(125 days)
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, fibula and calcaneus.
VLP FOOT Plating System and PERI-LOC Ankle Fusion Plating System bone plates and bone screws are for single use only.
The subject devices are comprised of locking bone plates and locking and non-locking bone screws. All described implant components are manufactured from stainless steel material. The subject implant devices are available in the following size ranges:
| Device Type | Available Length Range |
|---|---|
| VLP 2.5mm Talus Plates | 20 – 25mm |
| PERI-LOC 3.5mm Anterior Primary Ankle Fusion Plates | 66 - 92mm |
| PERI-LOC 3.5mm Hindfoot Ankle Fusion Utility Plates | 79 – 104mm |
| PERI-LOC 3.5 and 4.5mm Posterior Ankle Fusion Plates | 80mm |
| PERI-LOC 4.5mm Lateral Tibiotalcaneal Ankle Fusion plates | 120mm |
| VLP 2.7mm Percutaneous Calcaneus Plates | 55 – 62mm |
| VLP 2.5mm T7 Locking Cortex Screws | 6 – 50mm |
| VLP 2.7mm Locking Cortex Screws | 42 - 50mm |
| VLP 4.0mm Fully Threaded Osteopenia Screws | 42 - 50mm |
| VLP 4.0mm Locking Osteopenia Screws | 42 – 50mm |
| VLP 4.0mm Partially Threaded Osteopenia Screws | 42 - 50mm |
Device specific instruments are also described in this premarket notification in select sections and exhibits.
This document is a 510(k) summary for medical devices, specifically bone plates and screws. It details the device description, intended use, and substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study results in the context of an AI/ML device.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, experts, adjudication, or MRMC/standalone studies as this information is not present in the provided text.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Similar Indications for Use: The VLP FOOT Plating System and PERI-LOC Ankle Fusion Plating System have similar indications for fracture fixation, reconstruction, arthrodesis, and ankle arthrodesis as the predicate devices.
- Similar Materials: All described implant components are manufactured from stainless steel, similar to predicate devices.
- Similar Technological Design Characteristics: The components are "very similar" to legally marketed predicate devices.
- Pre-clinical Testing: Engineering analysis, four-point bend fatigue testing of plates, and construct fatigue testing of plate/screw constructs were conducted to further support substantial equivalence.
In summary, this document is a regulatory submission for a traditional medical device (bone plates and screws), not an AI/ML powered device, and thus does not contain the information required to answer your questions regarding acceptance criteria and performance studies for an AI/ML 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.