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Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

• Degenerative pathologies: arthrosis, rheumatoid arthritis, posttraumatic arthrosis. Primary and secondary necrosis of the humeral head
• Displaced 4-part upper humeral fracture
• Humeral head fracture
  Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
  Revision surgery when other treatments or devices have failed.

The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder System is intended to accomplish these goals.
It consists of a humeral stem and a humeral head. With these systems the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder.
The modular nature of the system allows for the later conversion of a primary hemi-arthrosplasty to a total shoulder replacement.
The present device submission corresponds to the addition of a new glenoid model to the current cleared model. The new glenoid model is a modification of the shape of the current model. The technological characteristics (materials, manufacturing, sterilization, sizing and indications) of the new glenoid of the Aequalis Shoulder System are similar or identical to the predicate devices.
The glenoid component is made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.

The provided text describes a medical device submission (Aequalis Shoulder System, K063081) but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

This document is a 510(k) premarket notification for a medical device (Aequalis Shoulder System). Such notifications primarily aim to demonstrate substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results against predefined acceptance criteria.

The information provided describes:

• Device Name: Aequalis Shoulder System
• Submitter: Tornier
• Device Classification: Class II, Orthopedic product, Product code HSD
• Equivalent/Predicate Devices: Aequalis Shoulder System (K952928, K043077, K060209); DePuy Global Shoulder System (K060874)
• Device Description: A humeral stem and humeral head for total shoulder replacement or hemi-shoulder. The specific submission is for a new glenoid model, a modification of an existing cleared model, with similar/identical technological characteristics (materials, manufacturing, sterilization, sizing, indications) to predicate devices.
• Materials: Glenoid component made of UHMWPE (ISO standard 5834-2).
• Indications for Use: To relieve severe pain or significant disability caused by degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), primary and secondary necrosis of the humeral head, displaced 4-part upper humeral fracture, humeral head fracture, other pathologies where arthrodesis or resectional arthroplasty are unacceptable, and revision surgery.
• FDA Conclusion: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details because it is not present in the provided document. The document focuses on regulatory approval through substantial equivalence, not detailed performance testing against acceptance criteria.

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