(76 days)
Micro Dynamic Mesh is intended to stabilize fractures, grafts and elective osteotomies for the reconstruction of the bones of the craniomaxillofacial skeleton, and the oral cavity (including the mandible and maxilla).
The Leibinger® Micro Dynamic Mesh is a titanium mesh available in different shapes, thicknesses, and perforation patterns to treat a variety of clinical applications. The material can be cut with scissors for precision fit, is malleable for three-dimensional adaptations, and is perforated to permit fluid exchange. The mesh is attached to bone by screws. The titanium construction allows for radiological identification but produces negligible artifacts on CT or MRI.
The provided text is a 510(k) summary for the Micro Dynamic Mesh, a titanium mesh used for craniomaxillofacial skeletal reconstruction. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria or performance metrics for the Micro Dynamic Mesh. Instead, it relies on demonstrating substantial equivalence to already marketed predicate devices. This means the device is considered acceptable if its intended use, materials, design, and operational principles are equivalent to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document beyond substantial equivalence to predicates. | Not specified in the document beyond substantial equivalence to predicates. |
2. Sample size used for the test set and the data provenance
No specific test set or clinical study data is provided in this 510(k) summary. The demonstration of substantial equivalence typically relies on comparative analysis with predicate devices and possibly bench testing, but not clinical trials with sample sizes for performance evaluation in the way requested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth establishment for performance evaluation is described.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
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 titanium mesh, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical titanium mesh, not an algorithm.
7. The type of ground truth used
Not applicable in the context of a performance study for this type of device. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate devices. The new device aims to be "substantially equivalent" to those.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.