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The Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenohumeral joint in the presence of complex fractures (i.e., 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.

The Synthes Epoca Shoulder Prosthesis System is intended for partial or total replacement of the shoulder joint. The Synthes Epoca Shoulder Prosthesis System consists of metallic cemented and uncemented fixation stems (available with HA coating), humeral heads, an eccenter offset adjustment mechanism, and UHMWPE glenoid components. The components are available in a variety of sizes for primary and revision applications. The components are manufactured from CoCrMo Alloy, Titanium, and Ultra-High Molecular Weight Polyethylene (UHMWPE).

This document is a 510(k) summary for the Synthes Epoca Shoulder Prosthesis System, HA Coated Stems. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study proving device performance against specific acceptance criteria.

Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and training set ground truth establishment) cannot be answered because the provided document does not contain this information.

The document does present the Device Name, Intended Use, and Predicate Devices, which are relevant to establishing substantial equivalence. However, it does not include a study with acceptance criteria and device performance results in the format requested.

The information primarily consists of regulatory details, such as device classification, contact information, and a re-affirmation of the indications for use. There is no evidence of a specific study designed to measure the device's performance against predefined acceptance criteria for attributes like accuracy, precision, or improved human performance.

In summary, the provided text is a regulatory submission for device clearance, not a clinical or performance study report.

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