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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.

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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 plates intended to treat fractures of the distal humerus and proximal ulna. A variety of plate configurations are included in the system to allow for fixation of multiple fracture patterns. Specifically, the system includes several plate configurations for fixation of the distal humerus which are intended to be used in a two-plate construct where plates are positioned medially and laterally. Additionally, the system includes plates for fixation of the olecranon and proximal ulna. In its entirety, the following plate types are included in the system:
• Medial Distal Humerus Plate
• Lateral Distal Humerus Plate
• Olecranon Plate
• Proximal Olecranon Plate
• Extra-articular Proximal Ulna Plate
The system accepts existing cortical and locking screws as well as new metaphyseal screws, and allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use and will be offered in both stainless steel and titanium.

This document describes the Synthes Variable Angle LCP Elbow System, a medical device for fixing elbow and ulna fractures. The information provided is a 510(k) summary and an FDA clearance letter. It is not a study demonstrating the device meets acceptance criteria related to software or AI.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/software device cannot be extracted from this document. This submission pertains to a traditional medical device (bone fixation plates and screws) and primarily relies on mechanical performance testing and substantial equivalence to predicate devices.

However, I can provide what information is available based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantified acceptance criteria (e.g., specific thresholds for strength or fatigue life) nor does it report detailed performance results in the way an AI/software study would. Instead, it states:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the document, as it describes mechanical testing of physical implants, not a data-driven AI/software study. "Test set" in this context would refer to the physical samples of the device tested, but their number is not specified, nor is the origin of "data" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for this type of device is established through engineering and biomechanical principles, material science, and testing standards, not through expert consensus on medical images or clinical outcomes in the same way as an AI diagnostic tool.

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

Not applicable. This concept is for clinical or image-based ground truth establishment, not mechanical testing.

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

Not applicable. This document is for a bone fixation system and does not involve AI or human "readers" or diagnostic tasks.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance is based on biomechanical engineering principles and testing standards. The company performed "static and fatigue strength testing, as well as engineering strength analyses," comparing the results to predicate devices. This implies that the 'truth' is defined by established mechanical thresholds and the performance of previously cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set.

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