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The 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 stems are intended for cemented and cementless use. The scope of the RSS is being expanded via a line extension to include additional options for baseplates, glenospheres, and screws. The baseplate option features a smaller post in comparison to the currently commercialized baseplate options, along with glenospheres that work in conjunction with the baseplate. The baseplate under this line extension is referred to as the Small Post Baseplate (SPB). Additional Star screw options have also been incorporated as part of the line extension.

The provided text is related to a 510(k) premarket notification for a medical device: the Integra TITAN Reverse Shoulder System. It describes the device, its intended use, and the nonclinical performance data used to demonstrate substantial equivalence to a predicate device.

However, the text does not contain any information about:

• Acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) for an AI/algorithm-based device.
• A study comparing algorithm performance against a ground truth or human readers.
• Sample sizes for test or training sets for an AI device.
• Ground truth establishment methods (expert consensus, pathology, etc.).
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.

The document is a regulatory submission for a physical medical implant (shoulder prosthesis) and focuses on engineering testing (e.g., fatigue, taper disassembly, torsional properties) to demonstrate mechanical equivalence, not the performance of a diagnostic or AI-driven device. The "Clinical Performance Data" section explicitly states: "Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device."

Therefore, I cannot provide the requested information based on the provided text, as it describes a different type of medical device and regulatory submission where AI performance metrics are not applicable.

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