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Hemiarthoplasty/Conventional Total Application:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Correction of functional deformity.
• · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
  · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
  Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
  Reverse Application:
  Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.
  The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
  The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).
  The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.

This FDA 510(k) summary for the "Identity Shoulder System" does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The document is a premarket notification for a medical device seeking substantial equivalence to previously cleared devices. It primarily focuses on:

• Indications for Use: What the device is intended for (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures).
• Device Description: A high-level overview of the components and configurations (hemiarthroplasty, total shoulder replacement, reverse configuration).
• Technological Characteristics: How the device is similar to predicate devices in terms of intended use, indications for use, materials, design features, and sterilization.
• Non-Clinical Tests/Justifications: A list of non-clinical tests performed (e.g., FEA, Axial Pull Off, Fatigue, Corrosion) to support substantial equivalence, but no results or acceptance criteria are provided for these tests in this summary document.
• Clinical Tests: Explicitly states "None provided."

Therefore, based solely on the provided text, I cannot answer the requested questions regarding acceptance criteria and studies proving the device meets them because this information is not present. This type of detail is typically found in the full 510(k) submission, not in the public summary.

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