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The Caroline Guide is intended for use by neurosurgeons during posterior ventricular catheter placement procedures.

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

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

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.

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

Acceptance Criteria and Device Performance

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:

1. 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.

2. 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.

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

   • Not explicitly stated.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Delia Localizer and Caroline Guide are indicated for use by neurosurgeons as shunt accessories for patients scheduled to undergo a posterior ventricular catheter placement procedure who are: 1) Adults 2) Have enlarged ventricles 3) Have normal scalp, skull, external ear and orbital anatomy 4) Do not have intracranial mass lesions or any structural abnormalities other than hydrocephalus 5) Have no general contraindications to surgery

The Delia Localizer is a head-band based apparatus that aids the surgeon in identifying the optimal location for placing a posterior burr hole for purposes of inserting a posterior ventricular catheter. It mechanically reduces to practice geometric principles that are already used to manually calculate where to position a posterior burr hole. 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 the frontal target point.

The provided text describes a 510(k) summary for the "Caroline Guide and Delia Localizer" integrated system. However, it does not explicitly state specific numerical acceptance criteria or detail a study designed to prove the device meets these criteria in the typical quantitative manner we might expect for medical device performance evaluation.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device (a ventricular catheter stylette).
• Technological Characteristics: It highlights similarities in indications for use, method for advancing the catheter, and patient exposure to materials, while describing how the new device mechanically simplifies existing manual techniques.
• Pre-clinical Testing: This testing focused on confirming geometric principles and mechanical accuracy.
• Clinical Testing: A clinical trial of the Caroline Guide alone was reported in peer-reviewed literature. More recently, a clinical trial of the combined Delia Localizer and Caroline Guide system was approved, and clinical data on its performance was "now available."

Given this, I will reconstruct the "acceptance criteria" and "study" information based on the emphasis of the 510(k) process, which prioritizes safety and effectiveness demonstrated through substantial equivalence rather than explicit quantitative performance metrics like sensitivity/specificity often seen in AI/diagnostic device submissions.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this 510(k) notice is primarily framed around the demonstration of substantial equivalence to a predicate device, and ensuring the new technological features do not adversely affect safety or effectiveness. Specific quantitative performance metrics are not provided as acceptance criteria.

Study Details

The text describes both non-clinical and clinical tests. The primary "study" proving the device meets the substantial equivalence criteria encompasses these findings.

2. Sample size used for the test set and the data provenance:

• Delia Localizer (Pre-clinical):
  • Test Set: Head CT scans of patients with hydrocephalus (number not specified).
  • Provenance: Not explicitly stated, but implies clinical data from patients with hydrocephalus. The cranial phantoms used were for "differing head sizes."
• Caroline Guide (Non-clinical):
  • Test Set: Not a human sample size, but involved testing with ventricular catheters and the guide tube.
• Caroline Guide (Clinical - standalone):
  • Test Set: Not explicitly stated, but a clinical trial was conducted at the Universities of Iowa and Washington. This trial was reported in peer-reviewed literature in 1995. This would be prospective data given it was a trial.
• Delia Localizer + Caroline Guide (Clinical - combined system):
  • Test Set: Clinical data (number of patients not specified) from a new clinical trial approved by the University of Iowa Institutional Review Board. This would be prospective data.
  • Provenance: University of Iowa.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For the pre-clinical analysis of CT scans, "anatomical analysis" was performed, which implies expert involvement, but the number and qualifications of experts are not specified.
• For the clinical trials, it is implied that neurosurgeons were involved in using and evaluating the device, but their number and specific qualifications for establishing 'ground truth' or evaluating outcomes are not detailed in this summary.

4. Adjudication method for the test set:

• Not specified. The 510(k) summary does not provide details on adjudication methods for either the pre-clinical or clinical studies.

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:

• No, an MRMC study was not done. This device is a mechanical surgical guide, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply. The comparison is between manual surgical techniques and mechanically guided techniques. The summary states that the new device "mechanically reduces to practice geometric principles that are already used to manually calculate."

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

• Yes, in essence. The pre-clinical tests for the Delia Localizer (validity of geometric principles, accuracy on phantoms) and the non-clinical tests for the Caroline Guide (mechanical accuracy with catheters) can be considered "standalone" evaluations of the device's mechanical function, prior to or separate from human-in-the-loop clinical use.

7. The type of ground truth used:

• Delia Localizer (Pre-clinical): Established geometric principles related to burr hole placement, confirmed by "anatomical analysis of head CT scans" and testing against physical cranial phantoms.
• Caroline Guide (Non-clinical): Mechanical alignment with a "frontal target point."
• Clinical Trials (Caroline Guide alone and combined system): Clinical performance, which for a surgical guidance device typically involves outcomes like successful catheter placement, reduction in complications, accuracy of placement, and patient safety. The specific metrics are not detailed but would be expert-assessed clinical outcomes.

8. The sample size for the training set:

• Not applicable in the typical sense of machine learning. This device is mechanical, not an AI/ML algorithm that requires a "training set." The development of the device would have been基于engineering principles and anatomical knowledge rather than data training.

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

• Not applicable as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design principles was established through anatomical and geometric understanding, surgical practice, and pre-clinical verification.

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