(25 days)
The Synthes 4.5mm VA-LCP Curved Condylar Plate System is indicated for buttressing mutifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
The Synthes 4.5mm VA-LCP Curved Condylar Plate System consists of anatomically contoured, stainless steel and titanium plates featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur.
This document is a 510(k) summary for the Synthes 4.5mm VA-LCP Curved Condylar Plate System. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the way a diagnostic AI device might.
Therefore, the requested information elements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC study, standalone performance, training set details) are not applicable or available within this document. This document describes a medical device (surgical plates and screws) and its regulatory clearance process, which relies on demonstrating substantial equivalence to existing devices through mechanical testing and comparison of design, materials, and intended use, rather than clinical performance metrics in the way a software algorithm would be evaluated.
Here's what can be extracted based on the provided text:
- Device Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System
- Intended Use: Buttressing multifragmentary distal femur fractures including: supracondylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
- Predicate Device: Synthes 4.5mm VA-LCP Curved Condylar Plates (K083025)
- Study Type: Mechanical testing was performed comparing the proposed plates to the predicate plates.
- Acceptance Criteria (Implicit): The implicit acceptance criterion is "substantial equivalence" to the predicate device. This means the new device must perform comparably in terms of mechanical properties and not raise new questions of safety or effectiveness. The text states: "...the results support substantial equivalence."
- Ground Truth (for mechanical testing): Not explicitly stated as "ground truth" but the predicate device serves as the standard for comparison in mechanical testing.
- Sample Size (for testing): Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary, as this is mechanical testing, not clinical data provenance.
- Experts/Adjudication/MRMC/Standalone Performance/Training set: These concepts are not relevant to the type of device and regulatory submission described in the document. The clearance is based on mechanical performance and design similarity, not analysis of clinical images or data by AI.
§ 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.