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The ACE® Proximal Humeral Nail is a single use device intended for fixation of proximal humeral fractures.

The ACE® Proximal Humeral Nail System is indicated for fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

The ACE® Proximal Humeral Nail System consists of an intramedullary nail, a slecve, and an end cap and is intended for the fixation of proximal three part humeral fractures. The short, straight nail is available in diameters of 8 and 10 millimeters and length of 150mm. It is designed to be inserted antegrade, in line with the intramedullary canal. The sleeve has been designed to lock all proximal screws to prevent backing out.

This document is a 510(k) Summary for the DePuy ACE® Proximal Humeral Nail System. It describes the device, its intended use, indications for use, and establishes substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

Medical device 510(k) submissions, especially for devices like this intramedullary fixation rod, often demonstrate substantial equivalence through comparisons to predicate devices in areas like:

• Intended Use: The purpose for which the device is used.
• Indications for Use: The specific conditions or diseases the device is indicated to treat.
• Technology: The fundamental scientific technology used by the device.
• Materials: The materials from which the device is constructed.
• Design: The physical characteristics and configuration of the device.
• Performance: Mechanical and/or biological performance (e.g., sterilization, biocompatibility, mechanical strength).

The provided text explicitly states that "The substantial equivalence of the ACE® Proximal Humeral Nail is substantiated by its similarity in intended use, indications for use, materials and design to the Acumed Polarus (K951740) and the Fournitures Hospitaliéres Industrie Telegraph® Humcral Nail (K023241)."

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them. This type of information is not typically presented in the 510(k) Summary itself for this class of device, but would be found in the full 510(k) submission, which might include design verification and validation testing reports (e.g., mechanical testing, biocompatibility testing) comparing the new device to the predicate.

In summary, the provided document does not contain the information required to answer your request about acceptance criteria and a study demonstrating device performance against those criteria.

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