(83 days)
The TriMed Sidewinder and Cluster Plates are indicated for fractures, non-unions & osteotomies of the distal fibula.
The TriMed Straight Plates and Ankle Hook Plates are indicated for fractures, non-unions & osteotomies of the distal fibula and distal tibia.
The TriMed Medial Malleolar Sleds and 4.0 Cannulated Compression Screws are indicated for fractures, non-unions & osteotomies of the Medial Malleolus of the distal tibia.
TriMed Ankle Fixation System (AFS) is a comprehensive ankle fracture fixation system intended to aid the treatment of certain types of fractures, malunions, and non-union of the tibia and fibula. The system is designed to constraint movement between bone surfaces and is intended only as an aid to fix the fracture in place during the healing process.
The system implants consist of plates, screws and wire form devices and supporting instrumentation. The implants vary in designs, and sizes to accommodate patient size, anatomy and fracture type. The implants manufactured from 316L medical grade stainless steel per ASTM F138 or F139.
Here's a breakdown of the acceptance criteria and study information for the TriMed Ankle Fixation System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA's letter (K243999) on the TriMed Ankle Fixation System indicates that the device's performance was evaluated against established standards and guidance documents. The acceptance criteria are implicitly defined by these standards, with the reported performance being that the device met or exceeded them.
| Acceptance Criteria (Defined by Standard/Guidance) | Reported Device Performance |
|---|---|
| Mechanical Performance (Screws): ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) and FDA Guidance (Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway) | Performed equivalent or better in comparison to the predicate device. |
| Mechanical Performance (Plates): ASTM F382 (Standard Specification and Test Method for Metallic Bone Plates) | Performed equivalent or better in comparison to the predicate device. |
Regarding the Predetermined Change Control Plan (PCCP) specifically for combining the Medial Malleolar Sled and Washer:
| Acceptance Criteria (Planned Modification) | Reported Device Performance |
|---|---|
| Biocompatibility and Sterilization: To meet the same requirements as set for the original TriMed Ankle Fixation System. | The document states these will be conducted to the same requirements, implying they will meet these requirements upon implementation of the change. |
| Mechanical Performance (Combined Sled and Washer): Construct Static bend and endurance bend testing (per Medial Malleolar Sled Static and Endurance Test Plan Rev 1.0) will be performed to verify the mechanical performance for fracture fixation. | The document states these tests will be performed to verify mechanical performance, implying they are the acceptance criteria for this specific change. The actual performance data is not yet available as this is a future planned modification. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the mechanical testing mentioned (ASTM F543-17, FDA Guidance, ASTM F382). These standards typically define sample size requirements. The data provenance is implied to be from TriMed, Inc.'s internal testing, as it's a premarket notification for their device. No specific country of origin for the data is mentioned, but the submitter is based in Santa Clarita, California, USA. The studies are retrospective in the sense that they were conducted to support the 510(k) submission for an existing device or a planned modification.
3. Number of Experts and Qualifications for Ground Truth
This document describes pre-market device clearance based on mechanical testing and equivalence to predicate devices, not on diagnostic performance where expert ground truth establishment would be relevant. Therefore, there are no experts referenced for establishing ground truth as this is primarily a hardware/material performance evaluation.
4. Adjudication Method for Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation (e.g., image-based diagnostics) to establish a consensus ground truth. This submission focuses on the mechanical and material properties of a surgical implant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the impact of AI systems on human readers' diagnostic performance. This document concerns a physical medical device (ankle fixation system) and its mechanical performance, not an AI or diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No. This is not an algorithm or software device.
7. Type of Ground Truth Used
The "ground truth" for the TriMed Ankle Fixation System's mechanical performance is defined by the standards and guidance documents (e.g., ASTM F543-17, ASTM F382) that specify acceptable mechanical properties and testing methodologies. The device's performance is then compared to these established benchmarks and to predicate devices rather than clinical outcomes or pathology reports in the context of this 510(k) summary. For the Predetermined Change Control Plan, the ground truth for performance verification will be the results of the specified static bend and endurance bend testing.
8. Sample Size for the Training Set
Not applicable. There is no AI/machine learning component involved that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.