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Use of the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit 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 functions as an entire system that includes the following: Integra Camino Flex Ventricular Catheter Monitoring Kit (Catheter and Accessories) and Integra Camino Flex Adapter and Extension Cable), in which the Integra Camino Flex Adapter connects to the previously cleared Integra Camino Advanced Monitor (K962928 Integra LifeSciences Corporation) or to Integra Camino ICP Monitor (K121573 Integra LifeSciences Corporation).

The Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit 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 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 Ventricular Catheter in an MR environment is for conditional use in 1.5 Tesla (T) and 3.0 T MR Environments. The conditions for safe use are:

• · Not to exceed a maximum head or whole body averaged specific absorption rate (SAR) of 2 Watts/kg.
• · Not to exceed maximum scan duration of 15 minutes.
• · Circularly coil the externalized portions of the catheter within a 2.5 inch (6.3cm) to 3.5 inch (8.8cm) diameter range and securely tape it over the top of the patient's head.
• · Use only the following coils for MRI procedures:
  • o Transmit Body/Receive Body RF Coils
  • o Transmit Body Coils with any Receive-Only Coil (including receive-only head coils)
• · Do not use transmit head coils for MRI procedures
• · None of the catheter accessories, such as the trocar, stylet, drill stop and hex wrench should be brought into the MR environment. These accessories are only required during catheter placement and not needed in the MR environment.

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided text:

This submission (K133754) is a labeling modification to add MR safety information for the Integra™ Camino® Flex Ventricular Intracranial Pressure Monitoring Kit. Therefore, the "acceptance criteria" and "device performance" in this context refer to the device's compatibility and safety within an MR environment, not its primary function of ICP monitoring. The core functionality and performance related to ICP monitoring are assumed to be consistent with the predicate device as there are no changes to the product itself.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical tests" and "Magnetic Resonance testing only to demonstrate MR compatibility for the catheter." It does not specify a sample size for a test set that would typically involve human patients or clinical data. The testing appears to be entirely bench-top or laboratory-based to evaluate MR compatibility. Therefore, questions of country of origin or retrospective/prospective do not apply in the usual sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not provided in the document. Given that the study is a non-clinical, MR compatibility test for a labeling modification, the "ground truth" would be established by engineering and physics principles of MR safety and device integrity, rather than expert clinical interpretation of images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as this was not a study involving human readers or clinical data requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This study is not an MRMC comparative effectiveness study and does not involve AI assistance or human readers in that capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This study is not evaluating an algorithm or AI performance. It is evaluating the physical and electrical compatibility of a medical catheter with an MR environment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for this study is based on engineering and physics principles related to Magnetic Resonance (MR) safety and compatibility standards. This would involve measurements of induced heating, image artifact assessment, and force/torque assessments as per relevant MR safety standards (e.g., ASTM F2503). The document broadly states "Testing confirmed that the Integra 'Camino' Flex Ventricular Intracranial Pressure Monitoring Catheter is safe and effective for use in an MR environment under conditions specified in the product labeling."

8. The sample size for the training set

Not applicable. This study does not involve machine learning algorithms or a training set.

9. How the ground truth for the training set was established

Not applicable. This study does not involve machine learning algorithms or a training set.

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