(96 days)
The Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
The Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.
Screws
The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self-drilling tips. Screws are manufactured from titanium alloy (Ti 6Al 7Nb).
Plates and Meshes
The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium.
This document is a 510(k) Summary for the Synthes Dentoalveolar Bone Fixation System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are focused on demonstrating "substantial equivalence" to predicate devices through non-clinical mechanical testing, rather than specific performance metrics directly tied to clinical outcomes. The performance is assessed comparatively.
| Acceptance Criteria (Defined by Comparison to Predicate Devices) | Reported Device Performance |
|---|---|
| Screws (vs. predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System screws): | |
| * Resistance to axial pullout equivalent or better | Performed mechanical testing to measure resistance to axial pullout. |
| * Shear strength equivalent or better | Performed mechanical testing to measure shear strength. |
| * Safety factor during insertion (ratio of failure torque to insertion torque) equivalent or better | Performed mechanical testing to measure safety factor during insertion. |
| Plates (vs. predicate Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System plates): | |
| * Load at 0.2% offset yield equivalent or better | Performed mechanical testing to measure load at 0.2% offset yield. |
| * Bending strength equivalent or better | Performed mechanical testing to measure bending strength. |
| Mesh (vs. predicate Osteo-Mesh TM-300): | |
| * Peak load equivalent or better | Performed mechanical testing to measure peak load. |
| * Displacement at peak equivalent or better | Performed mechanical testing to measure displacement at peak. |
| * Load at 0.2% offset yield equivalent or better | Performed mechanical testing to measure load at 0.2% offset yield. |
| * Bending stiffness equivalent or better | Performed mechanical testing to measure bending stiffness. |
| * Bending strength equivalent or better | Performed mechanical testing to measure bending strength. |
| Overall Conclusion: | The results of the non-clinical testing demonstrate that the mechanical performance of the Synthes Dentoalveolar Bone Fixation System devices is equivalent to or better than the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of screws, plates, or mesh samples) used for each mechanical test. It only states that "Mechanical testing was performed."
- Data Provenance: The data is from non-clinical testing, meaning it was conducted in a laboratory setting. There is no information provided about the country of origin. This is not retrospective or prospective in the clinical sense, as it’s bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies solely on non-clinical mechanical testing, not expert-established ground truth from clinical or imaging data. Therefore, no experts were involved in establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As this is mechanical testing, there is no need for an adjudication method for human interpretation or consensus. The "ground truth" is determined by the physical properties measured in the lab.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical testing was performed to support this submission." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical implant (bone plates and screws), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on objective mechanical property measurements obtained through non-clinical laboratory testing. This includes measurements like resistance to axial pullout, shear strength, load at yield, bending strength, peak load, and bending stiffness. The "truth" is the measured physical performance.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for physical components. The design and manufacturing processes are likely informed by engineering principles and standards, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The mechanical properties are inherent to the material and design, and are validated through testing against established engineering standards and predicate device performance.
§ 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.