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Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.

The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter (Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Camino Advanced Monitor (510(k) K962928 Integra LifeSciences Corporation).

The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Integra Camino Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required. The device is a single use, disposable product. The device is comprised of a highly flexible catheter with a tensile member, a pressure sensing tip, an electrical connection to a monitor, and a drainage lumen to allow fluid connection to an extraventricular drainage (EVD) device. The device is designed for the tunneling surgical method and the kit includes the necessary accessories for access and implantation of the catheter. The following Accessories are referenced in 510(k) K904883: Drill, Drill Stop, Set Screw, Hex Wrench, Trocar, Trocar Sheath, Suture Loops, and Male Luer Cap.

The tip of the Integra Camino Flex Ventricular Catheter is implanted within the anterior horn of the left or right lateral cerebral ventricle. A cylindrical volume with a height of at least 11 mm and a diameter of at least 5 mm are required for catheter implantation.

The Integra Camino Flex Adapter performs the functions of receiving the transducer signal from the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter, amplifying the signal, and transmitting the signal to the Camino® Advanced Monitor. The Integra Camino Flex Adapter converts the signals produced by the Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit catheter sensor. This signal is sent to the Adapter by means of the extension cable to the Camino® Advanced Monitor.

The Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra™ Camino® Flex Adapter is a medical device. The provided text describes the device and its intended use but does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is a 510(k) summary for regulatory clearance, focusing on substantial equivalence to predicate devices, sterilization, and general device description.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case study information, standalone performance, or training set details from the provided text. This information would typically be found in a detailed validation or clinical study report, which is not present here.

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