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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 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 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 and structurally 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 and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System cleared previously in K213856 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 comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty 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 construct is intended to be used with a compatible glenosphere/baseplate component.
The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.

This document is a 510(k) premarket notification decision letter from the FDA to Zimmer Inc. for their Identity Shoulder System. It primarily discusses the substantial equivalence of the device to previously marketed predicate devices.

Based on the provided text, there is no information about testing related to acceptance criteria for an AI device. The document describes a medical device (shoulder system implants), not an AI/software device that would typically have the associated performance metrics (e.g., sensitivity, specificity, accuracy).

The "Non-Clinical Tests Summary & Conclusions" section on page 6 of the provided document does not mention any AI-related tests or performance metrics. The tests listed are:

• Finite Element Analysis (FEA)
• Range of Motion Analysis
• Magnetic Resonance Imaging (MRI)

These are standard engineering and safety tests for implantable medical devices, not performance evaluations for an AI diagnostic or assistance tool. The conclusion states that "Non-clinical testing demonstrated that the new devices do not represent new worst-case configurations than the predicate, and the subject device is substantially equivalent to the predicate device identified." This reinforces that the evaluation was for the physical implant components, not an AI system's performance.

Therefore, since the input document does not pertain to an AI device, I cannot fulfill the request to describe acceptance criteria and associated studies as requested in the prompt's points 1-9.

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