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The Integra TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The TITAN Reverse Shoulder System is indicated for primary fractures, including proximal humeral or revision total shoulder replacement, for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

The Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and four peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations. The implant scope of the RSS is being expanded to include additional options for humeral liners manufactured from highly crosslinked Ultra High Molecular Weight Polyethylene (XLPE) per ASTM F2565. The existing humeral liners are manufactured from conventional UHMWPE per ASTM F648. The change in material allows for improved wear characteristics of the humeral liners.

I am sorry, but the provided text describes a medical device called the "Integra TITAN Reverse Shoulder System" which is a shoulder joint prosthesis. The document is a 510(k) premarket notification from the FDA. This type of document pertains to the mechanical and material characteristics of an implantable device, rather than the performance of a software algorithm or AI-powered diagnostic tool.

Therefore, the requested information regarding acceptance criteria and studies related to AI/software performance is not present in the provided text. The document focuses on bench testing (nonclinical performance data) for the physical properties of the implant, such as fatigue, disassembly, rotational resistance, and wear.

Here's a breakdown of why I cannot fulfill your request based on this document:

• No AI/Algorithm: The Integra TITAN Reverse Shoulder System is a physical medical implant, not a software or AI-driven device.
• No Diagnostic Claims: It does not make diagnostic claims that would require evaluation of metrics like sensitivity, specificity, or reader performance.
• No Test Set/Training Set: Concepts like test sets, training sets, ground truth, expert adjudication, or MRMC studies are irrelevant to this type of device and its regulatory review.

The document states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device." This indicates that the evaluation for this device relies on non-clinical (bench) testing, rather than clinical trials or studies involving human readers or algorithm performance.

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