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The PROMOS® Shoulder is indicated for:

• Advanced wear of the shoulder joint due to degenerative, post-traumatic or rheumatoid arthritis
• Fracture or avascular necrosis of the humeral head
• Post-traumatic loss of joint configuration, especially in the case of functional impairment
• Humerus fracture
  The humeral component is intended for cemented or cementless use.
  The glenoid component is for use with bone cement only.

The PROMOS® Shoulder will help in restoring shoulder motion and eliminating pain.
The glenoid component has a spherical articulating surface with four pegs on the inferior surface for attachment to the bone. It is manufactured from ultra high molecular weight polyethylene (UHMWPe). The glenoid is available in four sizes with each size having three different spherical radii of curvature for a total of twelve glenoid components.
The humeral component is modular with a distal stem, body, inclination set and humeral head. The distal stem is rectangular in cross sectional shape and available in seven cementless sizes. It is attached to the body via a Morse type taper. Both cemented and cementless stems are fabricated from titanium alloy (Ti6Al4V) that conforms to ISO 5832-3. The body is made of titanium alloy and is available in three sizes. The body has a cavity in the proximal portion to accept the inclination set. The inclination set consists of an insert, offset module and ball screw. The ball screw inserts through the offset module and insert, and the assembly is threaded into the cavity in the body. The offset module can be set at various positions and when the ball screw is tightened into the body the offset module is locked into place. The offset module has a male Morse type taper to which the humeral head is attached. All components of the inclination set are made from titanium alloy. The offset module is available in three different heights resulting in the humeral head being placed at three heights.
The modular humeral heads are manufactured from CoCrMo alloy that conforms to ISO 5832-12. The head is available in eight different sizes.

This document is a 510(k) summary for the PROMOS® Shoulder device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The "Summary Non-clinical Tests" section briefly states: "The results of laboratory testing indicate that the PROMOS Shoulder will survive the expected in-vivo loading." This is a very high-level statement and does not provide quantifiable acceptance criteria or detailed results of the study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you're looking for (performance metrics, study details, sample sizes, etc.) is typically found in the full 510(k) submission, not in the summary document.

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