications include a reduction in the silicone boot (external envelope) and replacement of the needle stop.

The proposed OSV II LFLP Valve System is available in different configurations in order to accommodate the needs of the patient. A system typically consists of a valve unit, a ventricular (proximal) catheter, and a drainage (distal) catheter. Depending on the configuration, the ventricular catheter is fully radiopaque length markings at 2cm intervals from the tip, or, with a barium stripe and non radiopaque length markers every 1cm. Connectors are designed for use with 1.1 to 1.4 mm inner diameter silicone elastomer tubing.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (OSV II® Low Flow Low Pro Valve) seeking substantial equivalence to a predicate device. It describes the device, its indications for use, and a comparison to predicate devices, but it does not include any performance data, clinical study results, or specific acceptance criteria for performance metrics.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement. The document primarily focuses on establishing substantial equivalence based on design and material similarities to previously cleared devices.

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