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Proximal and distal fractures including joint fractures of the humerus, tibia and other long bones
Metaphyseal, supracondylar, peri-articular, intra-articular, intra-articular condylar fractures
Diaphyseal fractures
Ankle fractures
Simple, comminuted and depression fractures
Non-unions and malunions
Osteotomies and bone reconstruction
Fractures in normal or osteoporotic bone

Device Description

This submission is a line extension to the Numelock™ II System and the Stryker® Locked Plating System for various types of locking plates, locking screws and non-locking screws. Plates will be based on the design of the monoaxial plates in the Stryker® Locked Plating System and the polyaxial locking mechanism of the Numelock 10 II plates. The subject plates have locking and non-locking holes and are used with the Ø4.0mm VariAx™ Universal Screws. There is a fully threaded, self-tapping screw and a partially threaded style of screw. All screws will be available sterile and non-sterile. The plates also have holes for standard Kirschner wires to enhance primary plate and fracture fixation or they can be used as suture anchors. Also, compression of the can be applied to the plate using the Universal Screw and act as a lag screw by pulling the bone toward the plate.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VariAx™ Locking Plate System, based on the provided 510(k) summary:

This device is a medical implant and not an AI/ML powered device, therefore, many of the requested fields are not applicable (N/A) to this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Established through Predicate Comparison)	Reported Device Performance
Mechanical Strength: Substantially equivalent to predicate devices in regards to strength.	"The results demonstrate that the subject components are substantially equivalent in strength to the predicate components." (Achieved)
Material: Same as predicate devices.	Substantially equivalent (explicitly stated in "Substantial Equivalence" section).
Design: Same as predicate devices.	Substantially equivalent (explicitly stated in "Substantial Equivalence" section).
Operational Principles: Same as predicate devices.	Substantially equivalent (explicitly stated in "Substantial Equivalence" section).
Intended Use: Same as predicate devices.	Substantially equivalent (explicitly stated in "Substantial Equivalence" section).

Study Proving Acceptance Criteria:

The study conducted to prove the VariAx™ Locking Plate System meets the acceptance criteria was primarily a benchtop mechanical testing and Finite Element Analysis (FEA) study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided document. The statement "FEA and mechanical testing was conducted to compare the strength of the new plates and screws to other plates and screws on the market" implies a set of new plates and screws were tested against predicate devices. The exact number of samples for each test (e.g., fatigue, static strength) is not detailed.
Data Provenance: N/A for this type of mechanical testing. Data is generated in a lab setting rather than from patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. For a device like a bone plate, ground truth is established through engineering specifications and mechanical testing standards, not expert clinical consensus on a test set of data. The "ground truth" here is the pass/fail criteria for mechanical performance defined by industry standards and comparison to predicate devices.

4. Adjudication Method for the Test Set

N/A. This is a mechanical testing study, not a clinical study involving human assessment. Results are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical implant, not an AI/ML powered device. MRMC studies are typically performed for diagnostic or prognostic AI/ML systems where human readers interpret medical images or data.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, effectively. The mechanical testing and FEA study is a standalone evaluation of the device's physical properties. There is no "algorithm" in the sense of AI/ML, but the device's performance is assessed independently of clinical use.

7. Type of Ground Truth Used

Engineering Specifications and Mechanical Standards: The "ground truth" for this device's performance is based on established engineering principles, relevant ASTM or ISO standards for bone fixation devices, and the performance characteristics of predicate devices already on the market. The goal is to demonstrate that the new device's mechanical properties (e.g., strength, durability) are at least equivalent to these accepted benchmarks.

8. Sample Size for the Training Set

N/A. This is a medical implant, not an AI/ML device. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative testing and refinement, but not a formal "training set" as understood in AI.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no AI/ML training set, this question is not applicable. The design "ground truth" for this device would be established through established biomechanical principles, material science, and clinical requirements for fracture fixation.

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