(140 days)
The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains smooth variable angle locking pegs and K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.
The provided text describes the OsteoMed ExtremiLOCK Wrist Plating System, a medical device, and the basis for its 510(k) clearance. It does not contain information about a study proving that the device meets acceptance criteria related to a diagnostic or AI-driven system.
The "Performance Characteristics & Testing & Clinical" section explicitly states: "Clinical Testing is not required to support substantial equivalence." Instead, the performance evaluation was based on mechanical strength testing of the plates and screws compared to predicate devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving a device meets them, as the provided document does not detail such a study in the context of diagnostic performance, AI, or human-in-the-loop improvements. The information requested (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typical for the validation of diagnostic algorithms or AI systems, which is not what this document describes for the OsteoMed ExtremiLOCK Wrist Plating System.
The document focuses on the mechanical and material performance of a bone fixation system, establishing substantial equivalence to existing predicate devices based on:
- Mechanical strength testing: Plates and screws were tested against predicate devices to ensure they met required mechanical strength criteria for their intended use.
- Material comparison: The system uses materials (Titanium, Titanium Alloy, Stainless Steel) per ASTM standards, similar to predicates.
- Design and Technology: Similarities in design, technology (e.g., variable angle locking), and operational principles to predicates.
In summary, the provided text discusses regulatory clearance for a medical device based on non-clinical, mechanical performance comparisons, not a clinical study assessing diagnostic accuracy or AI performance.
§ 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.