(201 days)
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
The Neo Titanium mesh and CTi-mem are meshes and membranes intended to be used for stabilizing and supporting bone grafts in dento-alveolar bony defect sites. The devices are fabricated from Grade 2 Titanium (ASTM F-67) and supplied in various sizes and shapes, non-coated, sterile, for single-use and disposable. The membranes are shaped and/or trimmed by the user for the intended target shape. The Neo Titanium mesh is the common shape of the membrane. The Cti-mem series are customized titanium membranes allowing minimum cutting and bending for attaching to the location of the part used.
This 510(k) summary describes a medical device, Neo Titanium mesh and CTi-mem, which are titanium meshes and membranes used for stabilizing and supporting bone grafts in dento-alveolar bony defect sites. The submission aims to demonstrate substantial equivalence to a predicate device, the Osteo-Mesh TM-300 (K984230).
1. Table of Acceptance Criteria and Reported Device Performance
This submission does not provide explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or functional thresholds as would be common for AI/software devices. Instead, it relies on demonstrating substantial equivalence to a predicate device based on material, design, and intended use. The "performance" reported here is the result of non-clinical testing and comparison.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Neo Titanium mesh, CTi-mem) |
|---|---|
| Material Composition Equivalence | |
| (Must be made of safe, biocompatible material suitable for implant) | Fabricated from Grade 2 Titanium (ASTM F-67), which has established biocompatibility through long history of use in implantable medical devices. |
| Intended Use Equivalence | |
| (Same indications for use as predicate) | For stabilization and support of bone grafts in dento-alveolar bony defect sites, same as the predicate device. |
| Design/Functional Equivalence | |
| (Similar function and general characteristics) | Meshes and membranes intended for stabilizing and supporting bone grafts. Has the "same device characteristics, composition, function, and intended use as the predicate device." |
| Non-Clinical Safety & Performance | |
| (Demonstrate basic functionality and safety) | Performance testing included visual, dimension, packaging, and package seal efficacy testing. Biocompatibility established by material history. |
| Substantial Equivalence Conclusion | |
| (Overall safety and effectiveness compared to predicate) | Concludes that the Neo Titanium mesh and CTi-mem are safe, effective, perform at least as well, and are substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This submission pertains to a physical medical device (titanium mesh/membrane), not a software device or AI algorithm that relies on a "test set" of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable to this type of device submission.
The "testing" involved non-clinical performance evaluations like visual inspection, dimensional checks, and packaging integrity tests. The "samples" for these tests would be units of the manufactured device. No human patient data was used or analyzed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as the device is a physical implant and its evaluation does not involve diagnostic interpretation or AI algorithm performance on clinical data where ground truth would be established by experts.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3.
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
This is not applicable. This is a submission for a physical medical device, not an AI or software-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
This is not applicable as no diagnostic or predictive algorithm requiring a ground truth was evaluated. The "truth" for this device's performance relies on established material properties (Grade 2 Titanium), accepted manufacturing standards, and comparison to an already cleared predicate device.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 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.