(71 days)
The system is intended for use in internal fixation of small bones including the hand, foot, and craniomaxillofacial skeleton.
The Profyle Hand and Small Fragment System is a series of titanium plates and screws with plates of varying lengths and thicknesses and configurations including straight, L, T, Y. Z. rectangular, and condylar head options. These plates are attached to bone using 1.2-2.7 mm diameter titanium bone screws; screw diameter is dependent upon plate thickness. All screws are fully threaded and selftapping with cross-slotted heads.
This is a 510(k) summary for a medical device called the "Profyle™ Hand and Small Fragment System", which is a small bone plating system. This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to existing legally marketed devices.
Based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or any form of AI/algorithm-related studies.
The document focuses on:
- Device identification: Proprietary name, common name, classification, regulatory class, product code.
- Device description: Materials (titanium plates and screws), configurations (various plate shapes and sizes), intended use (internal fixation of small bones in hand, foot, craniomaxillofacial skeleton).
- Substantial equivalence claim: Comparison to previously marketed predicate devices (Lunn Fixation System, Synthes Small Fragment and Mini Set, Wurzburg Titanium Mini Bone Plates and Screws) based on intended use, design, materials, and operating principles.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics as this information is not present in the provided 510(k) summary.
The type of studies and data you are asking for (e.g., performance metrics, expert adjudication, AI impact) are typically associated with clinical trials or performance evaluation studies, which are not detailed in this particular 510(k) summary focused on substantial equivalence.
§ 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.