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The Exactech® Equinoxe® Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe® Reverse Shoulder is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The proposed Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is a modification to the existing Equinoxe® Reverse Shoulder System humeral adapter tray devices previously cleared in K063569. The +15mm humeral adapter tray mates with previously cleared Equinoxe primary press-fit, primary cemented, and cemented revision/long humeral stems (042021) and the Equinoxe reverse shoulder components (K063569). The rationale for the device line extension is to offer an additional size of offset to tension the deltoid and provide stability.

I am sorry, but I cannot provide the requested information because the provided text describes a medical device clearance (a 510(k) submission) for a physical medical device (shoulder prosthesis), not an AI/software device.

The questions you've asked, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," are specific to the evaluation of AI algorithms or software as a medical device (SaMD). These types of studies are not typically performed for the clearance of a mechanical orthopedic implant like the Exactech® Equinoxe® Reverse Shoulder System.

The document discusses the substantial equivalence of a new humeral adapter tray to a previously cleared device based on engineering studies and material properties, not on AI performance metrics or clinical ground truth derived from expert readers.

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