(85 days)
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
- osteotomies, mal-unions, and non-unions .
- single, segmental, and comminuted fractures .
- normal bone density and osteopenic bone .
The VariAx 2 Compression Plating System is an internal fixation device that consists of various plates used with compatible screws to fit different types of fractures in the radius, ulna, humerus, clavicle, distal tibia and fibula. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 30-246mm in length.
This document describes a 510(k) submission for the VariAx 2 Compression Plating System, a medical device for internal fixation of bone fractures.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device must be substantially equivalent to the predicate device (K130009) in intended use, materials, and performance characteristics. | Non-clinical testing demonstrated that the modified plates are substantially equivalent to the previously cleared K130009. |
| Mechanical Performance | (Implied) The modified plates must maintain adequate mechanical strength and stability. | Testing was performed for "Compression Plates Screw Through Compression Hole 0° and 15° Angulation with VariAx Screws." The results supported substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load, displacement) and their corresponding performance values are not explicitly stated in this document. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Non-clinical laboratory testing" and "The following testing was performed: - Compression Plates Screw Through Compression Hole 0° and 15° Angulation with VariAx Screws." This implies physical testing of device samples rather than a data-driven test set for an algorithm. The number of physical units tested is not provided.
- Data Provenance: Not applicable in the context of an AI/algorithm-based device. This is a traditional medical device submission based on mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood for AI models (e.g., expert annotations) is not relevant for this type of mechanical device submission.
4. Adjudication method for the test set
- Not applicable. This is a traditional medical device submission based on mechanical testing, not a clinical study involving human readers or adjudicators for a test set.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone plate and screw system, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this mechanical device, the "ground truth" would be established by engineering specifications and mechanical testing standards. The performance of the modified plates (e.g., strength, stiffness, fatigue resistance) is measured against established benchmarks and compared to the predicate device's performance. The document only broadly states "testing demonstrated that the modified plates are substantially equivalent to the previously cleared K130009," without detailing the specific engineering metrics or benchmarks.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.