(326 days)
The TriMed Radiocarpal Fusion System plates and screws are intended for wrist arthrodesis and fixation of fractures of other small bones.
TriMed Radiocarpal Fusion plates are designed to provide total immobilization of the wrist during wrist arthrodesis and for fixation of fractures of other small bones. The TriMed Radiocarpal Fusion System comprises of bone plates and screws. All plates and screws are similar to predicate devices. TriMed Radiocarpal Fusion plates come in a variety of lengths, bend angles, and screw mating configurations. All plates are designed to accommodate locking and non-locking screws. TriMed cortical bone screws for the wrist fusion application are available in diameters of 2.7 mm and 3.2 mm. All screws come in a variety of lengths and plate locking conditions. The Radiocarpal Fusion plates and screws are made of either ASTM F138/139 implant grade stainless steel or ASTM F136 implant grade Titanium alloy.
This document describes the TriMed Radiocarpal Fusion System, a device for wrist arthrodesis and fixation of fractures of other small bones.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Verification of safety and functionality through theoretical calculations and mechanical tests (static bending loads). | Results demonstrate that the physical properties of the TriMed Radiocarpal Fusion Plating System are substantially equivalent to the predicated devices. |
| The new product does not change the intended use or scientific principles used for safe and effective implantation of the device compared to predicate devices. | The new product does not change the intended use or scientific principles used for safe and effective implantation of the device. |
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical data or patient cases. The evaluation appears to be based on theoretical calculations and mechanical testing.
- Data Provenance: The data provenance is not applicable as the evaluation primarily relies on theoretical calculations and mechanical tests rather than patient-specific data from a particular country or source.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study relies on engineering principles (theoretical calculations and mechanical testing) rather than expert-established ground truth from clinical cases. There is no mention of experts being used in this capacity.
4. Adjudication method for the test set:
Not applicable. The evaluation involves mechanical testing and theoretical calculations, not clinical adjudication.
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 medical implant (radiocarpal fusion system), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical implant, not an algorithm, so the concept of standalone algorithmic performance is irrelevant.
7. The type of ground truth used:
The "ground truth" for this device's evaluation is based on established engineering and biomechanical principles verified through theoretical calculations and mechanical tests. The acceptance criteria are met when these tests demonstrate substantial equivalence to predicate devices, indicating that the device performs safely and effectively as expected for its intended use.
8. The sample size for the training set:
Not applicable. This device's evaluation does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.