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The Arthrex Mesh Plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

The Arthrex Low Profile Screws (3.0 mm, solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Mesh Plates.

The Arthrex Mesh Plate System is a family of plates and screws made from stainless steel and titanium. The system is comprised of the Arthrex Mesh Plates and accompanying Arthrex Low Profile Screws. The proposed plates in long and short versions are offered sterile and non-sterile.

The accompanying screws are 3.0 mm low profile screws with lengths ranging from 42 mm to 50 mm. The proposed screws are offered sterile and non-sterile.

The provided document is a 510(k) premarket notification for the Arthrex Mesh Plate System, which is a metallic bone fixation appliance and accessories. This type of regulatory submission demonstrates substantial equivalence to legally marketed predicate devices, rather than proving device safety and effectiveness through clinical studies with acceptance criteria as one would find for novel devices or software with AI/ML components.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets.

Instead, the submission relies on:

• Mechanical testing performed in accordance with ASTM F 382-14 (Standard Specification and Test Method for Metallic Bone Plates).
• Bacterial endotoxin testing in accordance with USP .
• Demonstration of substantial equivalence to predicate devices (K111253: Arthrex Distal Extremity Plate System, K143614: Arthrex Low Profile Screws, and K150456: Arthrex Plates, Screws, and Staples) based on intended use, technological characteristics, and mechanical testing data for bending strength, fatigue testing of plates, and torque and pull-out testing of screws.

The document explicitly states: "Any differences between the Arthrex Mesh Plate System and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This indicates that the regulatory pathway is based on demonstrating similarity to existing, approved devices, not on de novo clinical performance studies with specific statistical acceptance criteria that would typically be associated with AI/ML devices.

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