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The I.T.S. Distal Humeral Plates with Angular Stability is a titanium implant fracture fixation system for stabilizing fractures of the distal humerus in the elbow of a pediatric or adult patient.

Indications for Use include intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The I.T.S. GmbH Distal Humeral Plates with Angular Stability is a fracture fixation plating system for repairing factures located in the distal area of the humerus in the elbow (in the area of medial and lateral epicondyles of the distal humerus). The Distal Humeral Plates consist of two plate designs as a medial (8 hole) and dorsolateral (5 hole) left and right plate configuration - anatomically pre-contoured to fit the distal humerus human anatomy and manufactured from Commercialy Pure (CP) Titanium material for minor intra-operative forming by the surgeon. The offset opposite location of the plates on the medial and lateral epicondyles provide a girder-like construct for difficult bone fracture reconstruction stability. The added benefit of locking screws within each plate and up to a +- 15° angle position allows a fixed-angle contruct of screw-to-plate and offers angle-flexibility in screw positioning for further optimal fracture stability. Small holes in the plate allow intermediate 'k-wire bone fracture segment positioning' for reducing and aligning the fracture bone segments while positioning the plates and introducing multiple sizes of locking/non-locking screws as needed for stabilizing the fracture(s) - when using optional x-ray fluroscopy. The system offers a 3.5mm locking and non-locking cortical screw and a 4.2mm locking cancellous screw in multiple lengths manufactured from High Strength 6-4 Alloyed Titanium material. All plates and screws are processed with a TIODIZE II surface treatment - which improves the material surface hardness and biocompatibility to adjacent tissues. The low-profile and contoured left and right plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.

I am sorry but the provided text does not contain information about acceptance criteria, device performance results, or a clinical study. The document is a 510(k) summary for a medical device (Distal Humeral Plates with Angular Stability) seeking marketing clearance based on substantial equivalence to predicate devices, not on direct performance against acceptance criteria from a study. It outlines the device description, intended use, and substantial equivalence to legally marketed devices. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.

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