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The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.

The Medtronic PS Medical Innervision Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter incorporates a BioGlide surface modification on the interior and exterior of the catheter. The catheter incorporates a slit tip.

This document is a 510(k) summary for the Medtronic PS Medical Innervision Ventricular Catheter with BioGlide. It is a premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA) based on substantial equivalence to predicate devices. As such, it does not describe a clinical study in the way a traditional clinical effectiveness study would for a novel device or drug.

Therefore, many of the typical acceptance criteria and study details (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with metrics like AUC or sensitivity/specificity, and training set details) are not applicable in this context.

Here's a breakdown of the available information in relation to your request:

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

The document describes the device's characteristics and compares them to predicate devices to establish "substantial equivalence." The "acceptance criteria" for a 510(k) submission are primarily about demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through a comparison of:

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

• Not Applicable. This is a 510(k) submission based on substantial equivalence to existing predicate devices, not a clinical trial with a "test set" of patients in the traditional sense. The "test" here is the comparison of the device's characteristics to those of already approved devices.

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

• Not Applicable. "Ground truth" in this context is the safety and effectiveness of the predicate devices, which have already been established by the FDA. The submission relies on the existing regulatory clearance of those devices.

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

• Not Applicable. There is no "test set" requiring adjudication in a clinical trial sense. The FDA's review process involves evaluation by regulatory experts.

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 device is a physical catheter, not an AI or imaging diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant.

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

• Not Applicable. As above, this is a physical medical device, not an algorithm.

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

• The "ground truth" for this type of submission is the established safety and efficacy profiles of the predicate devices as previously determined by the FDA. The new device is asserted to be "substantially equivalent" to these already cleared devices, meaning it does not raise new questions of safety and effectiveness.

8. The sample size for the training set:

• Not Applicable. There is no "training set" for a device like this in the context of a 510(k). The device's design and materials are based on established engineering principles and prior device experience, not machine learning training data.

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

• Not Applicable. See point 8.

In summary:

This document is a regulatory submission for device clearance, not a report of a clinical efficacy study. The "study" proving the device met acceptance criteria is the comparison presented in the document itself, demonstrating that the Innervision Ventricular Catheter with BioGlide shares the same technological characteristics, intended use, and therefore the same safety and effectiveness as its predicate devices, which were already cleared by the FDA.

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