Search Results

Statement of indications for use:
The Caroline Guide is indicated for use by neurosurgeons for posterior ventricular catheter placement for patients who are:

Adults or children
Have enlarged ventricles
Have no intracranial mass legions or any structural abnormalities other than hydrocephalus
Have no general contraindications to surgery

Device Description

The Caroline Guide is a mechanical device that helps the surgeon orient a ventricular catheter along a straight line connecting the posterior burr hole entrance point and a frontal target point.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Accuracy: Maintain alignment of the ventricular catheter with the frontal target point as it is advanced through the guide tube.	Met: "The mechanical accuracy of the Caroline Guide was tested in non-clinical studies by passing ventricular catheters through the guide tube and confirming that the catheters maintain alignment with the frontal target point as they were advanced by hand."
Material Durability: Withstand repeated decontamination, cleaning, and sterilization cycles without adverse effects.	Met: "Pre-clinical testing demonstrated that the materials used in the construction of the Caroline Guide will withstand repeated decontamination, cleaning and sterilization cycles without adverse effects."
Safety and Effectiveness in Pediatric Patients: No complications when used in pediatric patients.	Met: "No complications have been noted as a result of use of the Caroline Guide in pediatric patients."
Safety and Effectiveness (Overall): New technologic features do not adversely affect safety or effectiveness in a way that is consequential under the conditions of intended use.	Met: "These pre-clinical and clinical test data indicate that the new technologic features of the modified Caroline Guide do not adversely affect safety or effectiveness in a way that is consequential under the conditions of intended use."

Study Information

Here's the detailed study information based on the provided text, noting that the document primarily describes pre-clinical (non-clinical) and clinical test data from a previous study rather than a new de novo study for this specific submission:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size.
- Data Provenance: The clinical trial "involved both pediatric and adult patients" at the Universities of Iowa and Washington. Non-commercial prototypes were also "used routinely in adult and pediatric cases" at these universities and Children's Hospital, Washington University (St. Louis). This suggests a retrospective analysis of previously collected data and ongoing experience, rather than a new prospective trial for this specific K98/809 submission. The countries of origin are the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The text mentions "neurosurgeons" as the intended users and participants in the clinical use, but doesn't detail their specific role in establishing "ground truth" for the assessment of device performance from the earlier referenced trials.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated.
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:
- No. This device is a mechanical guide, not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for mechanical aspects. The "non-clinical tests" evaluated the device's mechanical accuracy (maintaining alignment) and material durability in a standalone manner, without human intervention during the actual "test" phase for these specific criteria.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes/Observation: For the clinical aspect, ground truth was based on the absence of complications in pediatric patients during actual use and the overall safety and effectiveness observed in the referenced clinical trial and subsequent routine use.
- Direct Measurement/Observation: For mechanical accuracy, it involved confirming catheter alignment. For material durability, it involved observing the material's condition after cleaning/sterilization cycles.
The sample size for the training set:
- Not applicable/Not explicitly stated. This is a mechanical device, not a machine learning algorithm requiring a "training set" in the conventional sense. The "training" essentially occurred through the previous design, testing, and clinical use of commercial and prototype versions of the device.
How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, the concept of establishing ground truth for a "training set" does not apply. The functional requirements and design were likely based on neurosurgical principles and previous device experience.

Ask a Question

Ask a specific question about this device

Page 1 of 1