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Intended Use: The subject humeral stem is designed for use as the portion of the shoulder prosthesis that replaces the proximal humerus upon which a prosthetic humeral head is attached to articulate with the natural glenoid fossa or a prosthetic glenoid replacement. The DePuy Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.

Indications for Use: Total Shoulder or hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.

Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.

Glenoid components of the Global AP™ Shoulder are indicated only for use with bone cement for the above indications.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
3. Deformity and/or limited motion.

The subject Global APTM humeral stems are made from titanium alloy and are porouscoated with commercially pure titanium. The stems are available in six sizes. They are identical in design to the Global APTM Humeral Stems cleared in K060874 on June 28, 2006 with the addition of Porocoat® porous coating applied to the proximal portion of the stem.

The provided text is a 510(k) summary for a medical device, the DePuy Global AP™ Porous Coated Humeral Stem. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a device meets specific performance-based acceptance criteria through empirical testing.

Therefore, the document does not contain information about acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) of a device, nor does it describe a study specifically designed to prove the device meets such criteria.

The 510(k) summary explicitly states:
"The DePuy Global AP™ Porous Coated Humeral Stem is substantially equivalent to the previously cleared DePuy Global AP™ Shoulder System (K060874) and the Global® Advantage Shoulder Humeral Stem with Porocoat® (K011047) based upon intended use, indications for use, design, materials, packaging and sterilization. The subject device does not raise any new issues of safety or effectiveness."

This indicates that the approval is based on equivalence to existing devices that have already demonstrated safety and effectiveness, not on new performance testing with defined acceptance criteria.

Thus, I cannot fill in the requested table and information about acceptance criteria and a study given the provided text.

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