(170 days)
The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.
The TriStar Bone Graft Fixation System consists of titanium alloy self-drilling screws which are tapered and have a maximum diameter of 1.75mm with lengths of 3mm, 4mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, and 24mm. The screws are manufactured using a Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes a number of accessories used to fixate the screws and/or membranes or bone blocks to the host bone including a square headed morse tapered hand screw driver, screw driver handle, and latch type driver. The system includes titanium mesh in 40mm x 60mm or 18mm x 25mm sizes each having a thickness of 0.1mm. The screws and titanium mesh are designed to be removed from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single use only.
This document describes the 510(k) premarket notification for the TriStar Bone Graft Fixation System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or provided in this type of regulatory submission.
Here's an analysis based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria with reported device performance values in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" for granting 510(k) clearance are related to demonstrating substantial equivalence to legally marketed predicate devices. This is achieved through comparisons of design, materials, indications for use, standards applied, and other characteristics.
The "reported device performance" is primarily qualitative, asserting that the device is substantially equivalent and raises no new safety or effectiveness concerns.
| Feature/Criterion (for Substantial Equivalence to Predicate) | TriStar Bone Graft Fixation System Performance (as reported for equivalence) |
|---|---|
| Screw Material | Ti-6Al-4V (ASTM F-136) - Equivalent to predicates |
| Screw Design | Self-Drilling - Similar to some predicates, different from others, but considered equivalent |
| Screw Length | 3mm - 24mm - Range falls within or is similar to predicates |
| Screw Diameter | 1.75mm max - Range falls within or is similar to predicates |
| Mesh Material | Grade 1 Titanium - Equivalent to predicate |
| Mesh Thickness | 0.1mm - Equivalent to predicate |
| Bench Testing - Screws | ASTM F-543 - Conforms to standard, also used for predicate |
| Bench Testing - Mesh | ASTM F-382 - Conforms to standard, also used for predicate |
| Biocompatibility | Tested under ISO 10993-5, found biocompatible - Consistent with regulatory requirements |
| Indications for Use | Stabilization and fixation of bone grafts, bone blocks, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity. - Equivalent to at least one predicate (Alpha-Bio Tec) and within the scope of others. |
The study that "proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which includes the results of non-clinical performance testing and a comparison to predicate devices to establish substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This document is for a medical device (bone graft fixation system), not a diagnostic AI/software device. The "test set" here refers to the device components themselves undergoing bench testing. The testing mentioned (ASTM F543-13 for screws and ASTM F382 for mesh) likely involved specific sample sizes as dictated by the standards, but these details are not provided in this summary.
- Data Provenance: Not applicable for a clinical study in this context, as "Clinical testing is not applicable to this device." The technical data comes from non-clinical laboratory bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of expert consensus is typically for diagnostic/AI evaluations. For this device, performance is evaluated against engineering standards and material specifications, not expert diagnostic assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is for clinical or diagnostic study design, not for mechanical device testing against engineering standards.
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 is a physical medical device, not an AI or software device that would assist human readers in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance in this context is defined by:
- Compliance with established international standards for metallic medical bone screws (ASTM F543-13) and mesh (ASTM F382).
- Compliance with biocompatibility standards (ISO 10993-5).
- Chemical composition of materials (e.g., Ti-6Al-4V (ASTM F-136)).
- Substantial equivalence to previously cleared predicate devices in terms of design, material, and indications for use.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model that undergoes "training."
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical medical device in this context.
§ 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.