Search Results

The Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically,
· Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
· Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

The Synthes Variable Angle LCP Elbow System contains posterolateral and medial plates intended to treat fractures of the distal humerus. The plates are used together in a two-plate, 90° construct and accept existing screws. New 2.7mm Metaphyseal Screws are also compatible with the System.

This document, K120717, describes the Synthes Variable Angle LCP Elbow System. It's a 510(k) premarket notification for a medical device. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes mechanical testing and engineering analysis, not a clinical study involving human patients or analysis of patient data. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data doesn't apply here. The "sample size" would refer to the number of devices or components tested in the mechanical experiments, but this specific number is not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device's performance was evaluated through mechanical testing against engineering standards and comparison to predicate devices, not by expert consensus on clinical outcomes or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable as there was no clinical test set requiring adjudication in this 510(k) summary.

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

This question is not applicable. This 510(k) pertains to a bone fixation system (hardware), not an AI/software device that would involve human readers or image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by engineering standards and direct comparison of mechanical properties to legally marketed predicate devices. Specifically, the ground truth is that the new device's mechanical strength must be "equal to or greater" than the predicate devices. This is assessed through physical testing methods, not clinical outcomes or expert consensus.

8. The sample size for the training set

This question is not applicable. This is a hardware device; there is no "training set" in the context of an algorithm or AI. The development process would involve engineering design, finite element analysis, and prototyping, not data-driven training as understood in AI.

9. How the ground truth for the training set was established

This question is not applicable for the reasons stated above.

Summary of the Study:

The primary study type conducted for this 510(k) submission was mechanical testing and engineering analysis. The goal was to demonstrate that the new Synthes Variable Angle LCP Elbow System (specifically, the Medial and Posterolateral Distal Humerus Plates and 2.7mm Metaphyseal Screws) is substantially equivalent to predicate devices (Synthes 3.5mm LCP Elbow System (K033995) and Synthes Small Fragment System (K000684), and existing 2.7mm VA Locking Screws (K100776)).

The study found that the new device's components exhibited "equal to or greater strength" in static and fatigue testing compared to the predicate devices and constructs. This demonstrates that the device meets the performance requirements for its intended use, which is critical for bone fixation implants expected to withstand significant biomechanical forces.

Ask a specific question about this device