(62 days)
PERI-LOC* Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC° contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC* VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.
PERI-LOC™ Periarticular Locked Plating System - VLP Plates and Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K062216. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ VLP locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text is a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System. This type of submission is for medical devices and does not contain acceptance criteria or a study that evaluates the performance of an AI/ML powered device.
Instead, a 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device. This typically involves:
- Comparison of technological characteristics: Showing the new device has similar design features, materials, and technological properties to the predicate.
- Comparison of indications for use: Demonstrating that the new device is intended for the same population and conditions as the predicate.
- Performance testing (mechanical/biocompatibility): This usually involves non-clinical bench testing to ensure the device meets specified engineering and safety standards, but these are not the same as clinical studies evaluating AI model performance.
Therefore, I cannot extract the requested information from the provided text because it describes a traditional medical device (bone plates and screws), not an AI/ML powered device. The questions you've asked are relevant for AI/ML device submissions, which typically require different types of studies and acceptance criteria.
§ 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.