(72 days)
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:
| Criterion | Reported Device Performance |
|---|---|
| Material & Design | "Both the subject Synthes VA Elbow System and predicate Synthes 3.5mm LCP Elbow System and Small Fragment System have similar indications, design characteristics, materials..." |
| Mechanical Performance | "Static and fatigue strength testing, as well as engineering strength analyses, were completed for the plates included in the Synthes Variable Angle LCP Elbow System, demonstrating equal to or greater strength in comparison to the predicate devices and constructs." (This implies the acceptance criterion was "equal to or greater strength" than the predicate devices, but no specific values are given.) |
| Intended Use Equivalence | "similar indications" to predicate devices. |
| Classification Equivalence | Class II, §888.3030, Single/multiple component metallic bone fixation appliances and accessories. Product Code: HRS, HWC (This confirms it fits the same regulatory classification as the predicate). |
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.
§ 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.