(88 days)
The EDM Ventricular Catheters with BioGlide are designed for use as the proximal component for cerebrospinal fluid (CSF) drainage and/or monitoring from the lateral ventricles of the brain.
The Medtronic PS Medical EDM Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter is provided in two sizes and incorporates a BioGlide surface modification on the interior and exterior of the catheter.
The provided document is a 510(k) summary for the Medtronic PS Medical External Drainage and Monitoring (EDM) Ventricular Catheter with BioGlide. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, the requested information elements related to acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not contained within this document. This document is a regulatory submission for premarket notification, designed to show equivalence based on material, intended use, and design specifications, not to detail a performance study against specific acceptance metrics.
However, I can extract information related to the device's characteristics and its comparison to predicate devices, which indirectly speaks to its "performance" in the context of substantial equivalence.
Here's a summary of the information that can be extracted from the provided text, along with an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance
This document describes a comparison to predicate devices to establish substantial equivalence. It does not present specific quantitative acceptance criteria or a formal study with reported device performance against those criteria. The "performance" assessment here is qualitative, based on similarity to already approved devices.
| Feature | Acceptance/Comparison Criteria (Implied) | Reported Device Performance (as listed for the new device) |
|---|---|---|
| Materials | Substantially equivalent to predicate devices (Silicone elastomer). | Silicone elastomer, w/barium impregnated stripe, BioGlide surface modification. |
| Dimensions | Within range or substantially equivalent to predicate devices (1-4mm Dia., 20-40cm Length). | Diameter 1-3mm, Length 20-40cm. |
| Sterility Method | EtO as used by predicate devices (or a recognized method). | EtO. |
| Sterile Status | Sterile single-use device. | Sterile single-use device. |
| Intended Use | Substantially equivalent to predicate devices (CSF drainage/monitoring). | As the proximal component for draining and monitoring of CSF flow from the lateral ventricles of the brain. |
| General | Substantial equivalence in materials, intended uses, performance characteristics, and design specifications. | Claimed substantial equivalence, safety, and efficacy based on predicate and currently marketed devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is a 510(k) premarket notification, which relies on comparison to predicate devices rather than a de novo clinical trial or extensive test set performance data.
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 information is not provided. Ground truth establishment and expert review in the context of a performance study are not detailed because such a study is not presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies comparing device output to expert consensus, which is not the focus of this 510(k) submission.
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
A MRMC comparative effectiveness study is not mentioned and is not applicable to this type of device (a ventricular catheter). This is a purely physical medical device, not an AI or imaging-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical ventricular catheter and does not involve an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Ground truth is not discussed in this document as it's not a study on diagnostic accuracy or clinical outcomes in the typical sense. The "ground truth" for this 510(k) is the established performance and safety of the predicate devices.
8. The sample size for the training set
This information is not applicable as the device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).