(210 days)
The TRILEAP™ Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.
The TRILEAP Plating System is intended for reduction, temporary fixation, fusion and stabilization of bones. The system consists of a family of implantable devices consisting of 2.0mm, 2.5mm, 3.0mm, 3.5mm and 4.0mm non-contoured and anatomic procedure specific plates, cortical screws, and variable angle locking screws available in various sizes.
This document describes the FDA's clearance of the TRILEAP Plating System, a metallic bone fixation device. The focus of the provided text is on demonstrating the substantial equivalence of this new device to existing predicate devices through non-clinical performance data, rather than on a study proving the device meets acceptance criteria for an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment methods for an AI/ML device is not applicable to this submission.
The provided text only discusses non-clinical performance data for the TRILEAP Plating System as follows:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Plate Cross-Section Analysis (Bending Strength) | Not explicitly stated, implied to be comparable to predicate devices. | Not explicitly reported, implied to meet equivalence to predicates. |
| Screw Torsional Strength Analysis (ASTM F543 via FEA) | From FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)". | Not explicitly reported, implied to meet equivalence to predicates. |
| Screw Driving Torque (ASTM F543) | From FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)". | Not explicitly reported, implied to meet equivalence to predicates. |
| Screw Pull-Out (Chapman Equation) | Not explicitly stated, implied to be comparable to predicate devices. | Not explicitly reported, implied to meet equivalence to predicates. |
Summary of what's not in the document:
- Sample sized used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Explanation of the Study (as described in the document):
The study was a non-clinical performance evaluation conducted to demonstrate the substantial equivalence of the TRILEAP Plating System to predicate devices. The study involved:
- Non-clinical Performance Data: The following analyses were conducted:
- Plate Cross-Section Analysis (Bending Strength)
- Screw Torsional Strength Analysis according to ASTM F543 via a Finite Element Analysis model
- Screw Driving Torque according to ASTM F543
- Screw Pull-Out via the Chapman Equation
- Acceptance Criteria Source: Screw testing utilized acceptance criteria from the FDA Guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (December 2020)". For other tests, acceptance was implicitly based on demonstrating similarity or equivalence to the predicate devices.
- Conclusion: The results of the non-clinical performance data demonstrated that the subject devices are substantially equivalent to the predicate devices, and any differences in technological characteristics do not raise new questions of safety and effectiveness.
Clinical Performance Data: The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.