(29 days)
The VariAx Elbow Plating System is intended for fracture fixation of long bones.
The distal humerus plates are indicated for:
• intra-articular or extraarticular fractures of the distal humerus
• osteotomies
• nonunions
The olecranon plates are indicated for:
• intra-articular or extraarticular fractures of the proximal ulna
• osteotomies
• nonunions
This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.
This submission is for a medical device, the VariAx Elbow Plating System, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.
Here's a breakdown of the provided information, focusing on the relevant sections for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in: | - Intended use |
| - Intended Use | - Design |
| - Design | - Materials |
| - Materials | - Operational principles |
| Mechanical performance as per ASTM F382-99 (reapproved 2008) "Standard Specification and Test Method for Metallic Bone Plates" | Testing demonstrated that the subject plates are substantially equivalent to the currently marketed predicate devices (VariAx Elbow Plating System K101056 and Synthes 3.5mm LCP Distal Humerus System K033995) in mechanical properties. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a non-clinical, mechanical testing study. The document refers to testing "worst case subject plates," implying a representative sample of each new plate type was tested.
- Data Provenance: The testing was "Non-clinical laboratory testing" performed by Stryker Trauma AG. The country of origin of the data is not specified but is presumably where Stryker Trauma AG conducts its R&D and testing. It is prospective testing designed to evaluate the new plates.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable to a non-clinical mechanical performance study. Ground truth is established by the ASTM F382-99 standard and the mechanical properties of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This was mechanical testing against a standard and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device for fracture fixation, not an AI/ML diagnostic or assistive tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. There is no algorithm for this device. The "standalone" performance here refers to the mechanical performance of the device itself. The study confirms that the device's mechanical properties (strength, fatigue, etc.) meet the specified standard and are equivalent to predicate devices.
7. Type of Ground Truth Used
The ground truth used for this device is based on:
- ASTM F382-99 (reapproved 2008) "Standard Specification and Test Method for Metallic Bone Plates": This standard defines the acceptable mechanical properties for bone plates.
- Performance of Legally Marketed Predicate Devices: Specifically, the VariAx Elbow Plating System (K101056) and the Synthes 3.5mm LCP Distal Humerus System (K033995) were used as benchmarks for substantial equivalence comparison.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/ML device and does not involve a "training set" in that context. The "training" in this case refers to the engineering design and manufacturing processes that result in the device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" ground truth in the context of an AI/ML device. The design and manufacturing of the device are based on established engineering principles, biomechanical understanding of bone fixation, and compliance with materials standards (e.g., ASTM F136 and ASTM F67 for titanium alloys).
§ 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.