Search Results

The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:

• A VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;

• VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions :

• A VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular);

• Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).

Anatomic Bone Plate is mainly used for internal fixation of fracture. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends. Anatomic Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

Anatomic Bone Plate are made of titanium alloy following ASTM F1472 or unalloyed titanium following ASTM F67.

This document is a 510(k) premarket notification for a medical device called "Anatomic Bone Plate." It does not include information about acceptance criteria or a study proving that an AI/software device meets those criteria. The submission is for a traditional medical device (an orthopedic implant), not a software device, and therefore the types of studies and acceptance criteria you are asking for (related to AI performance, ground truth, expert consensus, MRMC studies, etc.) are not applicable here.

The document discusses:

• Device Description: Anatomic Bone Plate, made of titanium alloy, for internal fixation of fractures.
• Indications for Use: Internal fixation of fractures, fracture dislocations, osteotomies, and mal/non-unions in various bones (clavicle, pelvis, upper and lower extremities).
• Comparison to Predicate Device: States substantial equivalence in regulatory classification, indications for use, materials, and design features to a predicate device (K130108).
• Non-Clinical Performance Data:
  • Biocompatibility testing: Performed according to FDA Guidance "Use of International Standard ISO 10993-1".
  • Mechanical testing: Performed per ASTM F382-17 (Standard Specification and Test Methods for Metallic bone plate) and a three-point bending test method to determine bending stiffness, strength, and structural stiffness. This is to demonstrate substantial equivalence in safety and efficacy.
• Clinical Data: States that "Clinical literature was provided to demonstrate substantially equivalence."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/software device meets acceptance criteria, as this document pertains to a physical orthopedic implant and not a software device.

Ask a specific question about this device