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510(k) Data Aggregation
(42 days)
CSF Shunt components are designed to provide controlled Cerebrospinal Fluid (CSF) flow from the ventricles of the brain to the right atrium of the heart or the peritoneal cavity.
The PS Medical Neurosurgical Implants are manufactured with silicone adhesive. The devices are used as shunt components.
This document concerns a 510(k) submission for Medtronic PS Medical® Neurosurgical implants, specifically CSF Shunt components. It is a traditional 510(k) submission, intended to demonstrate substantial equivalence to previously cleared devices rather than providing a de novo study with strict acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) submission.
Here's why and what can be inferred:
- Substantial Equivalence: The core of a 510(k) submission for devices like this is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar materials, intended use, performance characteristics, and design specifications. It does not usually involve extensive new clinical trials or performance studies with predefined acceptance criteria in the way a novel device or a device requiring a PMA (Premarket Approval) would.
- Focus on Predicate Device: The submission explicitly states: "Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the CSF-Flow Control Shunt components are equivalent to the previously reviewed and cleared products. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the products based upon the predicate and currently marketed devices."
- Lack of Performance Data: The provided text does not include any performance data, clinical trial results, or study methodologies that would address the questions posed.
Summary based on available information:
| Information Category | Detail from Submission |
|---|---|
| Acceptance Criteria & Reported Device Performance | Not provided. The submission focuses on substantial equivalence to predicate devices based on materials, intended use, performance characteristics, and design specifications. There are no explicitly stated acceptance criteria or reported device performance metrics from a new study presented in this document. |
| Sample Size (Test Set) & Data Provenance | Not applicable/Not provided. This type of 510(k) submission does not typically involve a new "test set" in the context of a performance study with human-interpreted data. The comparison is against predicate devices and their established safety and efficacy profiles. |
| Number of Experts & Qualifications (Ground Truth) | Not applicable/Not provided. No new ground truth establishment study is described. Substantial equivalence relies on the established safety and efficacy of the predicate devices. |
| Adjudication Method | Not applicable/Not provided. No new ground truth establishment study is described. |
| MRMC Comparative Effectiveness Study | No. This type of device (physical shunt components) does not involve AI or image interpretation where an MRMC study would be relevant. |
| Standalone Performance Study (Algorithm Only) | No. This device is a physical medical implant, not a software algorithm. |
| Type of Ground Truth Used | Not applicable/Not provided. The "ground truth" implicitly relies on the historical clinical performance and regulatory clearances of the predicate CSF shunt devices. |
| Sample Size for Training Set | Not applicable/Not provided. No machine learning or AI model training is involved. |
| How Ground Truth for Training Set was Established | Not applicable/Not provided. No machine learning or AI model training is involved. |
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