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The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.

The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system.

This document is a 510(k) summary for the Stryker® Leibinger Universal Neuro System, a medical device for craniofacial fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested items related to a study design and performance metrics cannot be found in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or a table reporting device performance against such criteria are provided in the document. The submission is a 510(k) premarket notification, which primarily seeks to establish substantial equivalence to existing legally marketed devices, rather than performing a de novo effectiveness study with pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a clinical or performance test set with a sample size. The substantial equivalence argument relies on comparison to predicate devices, not data from a new test set.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. Ground truth establishment by experts is relevant for studies where a new device's output is compared to a diagnostic or measurement standard. This 510(k) focuses on mechanical properties and intended use comparison.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned or implied because this is a mechanical fixation system, not a diagnostic imaging or AI-assisted system.

6. Standalone Performance Study (Algorithm Only)

No. This is a system of physical plates and screws, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The concept of "ground truth" as typically applied to diagnostic or AI studies is not relevant here. The evidence for substantial equivalence would likely involve bench testing of mechanical properties (e.g., strength, fatigue) and material biocompatibility, comparing them to the predicate devices. These specific tests and their results are not detailed in this summary.

8. Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary of Device Comparison and Substantial Equivalence:

The core of this 510(k) submission is to demonstrate substantial equivalence to existing devices, specifically:

• K022185 Universal CMF System
• K924138 Osteomed M 3 System
• K023260 Osteomed 1.2 mm Autodrive Screw System
• K022012 Synthes Low Profile Neuro System

The argument for substantial equivalence is based on the device's intended use (osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas), which is consistent with the predicate devices. The "low-profile plate and screw system" description also implies similar design and mechanism of action to the predicates. The FDA's letter (K031659) confirms that they reviewed the submission and determined the device to be substantially equivalent for the stated indications for use. This means the FDA concluded that the new device is as safe and effective as the legally marketed predicate devices, and does not raise different questions of safety and effectiveness.

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