(166 days)
The Synthes 2.7 and 3.5 mm Variable Angle LCP Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The Synthes 3.5mm Low Profile Cortical Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The Synthes 3.5mm Cortex Screws are intended to be used as stand-alone bone screws, or in a platescrew system for internal bone fixation for bone fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The system is a collection of plates used for fixation of fractures of the foot and ankle in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. The complete system includes the following plate types:
• 2.4mm/2.7mm Variable Angle Locking Talus Plate
• 2.7mm Variable Angle Locking Calcaneal Plate
• 2.7mm Variable Angle Locking Anterolateral Calcaneal Plate
• 3.5mm Variable Angle Locking Compression Medial Column Fusion Plate
The system accepts various screw fixation options such as existing cortical, locking, variable angle locking, low profile, cannulated locking, cannulated conical and metaphyseal screws. The plates are low profile in design and offered in variations of Stainless Steel, Commercially Pure Titanium-Grade 4, and Titanium Alloy (TAN). When used in conjunction with a plate system, the system indications apply to the entire construct, including the screws.
This document describes the Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System. The device is a collection of plates and screws used for the fixation of fractures and other bone conditions in the foot and ankle. The submission is a Traditional 510(k) seeking substantial equivalence to several predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be found for a software algorithm's performance metrics. Instead, the study's goal was to demonstrate substantial equivalence to predicate devices through mechanical testing and engineering analyses. The acceptance criteria implied are that the device's performance in these tests should be equal to or greater than the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fatigue strength of the plates and screw systems | Demonstrated "equal to or greater strength" compared to predicate devices |
| Engineering analyses of the plates and screw systems | Completed, demonstrating "equal to or greater strength" compared to predicate devices |
| Similar indications for use | Yes, explicitly stated |
| Similar design characteristics | Yes, explicitly stated |
| Similar performance characteristics (beyond fatigue strength) | Yes, explicitly stated |
2. Sample Size Used for the Test Set and Data Provenance:
The study primarily involved mechanical fatigue strength testing and engineering analyses of the plates and screw systems. The document does not specify the exact number of samples or specimens used for these tests. Data provenance is not applicable in the context of mechanical testing of physical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The study is a mechanical and engineering evaluation of a medical device, not a diagnostic or AI-based system requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as this was a mechanical and engineering study.
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 device is a bone fixation system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a bone fixation system.
7. The Type of Ground Truth Used:
For the mechanical testing, the "ground truth" would be the measured physical properties (e.g., fatigue life, strength) of the tested devices compared against the known properties of the predicate devices. For the engineering analyses, the "ground truth" would be derived from established engineering principles and material science data.
8. The Sample Size for the Training Set:
Not applicable. This is a mechanical device, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.